Industry, academic researchers, and clinical trials: the slippery slope

Ed Silverman’s venerable Pharmalot blog recently posted a useful summary of some of the conflict of interest problems that come up when physicians enroll their patients in clinical trials. The basis for the article was a 62-page paper from the  Center for Health & Pharmaceutical Law & Policy at the Seton Hall Law School.

But what really caught our eye was a detailed comment at the bottom of the post by “Pharmavet,” who is, apparently, a pharmaceutical executive with extensive experience in the clinical trials arena. You should read his entire comment, filled with insights gained from years of daily battle in the trenches, but here are a few highlights:

  • During pre-study visits principal investigators (PIs) will routinely under-report the number of studies they are currently doing, because “they know that they can get away with a low number because we have no legal means of verification.” Then when enrollment is sluggish after the study starts, “you find out from the coordinator that the PI is really doing a ton of studies in your disease states, you resort to ‘incentivizing’ the PI per the white paper to give your study priority, thus starts the slippery slope.”
  • PIs can make a lot of money just by screening lots of patients who are not eligible for the trial. Pharmavet’s counter-strategy: “I used to cap them [screen failures] at 15% of the total budget.”
  • And here’s my favorite point from Pharmavet, providing strong evidence that in some circumstances at least industry executives may have higher ethical standards than academic researchers: “One simple rule. If I use a physician as a PI I don’t use him as a speaker, and vice verse. This reduces conflict of interest.”

Speak Your Mind