PCTU  Logo for websiteThe Pragmatic Clinical Trials Unit (PCTU) leads and supports clinical trials in which the primary question of interest relates to intervention effectiveness: whether an intervention works under real-life conditions.

It also leads and supports pilot studies for these trials. Currently, the unit focuses on trials of complex interventions, and on trials designed to understand processes explaining effectiveness, but also supports a small number of other pragmatic trials. In addition, the unit leads methodological research relevant to its focus.

The aim of the unit is to lead, support and encourage high quality pragmatic trials and pilot studies particularly where they fit with the research strategies of the two centres with which the unit is linked, or with the methodological interests of the unit.

About us

The PCTU is based in the Centre for Primary Care and Public Health and linked to the Centre for Psychiatry. We have been conducting pragmatic clinical trials since the mid 1990s. We have considerable experience and expertise in primary care, community-based and mental health trials, and particularly cluster randomised trials and trials of complex interventions and behaviour change.

We are a UK Clinical Research Collaboration (UKCRC) registered clinical trials unit.

This unit receives National Institute for Health Research CTU Support Funding. This funding has been awarded to support the unit in developing and supporting NIHR trials. 

UKCRC logo low res 

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What does a clinical trials unit do?

The UKCRC defines a clinical trials unit as a unit with overall responsibility for the design, recruitment, data management, publicity and analysis of multi-centred randomised controlled trials or other well-designed studies, working in any disease/topic area. There are more details on their website.

Some trials units are generic, covering all types of trial and disease areas. Other trials units, like the PCTU, have a more specific focus.

Research

Current Projects

The PCTU is currently involved in these projects, which are at varying stages of completion and led by a variety of investigators. For further information please click on the title.

TrialsPeakflow Meter  XSmall

DAPPA - How accurate is spot urinary protein:creatinine ratio (SPCr) and spot albumin:creatinine ratio (SACr) compared to 24-hour protein estimation to assess women with hypertensive disease in pregnancy (HDP) after 24 weeks gestation.

EMPIRE - Antiepileptic drug (AED) management in Pregnancy: An evaluation of effectiveness, cost effectiveness and acceptability of dose adjustment strategies

ENRICH - Enhanced discharge from inpatient to community mental health care (ENRICH): a programme of applied research to manualise, pilot and trial a Peer Worker intervention

EPOCH - Enhanced Peri-Operative Care for High-risk patients (EPOCH) Trial. A stepped wedge randomised cluster trial of an intervention to improve quality of care for patients undergoing emergency laparotomy

ESTEEM: Effect of simple, targeted diet in pregnant women with metabolic risk factors on pre-eclampsia: A randomised trial

FIAT - Financial incentives to improve adherence to anti-psychotic maintenance medication in non-adherent patients – a cluster randomised controlled trial

HABSelect - Hyaluronic Acid Binding for Sperm sELECTion

IPPIC - Accuracy of clinical characteristics, biochemical and ultrasound markers in the prediction of preeclampsia: an Individual Patient Data (IPD) Meta-analysis

LSI - What makes online patients' communities effective: An interdisciplinary study informed by network analysis.

MEDAL- Can magnetic resonance imaging (MRI) scan replace or triage the use of laparoscopy in establishing a diagnosis among women presenting in secondary care with chronic pelvic pain (CPP)?

mEsh - Multi-disciplinary Evidence Synthesis Hub (mEsh) 

NESS - Effectiveness and Cost-Effectiveness of Body Psychotherapy in the Treatment of Negative Symptoms of Schizophrenia – A multi-centre randomised controlled trial

PACE-UP - Randomised controlled trial of a pedometer-based walking intervention with and without practice nurse support in primary care patients aged 45-74 years

PIMS - A multicentre interventional comparative randomised controlled clinical trial comparing face-down positioning, with an inactive face-forward position on the outcome of surgery for large macular holesPositioning in Macular hole Surgery (Positioning in Macular hole Surgery)

SALVO - A randomised controlled trial of intra-operative cell salvage during caesarean section in women at risk of haemorrhage

SWAP - A peer-support weight management programme to supplement brief advice in general practice for obese adults from deprived communities

TANDEM - A tailored, psychological intervention for mild to moderate anxiety or depression in people with chronic
obstructive pulmonary disease(COPD).

Programmes

CapaCiTY - Chronic Constipation Treatment pathwaY

EPOS - Effective patient-clinician interaction to improve treatment outcomes for patients with psychosis

HepFree – Chronic viral hepatitis in ethnic minorities. Strategies to prevent the predicted increase in mortality

QuEST – Quality and Effectiveness of Supported Tenancies for people with mental health problems

STOP - Optimising pharmacist-based treatment for smoking cessation

VOLUME - Volunteering in Mental Health Care for People with Psychosis

Other studies

iWIP - Effects of weight management interventions on maternal and fetal outcomes in pregnancy: Individual patient data (IPD) meta analysis of randomised trials and model based economic evaluation

PREP - Development and validation of a Prediction model for Risk of complications in Early onset Pre-eclampsia

START - Systematic Techniques for Assessing Recruitment to Trials: a programme to test recruitment interventions

Completed Projects and Publications

Below is a list of projects that PCTU staff have been involved with in the past. These projects are now completed and resulting publications as well as further information on the trial will be available from links below.

Trials

AdjuVIT - Does vitamin D enhance response to treatment in smear positive pulmonary tuberculosis? A double-blind randomised placebo-controlled trial

BELLA - Development, pilot and feasibility study for a chronic obstructive pulmonary disease (COPD) specific version of the Expert Patients Programme (EPP)

Body Psychotherapy - Effectiveness and processes of body psychotherapy in Chronic schizophrenia

Calcitriol trial - Does 1,25-dihydroxyvitamin D3 (calcitriol) enhance corticosteroid activity in steroid-refractory asthma?

ComQuol – A pilot trial to assess the effect of a structured Communication approach on QUality Of Life in secure mental health settings

CONFIDeNT - Control of faecal incontinence using distal neuromodulation

DIALECT - Dialectical-behaviour therapy for people with borderline personality disorders and self harm - a pragmatic pilot trial

The Diabetes Manual - Effectiveness of patient self-managed structured education for type 2 diabetes: a cluster randomised-controlled trial

IRIS - Primary care Identification and Referral to Improve Safety of women experiencing partner violence: a randomised controlled trial

MEDEA - Does the chronic disease self-management programme (expert patient programme) improve metabolic control of diabetes? A randomised controlled trial

Music Therapy - Group music therapy for patients with treatment resistant posttraumatic stress disorder – a pilot randomised controlled trial

OEDIPUS - Can education for South Asians with asthma and their clinicians reduce unscheduled care? A cluster randomised trial and qualitative evaluation

OPERA - Older people's exercise intervention in residential nursing accommodation

PRISMS - A rapid synthesis of the evidence on interventions supporting self-management for people with long-term conditions

RHIVA 2 - Effectiveness of HIV screening in primary care: a cluster RCT and economic analysis

SNS vs PTNS - A randomised mixed methods pilot (phase II exploratory trial) of sacral and percutaneous tibial nerve stimulation for faecal incontinence

WAIT - Parent-determined oral montelukast therapy for preschool wheeze with stratification for arachidonate-5-lipoxygenase (ALOX5) promoter genotype

Programmes

COPERS - COping with Persistent Pain, Effectiveness Research into Self-management

OViD - Effectiveness of vitamin D supplementation to prevent acute respiratory illness and reduce health care use. The OViD programme encompasses the following trials:

  • ViDiAs
  • ViDiCO
  • ViDiFlu

Other studies

ASAP - Is poor educational attainment in white and Bangladeshi children related to asthma? A study linking health, education and social care datasets

GEM Study (Guided E-learning for Managers ) - Pilot study of a randomised trial of a guided e-learning health promotion intervention for managers based on management standards for the improvement of employee wellbeing and reduction of sickness absence

HiLo - High blood pressure control and lipid Lowering in patients at high cardiovascular risk: a cluster-randomised factorial comparison of educational and protocol

Health Equity Project

LEZ - Impact of the London Low Emission Zone on Children's Respiratory HealthLondon Traffic Small

LPE /Homeless study - Discharge planning for the homeless, examining The London Pathway. Does a GP led discharge team reduce the in-patient burden and improve quality of care?

