The research site: Contract negotiation underdog
When a site is chosen for a clinical trial, it can be gratifying and frustrating at the same time.
Your first thought is, “Yes! We have been selected for an amazing new trial.” The many hours of study startup work have finally come to fruition. But now the real hustle gets underway: regulatory-package processing, access to multiple training portals, trip planning for the investigator meeting, equipment starting to roll in—the list goes on and on.
Then come the contract and budget, and the real fun begins. Let’s see what they are offering us for our promise to fulfill all study deadlines and also to do so expeditiously and thoughtfully: “Study startup: $1,500.”
Hmm. We have already spent more than that amount on our efforts leading up to this point.
“Recruitment funds: Not available using central advertising vendor.”
Bummer. We have already prepared a list of 3,000 prequalified potential subjects from our database and we want to reach out to these patients via mail. How are we going to pay for that?
The bottom line here: We are the little guy in this negotiation. We have 10 employees. The sponsor has 13,000.
We do not have the staff to spend countless hours negotiating. We really do know that the study will be a success at our site and we can collect good, clean data. We also know that our patients may truly benefit from the trial.
We have worked hard to become a responsible and accountable site. The final piece to make our site a success would be profitable. We truly enjoy what we do at our site and understand we are a crucial piece to the clinical research machine.
We can only hope that as the industry changes and grows, the underdog may finally get what it deserves.
Written by Guest Writer Sarah Yuhasz. Yuhasz is director of research at Clinsite in Ann Arbor, Mich.
This article was reprinted from Volume 22, Issue 12, 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 >>