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Published on: September 20, 2019
Using a business model approach and marketing techniques for recruitment to clinical trials
Alison M McDonald1, Shaun Treweek, Haleema Shakur
1Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen AB252ZD, UK. a.mcdonald@abdn.ac.uk
Abstract:
Randomised controlled trials (RCTs) are generally regarded as the gold standard for evaluating health care interventions. The level of uncertainty around a trial's estimate of effect is, however, frequently linked to how successful the trial has been in recruiting and retaining participants. As recruitment is often slower or more difficult than expected, with many trials failing to reach their target sample size within the timescale and funding originally envisaged, the results are often less reliable than they could have been. The high number of trials that require an extension to the recruitment period in order to reach the required sample size potentially delays the introduction of more effective therapies into routine clinical practice. Moreover, it may result in less research being undertaken as resources are redirected to extending existing trials rather than funding additional studies.Poor recruitment to publicly-funded RCTs has been much debated but there remains remarkably little clear evidence as to why many trials fail to recruit well, which recruitment methods work, in which populations and settings and for what type of intervention. One proposed solution to improving recruitment and retention is to adopt methodology from the business world to inform and structure trial management techniques.We review what is known about interventions to improve recruitment to trials. We describe a proposed business approach to trials and discuss the implementation of using a business model, using insights gained from three case studies.
Insights
Improving participant recruitment and retention in randomized controlled trials (RCTs) is crucial for reliable health intervention evidence. This review explores business management techniques to enhance trial recruitment and retention strategies.
Area of Science:
- Health research methodology
- Clinical trial management
- Evidence-based practice
Background:
- Randomized controlled trials (RCTs) are essential for evaluating healthcare interventions.
- Recruitment and retention challenges in RCTs often compromise study reliability and delay therapeutic advancements.
- There is limited evidence on effective recruitment strategies for publicly funded RCTs.
Purpose of the Study:
- To review existing interventions aimed at improving participant recruitment and retention in clinical trials.
- To propose and discuss the implementation of a business management approach for structuring trial management.
- To provide insights from case studies on applying business models to improve trial recruitment.
Main Methods:
- Literature review of interventions to improve trial recruitment and retention.
- Description of a proposed business approach tailored for clinical trial management.
- Analysis of three case studies illustrating the implementation of a business model in trials.
Main Results:
- The review synthesizes current knowledge on recruitment and retention interventions.
- A business-oriented framework for trial management is presented.
- Case studies offer practical examples of applying business principles to enhance trial recruitment and retention.
Conclusions:
- Adopting business management methodologies can offer structured approaches to overcome common recruitment and retention barriers in RCTs.
- Effective trial management, informed by business principles, can lead to more reliable research outcomes.
- Further implementation and study of business models in clinical trials are warranted to improve efficiency and success rates.
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