NHS health checks - NHS Health Checks Evaluation

TOPAS - Measuring and understanding the meaning of chronic widespread pain amongst Bangladeshis in Tower Hamlets, East London

Methodology

We undertake methodological research emerging directly out of discussions and deliberations around specific trials; this is an important part of the way in which we ensure that we stay at the forefront of the science and execution of pragmatic trials. Important and interesting questions can often be answered in a short time frame with no need for external funding. Senior academic staff also have their own longer term research interests. In particular we have long term interests in cluster randomised trials, pilot and feasibility studies, innovative trial design, and best practice in the design, analysis and reporting of trials. We try to keep a balance between following interesting new avenues and focusing on specific areas.

 

Theme 1: Cluster Randomised Trials

A cluster randomised trial (CRT) is a randomised controlled trial in which pre-existing groups, called clusters, of individuals are randomly allocated to treatment arms. For example, clusters may be clinical practices or schools where the individuals are patients and school children, respectively. CRTs can be used when individual randomisation to treatment arms is not possible or the intervention is naturally applied to a whole cluster. A cluster randomised design is associated with a loss in statistical power and additional complexity in design, conduct and analysis. Extensions to the cluster randomised design include cluster randomised crossover trials and stepped wedge trials. We provide a course “A Practical Guide to Cluster Randomised Trials” based on a book written by Sandra Eldridge and Sally Kerry. We also organise a meeting “Current Developments in Cluster Randomised and Stepped Wedge Designs” for talks and discussion about new perspectives for the design, analysis and reporting of cluster randomised and stepped wedge trials. 

Specific topics of our work include:
Design
Sample size calculation
Recruitment and consent
Use and reporting of covariates
Analysis
We have also conducted several systematic reviews of CRTs

References to our published papers include:
Eldridge, S., & Kerry, S. (2012). A Practical Guide to Cluster Randomised Trials in Health Services Research. John Wiley & Sons.

Hooper, R., & Bourke, L. (2015). Cluster randomised trials with repeated cross sections: alternatives to parallel group designs. BMJ, 350. http://doi.org/10.1136/bmj.h2925

Arnup, S. J., Forbes, A. B., Kahan, B. C., Morgan, K. E., McDonald, S., & McKenzie, J. E. (2014). The use of the cluster randomized crossover design in clinical trials: protocol for a systematic review. Systematic Reviews, 3(1), 1–6. http://doi.org/10.1186/2046-4053-3-86

Weijer, C., Grimshaw, J. M., Eccles, M. P., McRae, A. D., White, A., Brehaut, J. C., & Taljaard, M. (2012). The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials. PLoS Medicine, 9(11), e1001346. http://doi.org/10.1371/journal.pmed.1001346

Eldridge, S. M., Ukoumunne, O. C., & Carlin, J. B. (2009). The Intra-Cluster Correlation Coefficient in Cluster Randomized Trials: A Review of Definitions. International Statistical Review, 77(3), 378–394. http://doi.org/10.1111/j.1751-5823.2009.00092.x Sample size calculations for cluster randomised trials, with a focus on ordinal outcomes. (PhD thesis)

Rutterford, C., Copas, A., & Eldridge, S. (2015). Methods for sample size determination in cluster randomized trials. International Journal of Epidemiology, 44(3), 1051–67. http://doi.org/10.1093/ije/dyv113

Rutterford, C., Taljaard, M., Dixon, S., Copas, A., & Eldridge, S. (2015). Reporting and methodological quality of sample size calculations in cluster randomized trials could be improved: a review. Journal of Clinical Epidemiology, 68(6), 716–23. http://doi.org/10.1016/j.jclinepi.2014.10.006

Teerenstra, S., Eldridge, S., Graff, M., de Hoop, E., & Borm, G. F. (2012). A simple sample size formula for analysis of covariance in cluster randomized trials. Statistics in Medicine, 31(20), 2169–2178. http://doi.org/10.1002/sim.5352

Eldridge, S. M., Costelloe, C. E., Kahan, B. C., Lancaster, G. A., & Kerry, S. M. (2015). How big should the pilot study for my cluster randomised trial be? Statistical Methods in Medical Research. http://doi.org/10.1177/0962280215588242

Eldridge, S., Kerry, S., & Torgerson, D. J. (2009). Bias in identifying and recruiting participants in cluster randomised trials: what can be done? BMJ, 339. http://doi.org/10.1136/bmj.b4006

Diaz-Ordaz, K., Slowther, A.-M., Potter, R., & Eldridge, S. (2013). Consent processes in clusterrandomised trials in residential facilities for older adults: a systematic review of reporting practices and proposed guidelines. BMJ Open , 3 (7 ). http://doi.org/10.1136/bmjopen-2013-003057 Choosing covariates in the analysis of cluster randomised trials. (PhD thesis)

Wright, N., Ivers, N., Eldridge, S., Taljaard, M., & Bremner, S. (2015). A review of the use of covariates in cluster randomised trials uncovers marked discrepancies between guidance and practice. Journal of Clinical Epidemiology, 68(6), 603–609. http://doi.org/10.1016/j.jclinepi.2014.12.006

Diaz-Ordaz, K., Kenward, M. G., Cohen, A., Coleman, C. L., & Eldridge, S. (2014). Are missing data adequately handled in cluster randomised trials? A systematic review and guidelines. Clinical Trials (London, England), 11(5), 590–600. http://doi.org/10.1177/1740774514537136

Froud, R., Eldridge, S., Diaz Ordaz, K., Marinho, V. C. C., & Donner, A. (2012). Quality of cluster randomized controlled trials in oral health: a systematic review of reports published between 2005 and 2009. Community Dentistry and Oral Epidemiology, 40, 3–14. http://doi.org/10.1111/j.1600- 0528.2011.00660.x

Diaz-Ordaz, K., Froud, R., Sheehan, B., & Eldridge, S. (2013). A systematic review of cluster randomised trials in residential facilities for older people suggests how to improve quality. BMC Medical Research Methodology, 13(1), 1–10. http://doi.org/10.1186/1471-2288-13-127

Eldridge, S., Ashby, D., Bennett, C., Wakelin, M., & Feder, G. (2008). Internal and external validity of cluster randomised trials: systematic review of recent trials. BMJ, 336(7649), 876–880. http://doi.org/10.1136/bmj.39517.495764.25

Theme 2: Pilot and Feasibility Studies

The number of pilot and feasibility studies in the literature is increasing, but they are often poorly reported. Our research into pilot and feasibility studies aims to improve the conduct and reporting of such studies. Our methodological work in this area is listed below. The group leading this work has also facilitated a number of workshops on conducting pilot and feasibility studies. We also have collaborations with others working on pilot and feasibility studies both in the UK and Canada. 

