Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2010 Sep 27:10:85.
doi: 10.1186/1471-2288-10-85.

IMproving PArticipation of patients in Clinical Trials--rationale and design of IMPACT

Katrien Oude Rengerink  1 , Brent C Opmeer, Sabine L M Logtenberg, Lotty Hooft, Kitty W M Bloemenkamp, Monique C Haak, Martijn A Oudijk, Marc E Spaanderman, Johannes J Duvekot, Christine Willekes, Maria G van Pampus, Martina M Porath, Jim van Eyck, Marko J Sikkema, Ben Willem J Mol
Affiliations

IMproving PArticipation of patients in Clinical Trials--rationale and design of IMPACT

Katrien Oude Rengerink et al. BMC Med Res Methodol. .

Abstract

Background: One of the most commonly reported problems of randomised trials is that recruitment is usually slower than expected. Trials will cost more and take longer, thus delaying the use of the results in clinical practice, and incomplete samples imply decreased statistical power and usefulness of its results. We aim to identify barriers and facilitators for successful patient recruitment at the level of the patient, the doctor and the hospital organization as well as the organization and design of trials over a broad range of studies.

Methods/design: We will perform two cohort studies and a case-control study in The Netherlands. The first cohort study will report on a series of multicenter trials performed in a nationwide network of clinical trials in obstetrics and gynaecology. A questionnaire will be sent to all clinicians recruiting for these trials to identify determinants--aggregated at centre level--for the recruitment rate. In a case control-study nested in this cohort we will interview patients who refused or consented participation to identify factors associated with patients' consent or refusal. In a second cohort study, we will study trials that were prospectively registered in the Netherlands Trial Register. Using a questionnaire survey we will assess whether issues on hospital organization, trial organization, planning and trial design were associated with successful recruitment, i.e. 80% of the predefined number of patients recruited within the planned time.

Discussion: This study will provide insight in barriers and facilitators for successful patient recruitment in trials. The results will be used to provide recommendations and a checklist for individual trialists to identify potential pitfalls for recruitment and judge the feasibility prior to the start of the study. Identified barriers and motivators coupled to evidence-based interventions can improve recruitment of patients in clinical trials.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Factors for lack of recruitment can be found on different levels: with interactions between levels.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Campbell MK, Snowdon C, Francis D, Elbourne D, McDonald AM, Knight R. et al.Recruitment to randomised trials: strategies for trial enrollment and participation study. The STEPS study. Health Technol Assess. 2007;11:iii. - PubMed
    1. van der Wouden JC, Blankenstein AH, Huibers MJ, van der Windt DA, Stalman WA, Verhagen AP. Survey among 78 studies showed that Lasagna's law holds in Dutch primary care research. J Clin Epidemiol. 2007;60:819–824. doi: 10.1016/j.jclinepi.2006.11.010. - DOI - PubMed
    1. Mills E, Wilson K, Rachlis B, Griffith L, Wu P, Guyatt G. et al.Barriers to participation in HIV drug trials: a systematic review. Lancet Infect Dis. 2006;6:32–38. doi: 10.1016/S1473-3099(05)70324-8. - DOI - PubMed
    1. Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol. 1999;52:1143–1156. doi: 10.1016/S0895-4356(99)00141-9. - DOI - PubMed
    1. Robinson EJ, Kerr CE, Stevens AJ, Lilford RJ, Braunholtz DA, Edwards SJ. et al.Lay public's understanding of equipoise and randomisation in randomised controlled trials. Health Technol Assess. 2005;9:1–iv. - PubMed

Publication types

LinkOut - more resources