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Principal Investigators- “One and Done”

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Jim Kremidas is the executive director of Association of Clinical Research Professionals (ACRP) and recently wrote an editorial for Clinical Leader. Mr. Kremidas raises the considerable problems with the “one and done” phenomena with clinical research investigators, in which a physician will sign up to become a clinical research investigator and undertake just one trial and thereafter call it quits. This can be due to any number of factors from the costs and hassles of compliance, to payment terms of big pharma.

Kremidas points to considerable evidence including a 2014 Tufts Center for the Study of Drug Development study where investigator turnover continued to worsen even among active investigators. The reasons behind the churn are many and actually well known in the industry. Solving the problem represents a whole other matter. TrialSite News is working with The Alliance for Clinical Research Excellence and Safety (ACRES) on a new accreditation standard that we believe will make a huge difference over time in the area of principal investigator participation.

ACRP’s Mr. Kremidas is an industry veteran who will surely have strong opions with experience to back them. He spent decades working in the industry both on the sponsor side (Eli Lilly) as well as VP in a couple large CROs. I interacted with Kremidas back when I was involved with patient recruitment efforts with MMG, and strongly recommend his knowledge, expertise and wisdom in contributing how to move the industry away from “one and done.”

 

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