Specific topics of our work include:
A framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial
A CONSORT extension for pilot and feasibility trials
A systematic review of the reporting quality of pilot and feasibility cluster randomised trials
A simulation study to see how large a pilot study for a cluster randomised trial should be

References to our published papers include:
Sandra M Eldridge, Ceire E Costelloe, Brennan C Kahan, Gill A Lancaster, Sally M Kerry. How big should the pilot study for my cluster randomised trial be? Statistical methods in medical research. 2015

Sandra M Eldridge, Gillian A Lancaster, Michael J Campbell, Lehana Thabane, Sally Hopewell, Claire L Coleman, Christine M Bond. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS ONE. 2016; 11(3)

Theme 3: Innovative Trial Design

In 1948 the UK Medical Research Council’s streptomycin trial established the principles of the modern clinical trial, and since then randomised controlled trials have offered a gold standard for the evaluation of new medical treatments. The parallel groups design used in that first trial has proved to be a remarkably enduring and powerful scheme, but variations and innovations in trial design continue to be explored. Innovation may be needed to tackle practical constraints on trial conduct, but it can also allow us to improve the efficiency of a trial – that is to reduce the number of participants or other resources needed to gather the evidence we need. PCTU has a flourishing methodological research programme centred on innovative trial design.

Specific topics of our work include:

Stepped wedge cluster randomised trials
Stepped wedge trials are cluster randomised trials in which the clusters are sampled repeatedly over time, with different clusters crossing over from the control to the experimental intervention at different times. They can have practical advantages over parallel group trials, but they can also be more efficient in some circumstances. A much fuller understanding has emerged in the last couple of years of the theoretically optimal scheme for a stepped wedge design, but there are still many challenges in the implementation (e.g. preventing attrition bias), analysis (e.g. allowing for complex correlation structures within a cluster over time) and reporting of stepped wedge trials that we are keen to investigate.

Incomplete designs
If individual participants are recruited at a cost (either a financial or an ethical one) then it may not be beneficial to keep recruiting for the full duration at every cluster. Instead an incomplete design – one with gaps in the recruitment schedule – might be preferred. We have been studying the properties of a novel incomplete design called the dog-leg. Though initially proposed for individually randomised trials it is likely to have wider application in cluster randomised trials: among two-stage “crossforward” designs (where clusters are only allowed to cross between interventions in one direction, from the control to the experimental intervention) the dog-leg design will often require the fewest participants. Incomplete designs for cluster randomised trials with more than two stages merit further investigation.

Individually randomised stepped wedge designs
In a cluster randomised trial a stepped wedge design can be more efficient than a parallel groups design. Could a stepped wedge also improve the efficiency of an individually randomised trial? We have identified situations where this is the case, and we are continuing to study how the lessons learned from longitudinal cluster randomised trial design can be taken back to individually randomised trials.

Re-randomisation designs
Re-randomisation designs are individually randomised trials in which participants can be re-enrolled and re-randomised each time they experience a new treatment episode. For example, in a trial comparing two different interventions during pregnancy, participants could be re-randomised for each new pregnancy. This design can facilitate more a more rapid recruitment rate, and could reduce trial costs.

A versatile approach to sample size calculation using simulation
Ensuring the number of participants in a clinical trial is no larger than it needs to be is an important ethical principle. But new developments and increasing complexity in trial design can mean that accurate formulae for calculating sample size are not available (indeed with some adaptive trial designs analytical solutions to sample size calculation problems are simply unattainable). Monte Carlo simulation can help in this case. Simulation has a rough-and-ready reputation, and some statisticians may favour the elegance of an equation even when only approximate, but simulation offers a simple, precise, and versatile approach to sample size calculation that is easily validated by others such as statistical reviewers. We have developed a sample size calculation software add-on for Stata called SimSam that can calculate the sample size needed to achieve given statistical power for any analysis under any data generating model that can be programmed in the host package. 

References to our published papers include:
Hooper R, Bourke L. Cluster randomised trials with repeated cross-sections: alternatives to parallel group designs. BMJ 2015;350:h2935.

Hooper R. Versatile sample size calculation using simulation.Stata Journal 2013;13(1):21-38

Hooper R & Bourke L. The dog-leg: an alternative to a cross-over design for pragmatic clinical trials in relatively stable populations. Int J Epidemiol 2014;43(3):930-936.

Kahan BC et al. A re-randomisation design for clinical trials. BMC medical research methodology. 2015; 15:96

Theme 4: Best Practice in the Design, Reporting and Analysis of Trials

Randomised controlled trials (RCTs) are the gold standard for comparing healthcare interventions, however they require sound design, analysis, and reporting to ensure their results are accurate and robust. The PCTU is involved in a variety of research projects focussing on improving the design, analysis, and reporting of RCTs. 

Specific topics of our work include:

Adjustment for covariates
Adjusting for prognostic covariates in the analysis of RCTs can be beneficial, as it can increase statistical power and precision. Our work has focussed on determining when and how to do this. We have examined whether we need to adjust for stratification or minimisation factors (i.e. variables used to balance treatment groups during randomisation) in the analysis. We have also looked at the best way of adjusting for covariates in the analysis, focussing primarily on how to adjust for centre or site in multicentre trials, and how to adjust for continuous covariates.

Outcome measures
Choosing an appropriate outcome measure and ensuring it is measured or assessed in a valid way is an essential part of designing RCTs. An inappropriate outcome measure (e.g. something that is not relevant to patients) may mean RCT results are not useful. Poor measurement or assessment of outcomes may introduce bias to the trial results. Our work has focussed on choosing appropriate primary outcome measures, as well as how to reduce bias in the assessment of the outcome in openlabel (unblinded) trials where blinded outcome assessment is not feasible.

Reporting
Accurate reporting is essential in RCTs so that others are able understand the trial’s design, conduct, analysis, which allows them to assess the validity of the trial results. Incomplete or inaccurate reporting can hinder this process. We have developed reporting standards and guidelines for embedded recruitment trials (studies within a trial which compare different methods of patient recruitment) and for implementation studies of complex interventions. We have also assessed the reporting quality surrounding outcome assessment, method of randomisation, the analysis of RCTs using stratified randomisation, and the analysis of multicentre RCTs. 

References to our published papers include:

Froud R, Ellard D, Patel S, Eldridge S, Underwood M. Primary outcome measure use in back pain trials may need radical reassessment. BMC Musculoskelet Disord. 2015;16:88.

Kahan BC, Cro S, Dore CJ, Bratton DJ, Rehal S, Maskell NA, et al. Reducing bias in open-label trials where blinded outcome assessment is not feasible: strategies from two randomised trials. Trials. 2014;15:456.

Kahan BC, Rehal S, Cro S. Blinded Outcome Assessment Was Infrequently Used and Poorly Reported in Open Trials. PloS one. 2015;10(6):e0131926.

Kahan BC, Jairath V, Dore CJ, Morris TP. The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies. Trials. 2014;15:139.

Kahan BC, Morris TP. Adjusting for multiple prognostic factors in the analysis of randomised trials. BMC medical research methodology. 2013;13:99.

Kahan BC, Morris TP. Reporting and analysis of trials using stratified randomisation in leading medical journals: review and reanalysis. BMJ. 2012;345:e5840.

