The FDA financial disclosure regulations are designed to help uncover potential investigator bias that may arise due to financial ties between the investigator and the clinical trial sponsor.
On 24 May 2011 the U.S. Food and Drug Administration (FDA) released draft guidance to replace its current guidance on disclosure of financial interests held by clinical investigators. The draft guidance reflects the changing landscape both within and outside the FDA regarding transparency of financial interests. Consistent with increased public attention to physician industry financial ties, the tenor of the draft guidance suggests that clinical trial sponsors should expect a more rigorous review by the FDA of these financial arrangements. Comments on the draft guidance must be submitted by 25 July 2011.
For an in depth discussion of the current FDA guidance and regulations, please view Part I and Part II of the financial disclosure series recently published by RAPS.