Compensation affected by the outcome of clinical studies

Under 21 CFR 54 the applicant must disclose such arrangements, because they can bias results. Equity in the sponsor and pay tied to product sales are typical examples.

Compensation affected by the outcome of clinical studies means compensation that could be higher for a favorable outcome than for an unfavorable outcome, such as compensation that is explicitly greater for a favorable result or compensation to the investigator in the form of an equity interest in the sponsor of a covered study or in the form of compensation tied to sales of the product, such as a royalty interest.

21 CFR, 54.2