Kahan BC, Morris TP. Improper analysis of trials randomised using stratified blocks or minimisation. Statistics in medicine. 2012;31(4):328-40.

Kahan BC, Rushton H, Morris TP, Daniel RM. A comparison of methods to adjust for continuous covariates in the analysis of randomised trials. BMC medical research methodology. 2016;16:42.

Peacock JL, Sauzet O, Ewings SM, Kerry SM. Dichotomising continuous data while retaining statistical power using a distributional approach. Statistics in medicine. 2012;31(26):3089-103.

Kahan BC. Accounting for centre-effects in multicentre trials with a binary outcome - when, why, and how? BMC medical research methodology. 2014;14:20.

Kahan BC, Harhay MO. Many multicenter trials had few events per center, requiring analysis via random-effects models or GEEs. Journal of clinical epidemiology. 2015.

Kahan BC, Morris TP. Analysis of multicentre trials with continuous outcomes: when and how should we account for centre effects? Statistics in medicine. 2013;32(7):1136-49.

Kahan BC, Morris TP. Assessing potential sources of clustering in individually randomised trials. BMC medical research methodology. 2013;13:58.

Morris TP, Kahan BC, White IR. Choosing sensitivity analyses for randomised trials: principles. BMC medical research methodology. 2014;14:11.

Madurasinghe VW, Sandra Eldridge on behalf of MRCSG, Gordon Forbes on behalf of the SECG. Guidelines for reporting embedded recruitment trials. Trials. 2016;17(1):27.

Pinnock H, Epiphaniou E, Sheikh A, Griffiths C, Eldridge S, Craig P, et al. Developing standards for reporting implementation studies of complex interventions (StaRI): a systematic review and e-Delphi. Implement Sci. 2015;10:42.

Kahan BC, Rehal S, Cro S. Risk of selection bias in randomised trials. Trials. 2015;16(1):405.

Rick J, Graffy J, Knapp P, Small N, Collier DJ, Eldridge S, Kennedy A, Salisbury C, Treweek S, Torgerson D, Wallace P, Madurasinghe V, Hughes-Morley A, Bower P. Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials. Trials. 2014;15(1):407.

Froud R, Underwood M & Eldridge S. Improving the reporting and interpretation of clinical trial outcomes. Br J Gen Pract 2012;62(603):e729-731.

Hooper R, Diaz-Ordaz K, Takeda A & Khan K. Comparing diagnostic tests: trials in people with discordant test results. Stat Med 2013;32(14):2443-2456.

Hooper R, Froud RJ, Bremner SA, Perera R, Eldridge S. Cascade diagrams for depicting complex interventions in randomised trials. BMJ 2013;347:f6681

Kahan BC. Bias in randomised factorial trials. Stat Med 2013;32(26):4540-4549.

Choudhury Y, Hussain I, Parsons S, Rahman A, Eldridge S & Underwood M. Methodological challenges and approaches to improving response rates in population surveys in areas of extreme deprivation. Prim Health Care Res Dev 2012;13(3):211-218.

Froud R, Eldridge S, Kovacs F, Breen A, Bolton J, Dunn K, Fritz J, Keller A, Kent P, Lauridsen HH, Ostelo R, Pincus T, van Tulder M, Vogel S & Underwood M. Reporting outcomes of back pain trials: a modified Delphi study. Eur J Pain 2011;15(10):1068-1074.

Nadeem NJ, Taylor SJ & Eldridge SM. Withdrawal of inhaled corticosteroids in individuals with COPD - a systematic review and comment on trial methodology. Respir Res 2011;12:107.

Eldridge S. Pragmatic trials in primary health care: what, when and how? Fam Pract 2010;27(6):591- 592.

Lancaster GA, Campbell MJ, Eldridge S, Farrin A, Marchant M, Muller S, Perera R, Peters TJ, Prevost AT & Rait G. Trials in primary care: statistical issues in the design, conduct and evaluation of complex interventions. Stat Methods Med Res 2010;19(4):349-377.

 

Publications

2015

Eldridge SM, Costelloe CE, Kahan BC, Lancaster GA, Kerry SM. How big should the pilot study for my cluster randomised trial be? Stat Method Med Res 2015;doi: 10.1177/0962280215588242.

Froud R, Ellard D, Patel S, Eldridge S, Underwood M. Primary outcome measure use in back pain trials may need radical reassessment. BMC Musculoskeletal Disorders 2015;16(1):88.

Hooper R, Bourke L. Cluster randomised trials with repeated cross-sections: alternatives to parallel group designs. BMJ 2015;350:h2935.

Kahan BC, Harhay MO. Many multicenter trials had few events per center, requiring analysis via random-effects models or GEEs. J Clin Epidemiol 2015;doi:10.1016/j.jclinepi.2015.03.016.

Kahan BC, Rehal S, Cro S. Blinded outcome assessment was infrequently used and poorly reported in open trials. PLoS One 2015;10(6): e0131926.

Pinnock H, Epiphaniou E, Sheikh A, Griffiths C, Eldridge S, Craig P, Taylor SJC. Developing standards for reporting implementation studies of complex interventions (StaRI): A systematic review and e-Delphi. Implementation Sci 2015;10(1):42.

Rutterford C, Copas A, Eldridge S. Methods for sample size determination in cluster randomized trials. Int J Epidemiol 2015;doi:10.1093/ije/dyv113.

Rutterford C, Taljaard M, Dixon S, Copas A, Eldridge S. Reporting and methodological quality of sample size calculations in cluster randomized trials could be improved: A review. J Clin Epidemiol 2015;68(6):716-723.

Wright N, Ivers N, Eldridge S, Taljaard M, Bremner S. A review of the use of covariates in cluster randomized trials uncovers marked discrepancies between guidance and practice. J Clin Epidemiol 2015;68(6):603-609.

2014

Arnup SJ, Forbes AB, Kahan BC, Morgan KE, McDonald S, McKenzie JE. The use of the cluster randomized crossover design in clinical trials: protocol for a systematic review. Systematic Reviews 2014, 3:86.

Díaz-Ordaz K, Kenward MG, Cohen A, Coleman CL, Eldridge S. Are missing data adequately handled in cluster randomised trials? A systematic review and guidelines. Clin Trials published online 5 June 2014 DOI: 10.1177/1740774514537136.

Hooper R. Versatile sample size calculation using simulation.Stata Journal 2013;13(1):21-38

Hooper R & Bourke L. The dog-leg: an alternative to a cross-over design for pragmatic clinical trials in relatively stable populations. Int J Epidemiol 2014;43(3):930-936.

Kahan BC. Accounting for centre-effects in multicentre trials with a binary outcome - when, why, and how? BMC Med Res Methodol 2014;14:20.

Kahan BC, Cro S, Doré CJ, Bratton DJ, Rehal S, Maskell NA, Rahman N, Jairath V. Reducing bias in open-label trials where blinded outcome assessment is not feasible: strategies from two randomised trials. Trials 2014;15(1):456.

Kahan BC, Jairath V, Doré CJ, Morris TP. The risks and rewards of covariate adjustment in randomized trials: An assessment of 12 outcomes from 8 studies. Trials 2014;15(1):139.

Morris TP, Kahan BC & White IR. Choosing sensitivity analyses for randomised trials: principles. BMC Med Res Methodol 2014;14:11.

