Cross-Pharma Precompetitive Databank Project

By Rob Wright

Elise Felicion is the director of clinical trial innovation for J&J’s Janssen. Along with her co-presenters, Laura Galuchie, global trial management lead for Merck, and Mike Luker, clinical research director for Eli Lilly, Felicion walked the audience through the typical approach to getting a physician to function as an investigator for a clinical trial. Step 1 — recruit the physician to participate. Step 2 — train the physician on good clinical practice (GCP). Step 3 — have the physician repeat step 2 for each company with which they are willing to serve as a clinical trial investigator. This is the problem which results from the unwillingness to share precompetitive information and probably why >50% of clinical trial investigators conduct only one or two trials and then stop doing so.

The sharing of GCP training information seems to be an obvious and simple solution to the problem. However, the implementation of such a scheme involves a lot of moving parts. For example, the team had to figure out ways to gain consent of every one of their GCP trained providers in order to be able to share the information. The team had to overcome internal resistance to communicating with other companies. The team had to gain buy in from legal departments on the benefits of sharing this precompetitive information, which would eventually result in significant cost savings, and hopefully, increased retention of clinical trial investigators. Privacy documents had to be drafted. A central data warehouse had to be agreed upon, independent of the three companies. Through perseverance, all of these issues were overcome, including the selection of drugdev.org as the organization in which to store investigator data. Their message: don’t allow a few speed bumps prevent you from achieving the objective when implementing a disruptive innovation. Take the first step, and expect resistance to change. This is a normal human response. What is not normal is continuing to do things as they have always been done and expecting a different outcome.