Skip to main content
Article thumbnail
Location of Repository

Recruitment to randomised trials : Strategies for Trial Enrolment and Participation Study. The STEPS study

By Marion Kay Campbell, Alison Mary McDonald, Vikki Entwistle, Adrian Maxwell Grant, STEPS Group, Claire Snowdon, David Francis, Diana R. Elbourne, Rosemary C. Knight, Jo Garcia and Ian Roberts

Abstract

Objectives: To identify factors associated with good and poor recruitment to multicentre trials.\ud Data sources: Part A: database of trials started in or after 1994 and were due to end before 2003 held by the Medical Research Council and Health Technology Assessment Programmes. Part B: interviews with people playing a wide range of roles within four trials that their funders identified as ‘exemplars’. Part C: a large multicentre trial (the CRASH trial) of treatment for head injury.\ud Review methods: The study used a number of different perspectives (‘multiple lenses’), and three components. Part A: an epidemiological review of a cohort of trials. Part B: case studies of trials that appeared to have particularly interesting lessons for recruitment. Part C: a single, in-depth case study to examine the feasibility of applying a businessorientated analytical framework as a reference model in future trials.\ud Results: In the 114 trials found in Part A, less than one-third recruited their original target within the time originally specified, and around one-third had extensions. Factors observed more often in trials that recruited successfully were: having a dedicated trial manager, being a cancer or drug trial, and having interventions only available inside the trial. The most commonly reported strategies to improve recruitment were newsletters and mailshots, but it was not possible to assess whether they were causally linked to changes in recruitment. The analyses in Part B suggested that successful trials were those addressing clinically important questions at a timely point. The investigators were held in high esteem by the interviewees, and the trials were firmly grounded in existing clinical practices, so that the trial processes were not alien to clinical collaborators, and the results could be easily applicable to future practice. The interviewees considered that the needs of patients were well served by participation in the trials. Clinical collaborators particularly appreciated clear delineation of roles, which released them from much of the workload associated with trial participation. There was a strong feeling from interviewees that they were proud to be part of a successful team. This pride fed into further success. Good groundwork and excellent communications across many levels of complex trial structures were considered to be extremely important, including training components for learning about trial interventions and processes, and team building. All four trials had faced recruitment problems, and extra insights into the working of trials were afforded by strategies invoked to address them. The process of the case study in Part C was able to draw attention to a body of research and practice in a different discipline (academic business studies). It generated a reference model derived from a combination of business theory and work within CRASH. This enabled identification of weaker managerial components within CRASH, and initiatives to strengthen them. Although it is not clear, even within CRASH, whether the initiatives that follow from developing and applying the model will be effective in increasing recruitment or other aspects of the success of the trial, the reference model could provide a template, with potential for those managing other trials to use or adapt it, especially at foundation stages. The model derived from this project could also be used as a diagnostic tool if trials have difficulties and hence as a basis for deciding what type of remedial action to take. It may also be useful for auditing the progress of trials, such as during external review.\ud Conclusions: While not producing sufficiently definitive results to make strong recommendations, the work here suggests that future trials should consider the different needs at different phases in the life of trials, and place greater emphasis on ‘conduct’ (the process of actually doing trials). This implies learning lessons from successful trialists and trial managers, with better training for issues relating to trial conduct. The complexity of large trials means that unanticipated difficulties are highly likely at some time in every trial. Part B suggested that successful trials were those flexible and robust enough to adapt to unexpected issues. Arguably, the trialists should also expect agility from funders within a proactive approach to monitoring ongoing trials. Further research into different recruitment patterns (including ‘failures’) may help to clarify whether the patterns seen in the ‘exemplar’ trials differ or are similar. The reference model from Part C needs to be further considered in other similar and different trials to assess its robustness. These and other strategies aimed at increasing recruitment and making trials more successful need to be formally evaluated for their effectiveness in a range of trials.Not peer reviewedPublisher PD

Topics: Randomized Controlled Trials, Research Design, Patient Participation, RA Public aspects of medicine
Publisher: Gray Publishing
Year: 2007
DOI identifier: 10.3310/hta11480
OAI identifier: oai:aura.abdn.ac.uk:2164/179
Journal:
Download PDF:
Sorry, we are unable to provide the full text but you may find it at the following location(s):
  • http://hdl.handle.net/2164/179 (external link)
  • http://dx.doi.org/10.3310/hta1... (external link)
  • http://www.ncchta.org/fullmono... (external link)
  • Suggested articles

    Citations

    1. (2001). 1 Clinical and cost-effectiveness of donepezil, rivastigmine and galantamine for Alzheimer’s disease: a rapid and systematic
    2. (2007). 19 Clinical effectiveness and costeffectiveness of growth hormone in adults in relation to impact on quality of life: a systematic review and economic
    3. (2007). 4 A systematic review of the effectiveness and cost-effectiveness of neuroimaging assessments used to visualise the seizure focus in people with refractory epilepsy being considered for surgery. By Whiting
    4. (2007). 5 A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines. By
    5. (1998). A review by
    6. (2002). A study of the methods used to select review criteria for clinical audit. By Hearnshaw
    7. (2007). All rights reserved.
    8. (2007). All rights reserved. No. 34 A systematic review of comparisons of effect sizes derived from randomised and non-randomised studies. By MacLehose
    9. (2007). All rights reserved. Volume 9,
    10. Assessm ent 2007;Vol. 11: N o. 48 Recruitm ent to random ised trials: strategies for trial enrolm ent and participation study
    11. (2007). Assessment Programme Diagnostic Technologies & Screening Panel Members Chair, Dr Ron Zimmern, Director of the Public Health Genetics Unit, Strangeways Research Laboratories, Cambridge Ms Norma Armston, Freelance Consumer Advocate,
    12. authors would like to know your views about this report.
    13. (1999). Barriers to participation in randomised controlled trials: a systematic review.
    14. (2003). How important are comprehensive literature searches and the assessment of trial quality in systematic reviews? Empirical
    15. (2007). No. 1 Pemetrexed disodium for the treatment of malignant pleural mesothelioma: a systematic review and economic evaluation. By Dundar
    16. (2006). No. 1 The clinical and cost-effectiveness of donepezil, rivastigmine, galantamine and memantine for Alzheimer’s disease. By Loveman E,
    17. (2007). The website also provides information about the HTA Programme and lists the membership of the various committees. HTA Recruitment to randomised trials: strategies for trial enrolment and participation study. The STEPS study MK
    18. (2004). What is the best imaging strategy for acute stroke? By

    To submit an update or takedown request for this paper, please submit an Update/Correction/Removal Request.