Rick J, Graffy J, Knapp P, Small N, Collier DJ, Eldridge S, Kennedy A, Salisbury C, Treweek S, Torgerson D, Wallace P, Madurasinghe V, Hughes-Morley A, Bower P. Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials. Trials. 2014;15(1):407.

Weijer C, Taljaard M, Grimshaw JM, Edwards SJL, Eccles MP & Group tOEoCRTC. The Ottawa statement on the ethical design and conduct of cluster randomized trials: a short report. Research Ethics 2014;10(2):77-85.

2013

Diaz-Ordaz K, Froud R, Sheehan B & Eldridge S. A systematic review of cluster randomised trials in residential facilities for older people suggests how to improve quality. BMC Med Res Methodol 2013;13:127.

Diaz-Ordaz K, Slowther AM, Potter R & Eldridge S. Consent processes in cluster-randomised trials in residential facilities for older adults: a systematic review of reporting practices and proposed guidelines. BMJ Open 2013;3(7).

Hooper R, Diaz-Ordaz K, Takeda A & Khan K. Comparing diagnostic tests: trials in people with discordant test results. Stat Med 2013;32(14):2443-2456.

Hooper R, Froud RJ, Bremner SA, Perera R, Eldridge S. Cascade diagrams for depicting complex interventions in randomised trials. BMJ 2013;347:f6681

Kahan BC. Bias in randomised factorial trials. Stat Med 2013;32(26):4540-4549.

Kahan BC & Morris TP. Adjusting for multiple prognostic factors in the analysis of randomised trials. BMC Med Res Methodol 2013;13:99.

Kahan BC & Morris TP. Assessing potential sources of clustering in individually randomised trials. BMC Med Res Methodol 2013;13:58.

Kahan BC & Morris TP. Analysis of multicentre trials with continuous outcomes: when and how should we account for centre effects? Stat Med 2013;32(7):1136-1149.

Taljaard M, Weijer C, Grimshaw JM, Eccles MP & Group tOEoCRTC. The Ottawa Statement on the ethical design and conduct of cluster randomised trials: precis for researchers and research ethics committees. BMJ 2013;346:f2838.

2012

Choudhury Y, Hussain I, Parsons S, Rahman A, Eldridge S & Underwood M. Methodological challenges and approaches to improving response rates in population surveys in areas of extreme deprivation. Prim Health Care Res Dev 2012;13(3):211-218.

Eldridge S & Kerry S. A practical guide to cluster randomised trials in health services research. Chichester, Wiley, 2012.

Froud R, Eldridge S, Diaz Ordaz K, Marinho VC & Donner A. Quality of cluster randomized controlled trials in oral health: a systematic review of reports published between 2005 and 2009. Community Dent Oral Epidemiol 2012;40 Suppl 1:3-14.

Froud R, Underwood M & Eldridge S. Improving the reporting and interpretation of clinical trial outcomes. Br J Gen Pract 2012;62(603):e729-731.

Kahan BC & Morris TP. Reporting and analysis of trials using stratified randomisation in leading medical journals: review and reanalysis. BMJ 2012;345:e5840.

Kahan BC & Morris TP. Improper analysis of trials randomised using stratified blocks or minimisation. Stat Med 2012;31(4):328-340.

Peacock JL, Sauzet O, Ewings SM & Kerry SM. Dichotomising continuous data while retaining statistical power using a distributional approach. Stat Med 2012;31(26):3089-3103.

Reininghaus U & Priebe S. Measuring patient-reported outcomes in psychosis: conceptual and methodological review. Br J Psychiatry 2012;201(4):262-267.

Teerenstra S, Eldridge S, Graff M, de Hoop E & Borm GF. A simple sample size formula for analysis of covariance in cluster randomized trials. Stat Med 2012;31(20):2169-2178.

Weijer C, Grimshaw JM, Eccles MP, McRae AD, White A, Brehaut JC, Taljaard M & Group tOEoCRTC. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials. PLoS Med 2012;9(11):e1001346.

2011

Froud R, Eldridge S, Kovacs F, Breen A, Bolton J, Dunn K, Fritz J, Keller A, Kent P, Lauridsen HH, Ostelo R, Pincus T, van Tulder M, Vogel S & Underwood M. Reporting outcomes of back pain trials: a modified Delphi study. Eur J Pain 2011;15(10):1068-1074.

Nadeem NJ, Taylor SJ & Eldridge SM. Withdrawal of inhaled corticosteroids in individuals with COPD - a systematic review and comment on trial methodology.
Respir Res 2011;12:107.

2010

Eldridge S. Pragmatic trials in primary health care: what, when and how? Fam Pract 2010;27(6):591-592.

Lancaster GA, Campbell MJ, Eldridge S, Farrin A, Marchant M, Muller S, Perera R, Peters TJ, Prevost AT & Rait G. Trials in primary care: statistical issues in the design, conduct and evaluation of complex interventions. Stat Methods Med Res 2010;19(4):349-377.

2009

Eldridge S, Kerry S, Torgerson DJ. Bias in identifying and recruiting participants in cluster randomised trials: what can be done? BMJ. 2009 Oct 9;339:b4006

Eldridge SM, Ukoumunne OC, Carlin JB. The Intra-Cluster Correlation Coefficient in Cluster Randomized Trials: A Review of Definitions. International Statistical Review 2009, 77, 3, 378–394.

2008

Eldridge S, Ashby D, Bennett C, Wakelin M, Feder G. Internal and external validity of cluster randomised trials: systematic review of recent trials. BMJ 2008; 336(7649):876-880.

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Who we are

pctu launch Sandra Eldridge and Stefan Priebe

Directorate

Director: Sandra Eldridge (statistician)

Deputy Director and clinical lead, mental health: Stefan Priebe (psychiatrist)

Senior academic staff

Clinical lead, chronic conditions & primary care: Stephanie Taylor (GP) 

Clinic lead, surgical research: Charles Knowles (colorectal surgeon)

Clinical lead, translational research & primary care: Chris Griffiths (GP)

Clinical lead, women’s health: Khalid Khan (obstetrician)

Chair in health economics: Anita Patel

Reader in medical statistics: Sally Kerry

Senior lecturer in medical statistics: Richard Hooper

Senior lecturer in medical statistics: Gian Luca Di Tanna

Senior lecturer in clinical trials: Ayesha de Costa 

Senior managerial and administrative staff

Head of Operations: Tahera Hussain

Quality assurance manager: Anitha Manivannan

Clinical trials information systems (CTIS) manager: Arouna Woukeu

PCTU administrator: Charlotte Ayton-George 

Senior trials managers

Generic: Ann Thomson 

Translational health: Bev MacLaughlin

Surgical Unit: Tash Stevens

Women’s health: Julie Dodds

The unit also has statisticians, health economists, database programmers, monitors and administrators who each work across a number of projects, and trial managers, trial coordinators, data assistants, research nurses who usually focus on individual projects. 

Staff role definitions

We want to ensure researchers get the best possible support from the Pragmatic Clinical Trials Unit and know who is responsible for which tasks within the unit. Different clinical trials units operate differently so this guide applies specifically to the Pragmatic Clinical Trials Unit.

Please see below outlines of some of the roles individuals can play within a trial. You may wish to refer to this guide in combination with the support services available when requesting PCTU support. Staff listed below are employed by the PCTU. Funding for their roles is incorporated in research grant applications, and for successful grants this funding is then paid by the organisation that receives the grant direct to the PCTU to pay these staff.

