30 August 2023

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Factors influencing patient journeys through clinical trials

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Patient-centered trial design improves recruitment and retention, increases participant satisfaction, encourages participation by a more representative cohort and allows researchers to better meet participants’ needs.

In February 2023, clinicaltrials.gov had more than 350,000 interventional trials registered across 220 countries. It is hard to estimate the premature discontinuation rates of clinical trials, as most do not report their closure to ethics committees. However, some studies estimate that up to 80% of registered clinical trials will not be completed. The most common reasons for premature trial discontinuation are inadequate recruitment and poor retention.

Research in this area mostly focusses on narrow facets of trial participation. The team aimed to systematically identify the breadth of patient-centered factors influencing participation and engagement in trials and collate them into a framework. Through this, the research team hoped to assist researchers to identify factors that could improve patient-centered trial design and delivery.

Robust qualitative and mixed methods systematic reviews are becoming increasingly common in health research.

The protocol for this review was prospectively registered on PROSPERO, CRD42020184886. The team used the SPIDER (Sample, Phenomenon of Interest, Design, Evaluation, Research Type) framework as a standardized systematic search strategy tool. Three databases were searched as well as references checking, and thematic synthesis was conducted.

Screening agreement was performed, and code and theme checking were conducted by two independent researchers. Data were drawn from 285 peer-reviewed articles. 300 discrete factors were identified and sorted into 13 themes and subthemes.

The full catalog of factors is included in the Supplementary Material. A summary framework is included in the body of the article.

This paper focuses on outlining common ground that themes share, highlighting critical features, and exploring interesting points from the data.

Through this, the authors said they hope researchers from multiple specialties may be better able to meet patients’ needs, protect patients’ psychosocial wellbeing, and optimize trial recruitment and retention, with direct positive impact on research time and cost efficiency.

Dobra R, Wilson G, Matthews J, et al. "A systematic review to identify and collate factors influencing patient journeys through clinical trials." JRSM Open. 2023;14(6). doi:10.1177/20542704231166621.