Planning and continuity are two of the most important elements of any clinical trial. The stakes are too high to settle for less than meticulous preparation, and turnover—among patients and within the contract researcher’s team—can hobble and even derail a trial.
The growing popularity of risk-sharing agreements between sponsors and CROs is encouraging. Focusing both parties on the elements most important to ensuring trial success early in the process and incentivizing good performance bring positive change to an industry defined by high costs and the pressure of project deadlines.
“Risk-sharing” is actually a term we avoid, preferring to view these agreements not as ways to avoid failure, but as opportunities to improve productivity and efficiency. Many people we work with take the same approach, embracing them not as trip wires for extracting penalties, but encouragement that speeds development of life changing therapies.
We typically tie a percentage of the total contract value—or alternatively, our project management fee—to milestones such as time from contract award to opening of the first study site, time from contract award to first patient screened or speed of site activation. When we recently studied a drug to treat major depressive disorder, signing up participants accounted for most of the performance incentive structure: a significant double-digit percent bonus (or penalty) tied to U.S. patient sign-ups and a bit less for each of the other two countries in the trial.
Off the table are truly lousy ideas like penalties without corresponding incentives (unthinkable) and royalties from future drug sales (too distant).
As risk-sharing evolves from a black art to a process that’s straightforward and repeatable, we’ve seen compelling results—for example, greatly improving performance in a recent Eastern European study to evaluate an adult schizophrenia drug. We accelerated the timeline for the 400-person study, and despite the industry’s high turnover rate, every member of the Premier Research team remained for its full 22-month duration.
Written by Guest Writer Sean Russell. Russell, BSc, MA, is chief commercial officer at Premier Research. Russell built and led the industry’s largest and most effective global marketing department at Quintiles Transnational. Before that, he was the founder of SR Marketing Media; he also served at Treoir Consulting and GlaxoSmithKline. He began as a lab tech at Schering Plough. He holds a BSc degree in Biochemistry from University College Cork and an MA in Marketing from University of Westminster.
This article was reprinted from Volume 23, Issue 11, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact firstname.lastname@example.org. Subscribe >>