Data Manager

PCTU data managers: Tom Power, Mike Waring

We offer database design appropriate to the individual needs of each project we support. The data manager will develop appropriate data management strategies for trials and advise on their implementation. They will advise on current regulatory framework regarding data protection and data management procedures in compliance with data protection act and other regulations.
The data manager will advise on suitable database for individual study and set up databases in liaison with chief investigators, statisticians and health economists working on trials. Each database will have integrated data validation checks and full audit trails. Clinical and patient identifiable data are kept on physically separate databases. The data manager will advise on and set up data transfer systems and encryption systems so that all patient identifiable data is encrypted. The data manager will also advise on storage, back-up and archiving of data to ensure databases are regularly backed up to ensure data are safeguarded from accidental loss. In addition to this data management covers the following tasks:Advise on case report form (CRF) design

  • Agree with chief investigator time line for database set up and database lock
  • With chief investigator, draw up trial data management SOPs.

Health Economist

PCTU health economist: Natalia Hounsome

In some clinical trials, it can be important to compare how much different treatments cost, as well as how well they work. This can be particularly important when two (or more) treatments are equally effective, but differ considerably in their costs. An economic evaluation as offered by our health economist will ensure that all costs (treatment, care and recovery, as well as the costs of prevention, research and training of healthcare personnel) have been considered when the trial results are presented.
The health economist will:

  • Develop plans for economic analyses and advise on appropriate data collection
  • Collaborate with statisticians and data managers working on trials to ensure appropriate data management systems
  • Carry out economic analyses for trials including modelling
  • Input into report and publication papers.

Quality Assurance Officer

PCTU QA managers: Anitha Manivannan

The quality assurance officer will train trial staff in PCTU and Joint Research Office's Standard Operating Procedures (SOPs) as relevant to their work, liaise with chief investigators regarding set up trial master files and carry out audits of the trial master file for ongoing quality assurance. They will also ensure compliance with GCP regulations and advise on staff GCP requirements, clinical trial regulatory requirements, adverse event reporting and on PCTU support available.

PCTU Head of Operations

PCTU Head of Operations: Tahera Hussain

The PCTU Head of Operations will act on behalf of the unit director and negotiate with chief investigators over PCTU involvement in trial, agreeing costs and timing. The Head of Operations will liaise with the Joint Research Office over costings for PCTU staff and with grant holding organisation regarding transfer of funds for PCTU support. They manage the PCTU budget and also liaise with R&D departments to ensure necessary contracts are in place.

PCTU Administrator

PCTU administrator: currently vacant

The administrator acts as first point of contact for researchers wishing to collaborate with the PCTU. Day to day admin within the unit covers tasks such as:

  • Filter enquiries to the unit, liaising with unit staff as necessary
  • Maintain records of all agreements between CIs and PCTU
  • Maintain database logging PCTU activity
  • Maintain database of active and completed projects supported
  • Administrative support for supported projects includes design and maintenance of trial websites for all supported projects.

Further administrative support can be arranged (mainly for trials led from within the Centre for Primary Care and Public Health) to include for example trial correspondence, liaising with research staff or setting up site files as required.

Statistician

PCTU statisticians: Lauren Bell; Lee Beresford; Claire Coleman; Gordon Forbes; Lauren Greenberg; Brennan Kahan; Vichithranie Madurasinghe; Nadine Marlin; Claire Nightingale; Neil Wright

Statistical support is required at all stages of a project starting with input into protocol development. Further support includes developing analysis plans, performing randomisation or minimisation for trials, liaising with health economist and data managers working on trials, or other studies under the remit of the PCTU, to ensure appropriate data management systems are in place and of course carrying out statistical analyses. Other tasks performed by the statisticians are:

  • Carry out sample size/power calculations
  • Input into CRF/data capture tools development
  • Write detailed statistical analysis plans
  • Liaise with data manager to ensure adequate cleaning of final dataset
  • Write and check Stata .do files or other appropriate programmes to perform data manipulation and analysis
  • Produce reports for the Data Monitoring Committee, Trial Steering Committee or funder as necessary
  • Perform any pre-planned interim analysis blinded to treatment allocation. If unblinded analysis is necessary, such analysis will be performed by another statistician in the PCTU.
  • Attend trial/study team meetings where possible
  • Liaise with data manager and trial manager throughout the duration of the trial to ensure data quality and integrity
  • Write a final statistical report
  • Authorship on publications arising from projects
  • Respond to publication reviewers' comments.

Trial coordinator / Trial manager Post it note - Urgent

PCTU trial managers and coordinators: John Allotey; Sybil Bannister; Lesley Dibley; Julie Dodds; Jessica Gavira; Eion Golden; Wai Yee James; Paula John; Doris Lanz; Bev MacLaughlin; Jacqueline Mansfield; Katie Myers-Smith; Sian Newton; Hana Pavlickova; Sarrah Peerbux; Anna Placzek; Ewelina Rogozinska; Irene Simmonds; Sarah Snuggs; Natasha Stevens; Shiva Taheri; Ann Thomson; Jenn Walker; Karolina Witt

The trial coordinator or manager will maintain general oversight of trial coordinating participating sites as necessary over the full duration of the project. They also manage the trial administration by ensuring that files and documentation is up to date and complete, by keeping accurate written and computerised secure and safe records. They will ensure that all clinical trials procedures are fully compliant with the PCTU's and sponsor's standard operating procedures as applicable to the trial.
They will act as the point of contact for all external and internal agencies and provide efficient day-to-day management of the trial.
This includes but is not limited to:

  • Maintain confidentiality and security of patient and staff records
  • Recruitment, retention, training, appraisal and supervision of trial team members.
  • Establish procedures to ensure adherence to trial protocols and administrative requirements
  • Ensure the timely recruitment of trial participants with secure randomisation processes and subsequent efficient and effective data management
  • Monitor the trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems
  • Manage the trial budget(s) and maintain the accounts
  • Coordinate the preparation and publication of data, reports and information, ensuring that these meet legislative, contractual and ethical requirements
  • Liaise with the Trials Steering Committee and Data Monitoring and Ethics Committee with a particular view on compliance with Research Governance, Good Clinical Practice, Data Protection and Ethical Requirements
  • Provide regular and ad hoc information, both written and verbal, to all the trial participants, funders and sponsors. This could include reports, updates, guidance, proformed commitments and, possibly, a Newsletter.
  • Work with the Chief Investigator to ensure that the trial is meeting its targets, is producing meaningful output and to predict and plan any changes that warrant requests to changes in protocol, funding or time
  • Ensure the inclusion of patient representatives at the appropriate levels and times
  • Plan and support meetings and work of the various groups and bodies associated with the trial.

The trial coordinator will also have access to additional advice and assistance from the PCTU's senior trial manager as well as the quality assurance officer. This will be particularly relevant at approval stage, when liaising with various external agencies to gain the appropriate approvals for the project, and in the event of any non-compliance or serious adverse events.

