We recently completed a study of 69 dedicated research sites, exploring issues which hinder patient recruitment and enrollment. Of those, 38 (55%) were successful — ‘successful’ is defined as sites which randomized 75% or more of patients targeted during their feasibility study. The remainder randomized less than 75% of their targeted number of patients. These were defined as ‘unsuccessful’.
Each site was asked to consider a recent study at their site. For that study, they identified the presence or absence of more than 100 factors which influence patient recruitment and enrollment. We compared the frequency of the factors among ‘successful’ vs ‘unsuccessful’ studies. For example, if 10% of ‘successful’ sites and 30% of ‘unsuccessful’ sites had an issue with CRA turnover, the difference for that factor is 20% (30% minus 10%). The following is a list of factors with the biggest differences between ‘successful’ and unsuccessful’ sites.
- Delayed payments to sites (difference = 38%)
- Payments not being received by sites (30%)
- Central laboratory results were inconsistent with local labs (29%)
- Changes in expectations from one CRA to the next (28%)
- Excessive number of screen failures (27%)
Dedicated research sites differ from academic and medical practice sites, as their business is only comprised of conducting clinical trials. Most are small businesses which depend on timely receipt of revenues from clinical trials to keep their doors open. Delayed payments to dedicated research sites forces them to stop recruiting.
In small companies, cash is king. If you are not managing ‘aging of accounts’ for your sites, start doing so now. You will be a hero to dedicated research sites, and if you ensure timely payments to sites in return you can expect to see faster and higher enrollment rates.
Ross H. Weaver, PharmD, MBA