In our experience early enrollment may be more critical in determining the success of a trial than any other factor. Failing to meet enrollment deadlines is listed as the number one reason why subsequent trials, regulatory filings and market applications are delayed. Operating as a full service clinical research organization (CRO), JANIX squarely views patient recruitment and retention as a core aspect of running a clinical trial. In undertaking a vigorous assessment of the natural history of patient enrollment in over 200 randomized efficacy trials, we have examined the predictors determining the ability of a study to reach or not reach a 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 demonstrate 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 (epidemiology, orphan drug status), eligibility criteria, phase and attractiveness of a trial, treatment naivety requirements, timeframe of the study, and adequacy of the network of clinical sites represent only a few of the key factors influencing patient participation in a clinical study. Compounding these common factors is a hyper-competitive clinical landscape of therapeutics in development across multiple disease indications, making access to patients even more limited. Overall, early enrollment is indicative of the future pace of recruitment and offers strong evidence as to the feasibility of a trial.

Given the significant importance of patient recruitment and its impact on the length and therefore cost of a trial, JANIX has developed a wide spectrum of strategies designed to help steer sites 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 niche field of expertise. Typical CROs do not appreciate the significant challenge of patient enrollment, dedicate few resources, or initiate activities on a reactive rather than proactive basis late in the course of a trial which reduces the potential for any substantive impact.

In domestic and international settings, JANIX has implemented the infrastructure, study materials, and championed outreach initiatives for sponsors to meet trial participation requirements within accelerated timeframes. Further information on this important topic in clinical research is presented in the JANIX newsletter obtained through the link provided, which examines the general principles, lists a diverse array of specific initiatives, presents lessons learned, international concerns, case studies, and overall concepts we have employed confidently to meet demanding enrollment goals.

For more information click here or contact us at Bus.dev@janix.com

Sincerely,

JANIX, Inc.