29,201 research outputs found
Managing clinical trials.
No full textManaging clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field. For the past three decades, trialists have invented and reinvented the trial management wheel. We suggest that to improve the successful, timely delivery of important clinical trials for patient benefit, it is time to produce standard trial management guidelines and develop robust methods of evaluation
What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies.
No full textNational Coordinating Centre for Research Methodology; Medical Research Council, UK Department of Health; Chief Scientist OfficeNot peer reviewedPublisher PDFTex
Marketing and clinical trials : a case study
No full textBackground: Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods: Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results: The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion: The performance of future clinical trials could be enhanced if trialists routinely considered these factors.We would like to thank the National Co-ordinating Centre for Research Methodology for commissioning this research; the MRC and the DH for providing funding; and the CRASH trial team. The Health Services Research Unit is funded by the Chief Scientist Office of the Scottish Executive Health Department. The views expressed are not necessarily those of the funders and the funders had no involvement in the study.Peer reviewedPublisher PD
Financial considerations in the conduct of multi-centre randomised controlled trials: evidence from a qualitative study.
No full textNational Coordinating Centre for Research Methodology; Medical Research Council, UK Department of Health; Chief Scientist OfficeNot peer reviewedPublisher PD
Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials
No full textBackground Randomized controlled trials play a central role in evidence-based practice, but recruitment of participants, and retention of them once in the trial, is challenging. Moreover, there is a dearth of evidence that research teams can use to inform the development of their recruitment and retention strategies. As with other healthcare initiatives, the fairest test of the effectiveness of a recruitment strategy is a trial comparing alternatives, which for recruitment would mean embedding a recruitment trial within an ongoing host trial. Systematic reviews indicate that such studies are rare. Embedded trials are largely delivered in an ad hoc way, with interventions almost always developed in isolation and tested in the context of a single host trial, limiting their ability to contribute to a body of evidence with regard to a single recruitment intervention and to researchers working in different contexts. Methods The Systematic Techniques for Assisting Recruitment to Trials (START) program is funded by the United Kingdom Medical Research Council (MRC) Methodology Research Programme to support the routine adoption of embedded trials to test standardized recruitment interventions across ongoing host trials. To achieve this aim, the program involves three interrelated work packages: (1) methodology - to develop guidelines for the design, analysis and reporting of embedded recruitment studies; (2) interventions - to develop effective and useful recruitment interventions; and (3) implementation - to recruit host trials and test interventions through embedded studies. Discussion Successful completion of the START program will provide a model for a platform for the wider trials community to use to evaluate recruitment interventions or, potentially, other types of intervention linked to trial conduct. It will also increase the evidence base for two types of recruitment intervention. Trial registration: The START protocol covers the methodology for embedded trials. Each embedded trial is registered separately or as a substudy of the host trial
A systematic review of models to predict recruitment to multicentre clinical trials
No full textAbstract Background Less than one third of publicly funded trials managed to recruit according to their original plan often resulting in request for additional funding and/or time extensions. The aim was to identify models which might be useful to a major public funder of randomised controlled trials when estimating likely time requirements for recruiting trial participants. The requirements of a useful model were identified as usability, based on experience, able to reflect time trends, accounting for centre recruitment and contribution to a commissioning decision. Methods A systematic review of English language articles using MEDLINE and EMBASE. Search terms included: randomised controlled trial, patient, accrual, predict, enrol, models, statistical; Bayes Theorem; Decision Theory; Monte Carlo Method and Poisson. Only studies discussing prediction of recruitment to trials using a modelling approach were included. Information was extracted from articles by one author, and checked by a second, using a pre-defined form. Results Out of 326 identified abstracts, only 8 met all the inclusion criteria. Of these 8 studies examined, there are five major classes of model discussed: the unconditional model, the conditional model, the Poisson model, Bayesian models and Monte Carlo simulation of Markov models. None of these meet all the pre-identified needs of the funder. Conclusions To meet the needs of a number of research programmes, a new model is required as a matter of importance. Any model chosen should be validated against both retrospective and prospective data, to ensure the predictions it gives are superior to those currently used.</p
Can simply answering research questions change behaviour? Systematic review and meta analyses of brief alcohol intervention trials.