Writing with pencilTrial monitor

PCTU trial monitor: Jeanette Hansen

PCTU will monitor and/or audit PCTU supported CTIMP and non-CTIMP trials on a risk-based basis as agreed by the sponsor. The monitoring plan will be agreed by the CI, sponsor and PCTU QA manager prior to study initiation.
Tasks performed by the monitor are:

  • Source data verification
  • Monitor progress of trial
  • Confirm that all adverse events are being documented and reported as necessary
  • Check CI adheres to their responsibilities according to GCP and delegates responsibilities appropriately
  • Scrutinize trial related documents
  • Examine research staff on their knowledge of the protocol
  • Ensure that the trial is being conducted according to GCP, clinical trial regulations and sponsor requirements.
  • The purpose is to verify that reported trial data is correct, complete and verifiable (ICH GCP 1.38 and 5.18.1). Findings are reported to the PCTU QA manager and sponsor via a monitoring report.

Support

What PCTU does

What is a clinical trial?

We use the definition of a clinical trial as proposed by the International Committee of Medical journal editors: Question mark

"Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome. By 'medical intervention' we mean any intervention used to modify a health outcome. This definition includes drugs, surgical procedures, devices, behavioural treatments, process-of-care changes, and the like."

This definition is wider than other definitions, some of which restrict the use of the word 'clinical' to trials in which medicinal products are being investigated. Many of the trials the PCTU leads and supports are not trials of investigational medicinal products.

What is an investigational medicinal product (IMP)?

Article 2 (d) of the EU Clinical Trials Directive 2001/20/EC provides the following definition for an IMP:

"a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form."

The PCTU does lead and support trials of investigational medicinal products but these are in the minority.

Trials led by the unit

The unit leads trials conducted within the Centre for Primary Care and Public Health and the Centre for Psychiatry.

Trials linked to the unit

These include trials led from elsewhere in Barts and The London School of Medicine and Dentistry or Barts Health NHS Trust, and trials led from outside these organisations. The last category includes multi-centre trials led from other centres, where the unit may sometimes have joint responsibility for aspects of trial design and analysis together with another clinical trials unit. Trials from outside the Centres of Primary Care and Public Health and Psychiatry can be linked to the unit if they are trials of effectiveness fitting broadly with either the research strategies or methodological interests of the unit.

How to obtain support

Initial request Lady on laptop

An initial request for support must be logged with the This email address is being protected from spambots. You need JavaScript enabled to view it., usually via a short e-mail. We will carefully assess our engagement in a trial on the basis that the trial should enhance and confirm our reputation as delivering high quality, clinically relevant, methodologically excellent RCTs. An initial decision about the suitability of the trial for support by the unit will then be made. If the trial appears eligible for support the level of support can be discussed.

The initial request has to be received at least 12 weeks before the intended application's submission date (outline application if applicable).

Level of support

Usually, the PCTU would expect to provide all the services listed under details of support available, dependant on the potential costs for support and the capacity of the PCTU. In some cases the level of support will depend on the costs involved and the capacity of the PCTU. We are able to offer bespoke advice tailored to the individual needs of each supported project but will only engage in high quality, methodologically sound trials where we also have academic input. All trials supported by the PCTU must adhere to relevant Standard Operating Procedures already in place.

Approval

Once the trial chief investigator and the PCTU manager are in agreement about the level of support and costs, approval for support must be gained in writing (usually by email) from the PCTU director or manager. This approval must be gained before any funding applications are submitted and must include full details of the support and cost agreed upon.

Support available

Support can be accessed during protocol development and during the trial itself. Support accessed during protocol development is not charged for and must be negotiated depending on PCTU capacity. This support is important in relation both to successful funding and successful projects and we encourage all researchers to take full advantage of the support offered this stage.
We often encourage researchers to also link with the London Research Design Service for further support in developing their application.

Services accessed after trial funding is secured must all be adequately costed and agreed beforehand. We will expect to recover the true costs of our engagement in a study in terms of staff costs and consumables.

Such funding supports staff employed by the unit to work across a range of trials, such as data managers, statisticians, health economists, quality assurance officers, administrators and the unit manager.

Areas in which the unit supports trial are:

In protocol development

- Statistical advice prior to submission

  • Advice about sample size calculation
  • Advice about statistical analysis plan in protocol development
  • Advice about trial design

- Other field specific advice about:

  • health economics analysis
  • data management
  • quality assurance

At Set up and during trial problems and solutions

- Randomisation service

- Statistical Services

  • Statistical analysis planning
  • Statistical advice and analysis
  • Contribution to report writing

- Data Management

  • Data management advice
  • Database set-up

- Quality Assurance

  • Advice on adverse event reporting
  • Advice on clinical trial regulatory requirements and quality assurance
  • Access to and advice about CTU endorsed SOPs

- Health Economic Services

  • Economic evaluation
  • Contribution to report writing Brain storm for solutions

- Administrative support

- Senior Statistician advice and presence on steering committees

- Senior Health Economist advice and presence on steering committees

- Senior trial management advice

- Trial coordinator support

- Trial monitoring

The unit does not provide advice that can be accessed elsewhere. For trials led from Barts and The London School of Medicine and Dentistry, detailed advice about research governance, ethical approval and MHRA procedures please see Joint Research Management Office (JRMO) of Barts Health NHS Trust and Queen Mary, University of London.

SOPs & CI responsibilities

CI responsibilities

The chief investigator is responsible for negotiating level and cost of support and for gaining approval for support by the PCTU (as specified in PCTU support), and for clearly specifying the role of the PCTU and corresponding financial implications in any funding application. GP at EPP course

The PCTU works to a number of SOPs specific to the PCTU. The chief investigator is responsible for ensuring that trials linked to the PCTU follow these SOPs. Compliance will be monitored by the PCTU. The responsibilities of the chief investigator as detailed in the ICH Good Clinical Practice guidelines are listed below:

    1. Qualifications and agreements (GCP, delegation of trial-related duties)
    2. Adequate Resources – time, funding, demonstrate ability to recruit (via pilot etc)
    3. Medical care of trial subjects
    4. On-going communication with REC/MHRA throughout trial (amendments, annual reports etc)
    5. Ensure full compliance with protocol and document deviations and submit amendments to REC
    6. Investigational Product (if applicable) - responsible for IMP accountability at site/s (can be assigned to appropriate pharmacist)
    7. Randomization Procedures and Unblinding – responsible for following trial's randomization and blinding/unblinding procedures (if applicable)
    8. Informed consent – responsible for following GCP guidelines on informed consent
    9. Records and Reports – follow GCP guidelines on CRF and source documentation, maintenance of trial documentation, financial agreements and archiving
    10. Progress Reports – provide written summaries to REC (annually or more frequently if requested) and sponsor and REC regarding substantial changes to trial
    11. SAEs - responsible for ensuring all SAEs reported to sponsor (‘Sponsor’ is an individual, company, institution or organisation which takes responsibility for the initiation and management of the clinical trial)
    12. Premature Termination or Suspension of Trial – Responsible for ensuring trial subjects, institution sponsor and REC are promptly informed if trial ends prematurely or is suspended
    13. Final Report – ensure that final report provided to institution, REC, regulatory authorities and sponsor

Standard Operating Procedures

All PCTU SOPs listed on the PCTU website have been reviewed and authorised by the PCTU director. Access to the SOPs is available on request. If you would like a copy of any of the SOPs listed then please email This email address is being protected from spambots. You need JavaScript enabled to view it.

