What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies

McDonald, Alison; Knight, Rosemary; Campbell, Marion K; Entwistle, Vikki; Grant, Adrian; Cook, Jonathan; Elbourne, Diana; Francis, David; Garcia, Jo; Roberts, Ian; Snowdon, Claire

doi:10.1186/1745-6215-7-9

Cited by 767 publications

(739 citation statements)

References 6 publications

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“…Investigators must always take into account over estimation of potential participants from collaborating sites when deciding on the number of centers and sample size per site [19]. In a review of randomized controlled trials, only 31% of trials achieved their original recruitment target and 50% required an extension to achieve adequate sample size [20]. There may be several reasons for these delays.…”

Section: Recruitmentmentioning

confidence: 99%

Implementation of genomics research in Africa: challenges and recommendations

Adebamowo

Francis

Tambo

et al. 2018

Global Health Action

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Background: There is exponential growth in the interest and implementation of genomics research in Africa. This growth has been facilitated by the Human Hereditary and Health in Africa (H3Africa) initiative, which aims to promote a contemporary research approach to the study of genomics and environmental determinants of common diseases in African populations. Objective: The purpose of this article is to describe important challenges affecting genomics research implementation in Africa. Methods: The observations, challenges and recommendations presented in this article were obtained through discussions by African scientists at teleconferences and face-to-face meetings, seminars at consortium conferences and in-depth individual discussions. Results: Challenges affecting genomics research implementation in Africa, which are related to limited resources include ill-equipped facilities, poor accessibility to research centers, lack of expertise and an enabling environment for research activities in local hospitals. Challenges related to the research study include delayed funding, extensive procedures and interventions requiring multiple visits, delays setting up research teams and insufficient staff training, language barriers and an underappreciation of cultural norms. While many African countries are struggling to initiate genomics projects, others have set up genomics research facilities that meet international standards. Conclusions: The lessons learned in implementing successful genomics projects in Africa are recommended as strategies to overcome these challenges. These recommendations may guide the development and application of new research programs in low-resource settings.

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Section: Recruitmentmentioning

confidence: 99%

Implementation of genomics research in Africa: challenges and recommendations

Adebamowo

Francis

Tambo

et al. 2018

Global Health Action

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“…Studies such as the Prostate Cancer Intervention Versus Observation Trial [5] and the Prostate Testing for Cancer and Treatment trial (ProtecT) study [6,7] demonstrate that urological RCTs can be undertaken successfully. However, less than a third of trials achieve their original recruitment target [8].…”

Section: Introductionmentioning

confidence: 99%

Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

et al. 2017

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Context: The importance of evidence from randomised trials is now widely recognised, although recruitment is often difficult. Qualitative research has shown promise in identifying the key barriers to recruitment, and interventions have been developed to reduce organisational difficulties and support clinicians undertaking recruitment. Objective: This article provides an introduction to qualitative research techniques and explains how this approach can be used to understand-and subsequently improverecruitment and informed consent within a range of clinical trials. Evidence acquisition: A literature search was performed using Medline, Embase, and CINAHL. All studies with qualitative research methods that focused on the recruitment activity of clinicians were included in the review. Evidence synthesis: The majority of studies reported that organisational difficulties and lack of time for clinical staff were key barriers to recruitment. However, a synthesis of qualitative studies highlighted the intellectual and emotional challenges that arise when combining research with clinical roles, particularly in relation to equipoise and patient eligibility. To support recruiters to become more comfortable with the design and principles of randomised controlled trials, interventions have been developed, including the QuinteT Recruitment Intervention, which comprises in-depth investigation of recruitment obstacles in real time, followed by implementation of tailored strategies to address these challenges as the trial proceeds. Conclusions: Qualitative research can provide important insights into the complexities of recruitment to trials and inform the development of interventions, and provide support and training initiatives as required. Investigators should consider implementing such methods in trials expected to be challenging or recruiting below target. Patient summary: Qualitative research is a term used to describe a range of methods that can be implemented to understand participants' perspectives and behaviours. Data are gathered from interviews, focus groups, or observations. In this review, we demonstrate how this approach can be used to understand-and improve-recruitment to clinical trials. Taken together, our review suggests that healthcare professionals can find recruiting to trials challenging and require support with this process.

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“…Methodological research suggests that this vital preparatory work is often skimped. 38 Evaluations are often undermined by problems of acceptability, 39 40 compliance, 41 delivery of the intervention, recruitment and retention, [42][43][44] smaller-than-expected effect sizes, and so on, that could be anticipated by thorough piloting. A pilot study need not be a 'scale model' of the planned mainstage evaluation, but should address the main uncertainties that have been identified in the development work (Case study 3).…”

Section: Figure 1 Key Elements Of the Development And Evaluation Processmentioning

confidence: 99%