Recruitment to randomised trials: strategies for trial enrolment and participation study. The STEPS study
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Objectives To identify factors associated with good and poor recruitment to multicentre trials. 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. 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 business-orientated analytical framework as a reference model in future trials. 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…
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Difficulties in recruitment are common in clinical trials.
“However, difficulties in recruitment are common in clinical trials.309 310”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [309]
Different recruitment methods can substantially affect the number and type of trial participants recruited and can incur different costs.
“Different recruitment methods can substantially affect the number and type of trial participants recruited206 309 312 313 and can incur different costs.314 315 316”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [309]
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Dobra, R., Wilson, G., Matthews, J., Boeri, M., Elborn, S., Kee, F., Davies, J. C., & Madge, S. (2023) · JRSM Open · doi:10.1177/20542704231166621 · Cited by 13 · see citing works
- Authors
- Campbell, M., Snowdon, C., Francis, D., Elbourne, D., McDonald, A., Knight, R., Entwistle, V, Garcia, J., Roberts, I., Grant, A., & Grant, A.
- Affiliations
- University of Aberdeen (GB)
- London School of Hygiene & Tropical Medicine (GB)
- Venue
- Health Technology Assessment
- Published
- 2007-11
- Volume
- 11
- Issue
- 48
- Pages
- iii, ix-105
- ISSN
- 1366-5278 (ISSN-L)
- 2046-4924
- OpenAlex
- W2118907870
- Cited by
- 433
- References
- 100
- Citations by year
- 2026: 7 · 2025: 15 · 2024: 15 · 2023: 19 · 2022: 28 · 2021: 27 · 2020: 35 · 2019: 24 · 2018: 28 · 2017: 27 · 2016: 26 · 2015: 33 · 2014: 32 · 2013: 30 · 2012: 17
- FWCI
- 17.23
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Locations
- Health Technology Assessment (publishedVersion, cc-by)
- PubMed (publishedVersion)
- University of Brighton Repository (University of Brighton) (publishedVersion, other-oa)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- University of Brighton Repository (University of Brighton) (submittedVersion)
- Aberdeen University Research Archive (Aberdeen University) (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Newcastle University ePrints (Newcastle Univesity)
- Funders
- Health Technology Assessment programme (06/90/13)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Keywords
- trial recruitment, trial management, clinical trial participation, CRASH trial, head injury treatment, team building, recruitment barriers, research funding programs, MRC, cancer clinical trials, drug trials
- MeSH terms
- Humans, Interviews as Topic, Technology Assessment, Biomedical, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Patient Selection, Databases as Topic
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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