Patient Recruitment And Retention Strategy In Clinical Trials: Data-Driven And Evidence-Based Approach

By Narender Dureja and Nidhi Bajpai, HCL Technologies

In a clinical trial considering different phases, there is a need for subjects to be enrolled as per the eligibility criteria defined in the study protocol. Aiming and holding the involvement of the suitable patients places a critical challenge for investigators and sponsors of the trial. During the conduct-phase of clinical trials, sites usually spend most of their time on patient recruitment, and yet, statistics show that despite their efforts, reaching enrollment goals per timelines seem elusive in many studies. The majority (nearly 86%) of clinical trials conducted in the United States fail to enroll subjects within the contract period. It is commonly observed that once the desired subject count is achieved for a study, activities required to enhance patient retention gets ignored. This may result in nearly one-quarter of study volunteers drop out before completing the study.

The industry perspective reflects that it is the unabridged responsibility of the investigator to recruit and retain patients in clinical trials. Thus sponsors totally depend on healthcare professionals, who in turn, leave it to patient’s foot fall to the site to achieve study enrollment objectives. Typically the methodology adopted is generic in nature3 i.e. the same technique for subject recruitment is embraced for trials of different therapeutic areas. Also, the same groups of patients are referred from the site’s internal database for different trials. Literature suggests that the bulk of prescreened eligible subjects are lost before they are enrolled.

Too small a subject pool or localized sites in a particular geography can incorporate an element of bias in the study. The challenge is underlined by heavy competition among players in the same therapeutic area. Poor enrollment and retention warrants for extra cost, as replacement patients and rescue sites may mean more overheads, wastage of study resources, increased timelines, lesser accuracy, protocol deviations and decreased return on investment (ROI).