  • PCTU SOP DM 02 CRF Design v2.0
  • PCTU SOP DM 04 Data Entry, Quality Control, Data Extraction and Database lock v2.0
  • PCTU SOP DM 05 Electronic Data Security v3.0
  • PCTU SOP DM 06 eCRF-Database Application Design and Development v2.0
  • PCTU SOP DM 07 Database Validation v2.0
  • PCTU SOP DM 08 Database Application Versioning and Change Control v2.0
  • PCTU SOP DM 09 Business continuity - Backup and disaster recovery v2.0
  • PCTU SOP DM 10 Database Application Documentation v2.0
  • PCTU SOP DM 11 Data Transfer v2.0
  • PCTU SOP GA 01 PCTU Trial  Support Proceedure (for CIs) v5.0
  • PCTU SOP GA 02 PCTU Filtering System for Trial Support Enquiries (PCTU Staff) v5.0
  • PCTU SOP GA 03 Event Organising v3.0
  • PCTU SOP GA 04 Agreement between PCTU and JRMO regarding costing of PCTU v2.0
  • PCTU_SOP_HE 01 Health Economics Analysis v3.0
  • PCTU_SOP_IT 01 Clinical Trials Systems Access v2.0
  • EPP course participants listening to GP
  • PCTU SOP QA 01 Pragmatic CTU SOPs v4.0
  • PCTU SOP QA 02 QA and QC System v6.0
  • PCTU SOP QA 03 Document Control v5.0
  • PCTU SOP QA 04 Monitoring of PCTU Supported Research Projects v2.0
  • PCTU SOP QA 05  Statistical and Health Economic Analysis QC v2.0
  • PCTU SOP QA 06  Staff Training v3.0
  • PCTU SOP QA 07 Preparing for regulatory inspections v1.0
  • PCTU SOP SP 01 Statistical Analysis v4.0
  • PCTU SOP TC 01 Trial Close Out v2.0
  • PCTU SOP TC 02 Archiving Research Projects v3.0
  • PCTU SOP TM 01 Trial Master File and Investigator Site file maintenance v6.0
  • PCTU SOP TM 02 External Trial Oversight Committees v3.0
  • PCTU SOP TM 03 IMP management and labelling v4.0
  • PCTU SOP TM 04 Informed Consent v2
  • PCTU SOP TM 05 Adverse Event Reporting for CTIMPs v2.0
  • PCTU SOP TM 06 Adverse Event Reporting for non-CTIMPs v2.0
  • PCTU SOP TM 07 Document Completion, Transport and Storage v2.0
  • PCTU SOP TM 08 Reporting of Amendments and Deviations v2.0
  • PCTU SOP TM 09 Site Initiation and Staff Training v3.0
  • PCTU SOP TM 10 Handling Trial Correspondence v2.0
  • PCTU SOP TM 11 Effective Trial Management v3.0
  • PCTU SOP TM 12 Annual progress, safety and end of trial reports v3.0

  • PCTU SOP TP 01 Protocol development v4.0
  • PCTU SOP TP 02 Statistician Involvement v5.0
  • PCTU SOP TP 03 Randomisation and blinding v5.0
  • PCTU SOP TP 04 Clinical Trial Risk Assessment v2.0
  • PCTU SOP TP 05 Trial Management - The Approval Processt v2.0

Contact

Pragmatic Clinical Trials Unit
c/o Centre for Primary Care and Public Health  
Yvonne Carter Building
58 Turner Street
Whitechapel, London E1 2AB

Telephone: + 44 (0)20 7882 3449
Facsimile: + 44 (0)20 7882 2552

Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Please note the PCTU does not recruit trial participants. If you wish to participate in any of the trials we support please contact the trial team directly. For contact details see trial information in our research section.

News & Events

Training Courses

Inside a Clinical Trials Unit

This course will be of interest to new principal investigators and other researchers who have not previously worked closely with a Clinical Trials Unit (CTU), and who want to learn more about the design and conduct of pragmatic clinical trials and the nature of CTU involvement. The course is an immersive experience including observation of real-life trial processes and the work of CTU staff, and one-to-one time spent with knowledgeable tutors.

Registration on one of our 3-day taught courses (Introduction to Design, Conduct and Analysis of Pragmatic Clinical Trials, or A Practical Guide to Cluster Randomised Trials (Introductory Course)) is also included in the price. The course will be based at the Pragmatic Clinical Trials Unit (PCTU) at Barts & The London School of Medicine & Dentistry.

In addition to the 3-day taught course, the total time commitment amounts to no more than 1 hour a week, spread over a period up to one year, though this can be scheduled flexibly to suit your needs. You will benefit from:

  • a lead tutor who will be your main point of contact with PCTU, who will help you to plan a series of opportunities (at least 10 hours in total) for observing meetings and other PCTU activities encompassing the complete natural history of a trial;
  • 6 one-to-one 1-hour sessions with your lead tutor, spread over the year, to consolidate what you have learned and discuss issues in depth;
  • 6 one-to-one 1-hour sessions, spread over the year, with a specialist tutor from one of four PCTU teams (depending on the area you particularly want to focus on): statistics, data management, quality assurance or trial management.

Some of your time will be devoted to self-directed learning: your lead tutor will give you resources and practical tasks suited to your study programme, and there will be space in PCTU for hot-desking and engaging more fully with the Unit. 

                                                              

REGISTRATION

You can start the course at any time during the year, but the number of places at any one time is very limited, and you will need to give us at least 1 month’s notice of your intended start date, so we advise that you contact us as early as possible if you are interested in joining.

Cost for those booking before end of June 2016:

QMUL staff: £2,500

External: £2,800

CONTACT (also for information about our 3-day taught courses, including dates)

Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Websitehttp://www.blizard.qmul.ac.uk/pragmatic-clinical-trials-unit.html#news-events 


Current developments in cluster randomised trials and stepped wedge designs

This meeting will consist of a series of short talks and discussion about new perspectives for the design, the analysis and the reporting of cluster and stepped wedge trials.

If you would like to give one of the talks please send an abstract of 300 words [plus title, authors, contact details and affiliation for presenting author to This email address is being protected from spambots. You need JavaScript enabled to view it. by July 29th 2016

We will reply with decisions regarding abstracts by Sept 29th 2016.

 

Location

Old Library at Queen Mary University

Dates

29th November 2016: 10:30am-4pm

Registration

Link for online registration and payment:

http://eshop.qmul.ac.uk/browse/extra_info.asp?compid=1&modid=2&deptid=34&catid=1&prodid=636

Registration ends: 14thNovember 2016

Cost: £25 includes Lunch

Contact for delegates Pragmatic Clinical Trials Unit Tel: +44 (0)20 7882 6306  This email address is being protected from spambots. You need JavaScript enabled to view it.

Website

http://www.blizard.qmul.ac.uk/pragmatic-clinical-trials-unit.html#news-events

 


Pragmatic Clinical Trials Unit

PCTU Newsletter

Issue 5 - July 2015

Issue 4 - October 2014

Issue 3 - May 2014

Issue 2 - February 2014

Issue 1 - November 2013

30 June 2015 - Prof Sandra Eldridge awarded Honorary Fellowship of Royal College of General Practitioners

12 July 2013 - Publication checklist proposed to boost rigor of pilot trials

 

Eldridge Kerry book coverA Practical Guide to Cluster Randomised Trials in Health Services Research

Sandra Eldridge and Sally Kerry have published a book 'A Practical Guide to Cluster Randomised Trials in Health Services Research' with Wiley & Sons Ltd. The book provides a concise guide to running cluster randomised trials in a health care setting; covering ethics, recruitment, piloting, design, reporting, systematic reviews, process evaluations and monitoring with introductions to analysis, sample size calculations, and health economics. The book is available to purchase from Wiley.