No full textBACKGROUND: Participant reports of their own behaviour are critical for the provision and evaluation of behavioural interventions. Recent developments in brief alcohol intervention trials provide an opportunity to evaluate longstanding concerns that answering questions on behaviour as part of research assessments may inadvertently influence it and produce bias. The study objective was to evaluate the size and nature of effects observed in randomized manipulations of the effects of answering questions on drinking behaviour in brief intervention trials. METHODOLOGY/PRINCIPAL FINDINGS: Multiple methods were used to identify primary studies. Between-group differences in total weekly alcohol consumption, quantity per drinking day and AUDIT scores were evaluated in random effects meta-analyses. Ten trials were included in this review, of which two did not provide findings for quantitative study, in which three outcomes were evaluated. Between-group differences were of the magnitude of 13.7 (-0.17 to 27.6) grams of alcohol per week (approximately 1.5 U.K. units or 1 standard U.S. drink) and 1 point (0.1 to 1.9) in AUDIT score. There was no difference in quantity per drinking day. CONCLUSIONS/SIGNIFICANCE: Answering questions on drinking in brief intervention trials appears to alter subsequent self-reported behaviour. This potentially generates bias by exposing non-intervention control groups to an integral component of the intervention. The effects of brief alcohol interventions may thus have been consistently under-estimated. These findings are relevant to evaluations of any interventions to alter behaviours which involve participant self-report
A systematic review of randomised controlled trials of interventions promoting effective condom use.
No full textBACKGROUND: Effective condom use can prevent sexually transmitted infections (STIs) and unwanted pregnancy. We conducted a systematic review and methodological appraisal of randomised controlled trials (RCTs) of interventions to promote effective condom use. METHODS: We searched for all RCTs of interventions to promote effective condom use using the Cochrane Infectious Diseases Group's trials register (Oct 2006), CENTRAL (Issue 4, 2006), MEDLINE (1966 to Oct 2006), EMBASE (1974 to Oct 2006), LILACS (1982 to Oct 2006), IBSS (1951 to Oct 2006) and Psychinfo (1996 to Oct 2006). We extracted data on allocation sequence, allocation concealment, blinding, loss to follow-up and measures of effect. Effect estimates were calculated. RESULTS: We identified 139 trials. Seven out of ten trials reported reductions in 'any STI' with five statistically significant results. Three out of four trials reported reductions in pregnancy, although none was statistically significant. Only four trials met all the quality criteria. Trials reported a median of 11 (IQR 7-17) outcome measures. Few trials used the same outcome measure. Altogether, 10 trials (7%) used the outcome 'any STI', 4 (3%) self-reported pregnancy and 22 (16%) used 'condom use at last sex'. CONCLUSIONS: The results are generally consistent with modest benefits but there is considerable potential for bias due to poor trial quality. Because of the low proportion of trials using the same outcome the potential for bias from selective reporting of outcomes is considerable. Despite the public health importance of increasing condom use there is little reliable evidence on the effectiveness of condom promotion interventions
Does a monetary incentive improve the response to a postal questionnaire in a randomised controlled trial? : the MINT incentive study
No full textBackground: Sending a monetary incentive with postal questionnaires has been found to improve
the proportion of responders, in research in non-healthcare settings. However, there is little
research on use of incentives to improve follow-up rates in clinical trials, and existing studies are
inconclusive. We conducted a randomised trial among participants in the Managing Injuries of the
Neck Trial (MINT) to investigate the effects on the proportion of questionnaires returned and
overall non-response of sending a £5 gift voucher with a follow-up questionnaire.
Methods: Participants in MINT were randomised to receive either: (a) a £5 gift voucher (incentive
group) or (b) no gift voucher (no incentive group), with their 4 month or 8 month follow-up
questionnaire. We recorded, for each group, the number of questionnaires returned, the number
returned without any chasing from the study office, the overall number of non-responders (after
all chasing efforts by the study office), and the costs of following up each group.
Results: 2144 participants were randomised, 1070 to the incentive group and 1074 to the no
incentive group. The proportion of questionnaires returned (RR 1.10 (95% CI 1.05, 1.16)) and the
proportion returned without chasing (RR 1.14 (95% CI 1.05, 1.24) were higher in the incentive
group, and the overall non-response rate was lower (RR 0.68 (95% CI 0.53, 0.87)). Adjustment for
injury severity and hospital of recruitment to MINT made no difference to these results, and there
were no differences in results between the 4-month and 8-month follow up questionnaires.
Analysis of costs suggested a cost of £67.29 per additional questionnaire returned.
Conclusion: Monetary incentives may be an effective way to increase the proportion of postal
questionnaires returned and minimise loss to follow-up in clinical trials
Coping with Persistent Pain, Effectiveness Research into Self-management (COPERS): statistical analysis plan for a randomised controlled trial
No full textThis is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated
- …
