Factors Impacting Patient Enrollment

In our experience early enrollment may be more decisive for the fate of a trial than any other factor. Failing to meet enrollment deadlines is listed as the number one reason why clinical trials and regulatory filings are delayed. Operating as a full spectrum clinical research organization (CRO), JANIX squarely views patient recruitment and retention as a core service and essential aspect of running a successful trial. In undertaking an assessment of the natural history of patient enrollment in a number of randomized efficacy trials, we have examined the predictors determining the ability of trials to reach or not reach their target sample size. In our continuing analysis, many companies and/or CROs do not consistently employ patient recruitment strategies and therefore, lack an appreciation for the fact that early enrollment trajectories will show that the initial rate of accrual largely determines subsequent rates of enrollment, particularly during the first month or two strongly correlating with future rates of accrual.

The patient pool, eligibility criteria, attractiveness of a trial and adequacy of the network of clinical sites are some key factors that influence clinical trial enrollment. Compounding these factors is the hyper-competitive clinical landscape of therapeutics in development, making access to patients even more difficult. Overall, early enrollment is indicative of the future pace of recruitment and offers strong evidence as to the feasibility of a trial.

Given the critical importance of patient recruitment and its impact on the length and therefore cost of a trial, JANIX has developed a full spectrum of services designed to steer a trial towards meeting sponsor enrollment goals. We believe patient recruitment and retention services are a cardinal aspect of any successful CRO service provider rather than an ancillary or sub-contracted service. Typical CROs either do not appreciate the significant challenge of patient enrollment issues or implement strategies on a reactive rather than proactive basis.

In domestic and international settings, JANIX has implemented the infrastructure, study materials, and outreach initiatives for sponsors to meet trial participation requirements within accelerated timeframes. This newsletter examines in detail and aims to extensively cover general principles, list a diverse array of specific initiatives, present lesson learned, and cover international considerations, case studies, and overall concepts we have employed with confidence to meet demanding enrollment goals.

By Janice Sidorick, JANIX CEO

© 2017 JANIX BioSciences, LLC           Employment         Physician / Site Recruitment