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Preparing for Increased Regulatory Scrutiny of Investigator Compensation (WP230)

Investigator Initiated Trials Compensation

In interviews with company executives, CEI analysts found a wide range of preparation, concern and commitment to applying OIG regulations to investigator compensation. Most companies showed marginal concerned for establishing clear and defined processes. Without the heat of scrutiny, these companies believe their current compensation processes—and an awareness of regulation on the commercial side—provide enough protection. This approach may stand while regulatory oversight rests squarely upon commercial relationships, but scrutiny has already begun to bleed over into clinical operations.

Regulatory bodies already monitor publications, and several publishers are instituting stricter rules about what they will and will not publish. For example, thought leaders who give speeches and lead clinical trials for the same company display an obvious connection for regulators. Doctors conducting small clinical trials at their practices could come under scrutiny for their prescribing behaviors. One interviewed executive at a top 20 pharmaceutical company stated that, due to the prosecutorial and regulatory issues, the compliance department at his company exhibits increasing concern about the method the company uses to arrive for investigator initiated trials compensation.

Commercial FMV processes and payments require straightforward steps and the enactment of clearly defined policies. CEI analysts found that this straightforward approach does not cohere with clinical operations, due to the breadth of its responsibilities and the complexity of its organization. Yet, although many companies had to start from scratch — both culturally and procedurally — in implementing FMV processes to remain compliant, standard clinical practices have laid a foundation for compensation compliance. This foundation leaves companies in a more flexible but complicated position. While there is not one standard method to put FMV checks in place, companies can integrate them into existing structures.


You may also be interested in CEIConnect: The Lifesciences Industry’s On-Demand Research Resource as well as our individual clinical development research reports. Cutting Edge Information also offers FMVConnect: The Premier Global HCP Fair Market Value Benchmarking Solution as well as FMV benchmarking reports.