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Transparency in Investigator Initiated Trials
Professional relationships with physicians are extremely important sources of collaboration for medical products companies. Physicians provide technical input, identify unmet needs, and perhaps most critically, conduct clinical trial administration and oversight. But these very areas have been underlined by OIG and DOJ investigators as targets of special scrutiny going forward. The FDA is also tightening require-ments for product approval, making the need for high quality clinical collaboration that much more critical. The growing corporate challenge, then, will be to mitigate compliance risk, and at the same time ensure that increased enforcement scrutiny, disclosure requirements, and procedural safeguards don’t alienate these valuable resources.
The answer to this challenge is to reassess the process of selecting professional partners to ensure that value, rather than other considerations, are clearly and transparently at the center of those exchanges. Taking this approach not only minimizes compliance liability; it also improves outcomes by focusing on the match between task requirements and partner capabilities. Using clinical trial administration as an example, recognizing the factors that truly make for an effective physician collaborator has the potential to bring such activities to a whole new level of cost- and outcome effectiveness.Read More
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