For multiple site studies, finding the right match between sponsor and site is crucial for success. This is even more important now than it has been in the past. We have noticed that studies are using fewer sites, even if they expect to enroll the same number of subjects as before. Sponsors and CROs want the best sites for their studies, sites want the best studies for their skills, but making the right choices requires the right information.
Sponsor/CRO Seeking Experienced, Qualified Site
When looking for the right site, a sponsor should understand as much as possible about how that investigator’s team can perform. And anything that improves the selection process improves a study’s timelines. A Cutting Edge Information study found that up to 12 percent of the time spent on a trial can go to choosing and activating sites.
With that much time devoted to finding sites, the pressure is on to find ones that can perform. Sponsors and CROs try a variety of ways to assess the sites they are courting, and an article in Pharmaexec.com highlighted six areas a sponsor should consider:
- Experience in the therapeutic area
- The site’s current research workload
- How long a site typically takes to activate a study
- How long participant enrollment takes at the site
- How many enrolled participants complete the study
- The nature of the investigative site (e.g., is it a hospital-based or community site?)
These factors are not new, the challenge can be finding the best way to measure them. CenterWatch Weekly recently reported that Pfizer is building tools to do just that (April 6, 2015; subscription required), and the Pharmaexec.com article had its own suggestions. The more a sponsor or CRO can learn about a site’s experience, the better the chances for a happy union.
Site Seeking the Right Study
How can a site demonstrate that it is the right choice for a study? For a busy investigator, this question is hardly trivial. That April 6 CenterWatch Weekly article showed that typical margins at a site dropped from 20 percent to 13 percent between 2011 and 2014. And it’s hardly news to an experienced site that protocols have become more complicated. The Manhattan Institute for Policy Research found that study procedures increased by 70 percent between 1999 and 2005, and a site’s average work load increased 67 percent (Reprinted in the PAREXEL Biopharmaceutical R&D Statistical Sourcebook, 2013/2014).
Sponsors and CROs need new ways to find sites, and sites need ways to show they’re the right fit for a study. Quorum has developed a new service to help. Site Match pairs investigative sites with data points that Sponsors/CROs request. Our goal with Site Match is to help shorten the time sponsors or CROs spend looking for good matches, which helps them discover new products quickly and less expensively.