Critical Independence
The FDA guidance for establishment and operation of data monitoring committees states; “An independent DMC, is a committee whose members are considered to be independent of those sponsoring, organizing, and conducting the trial.” FDA Guidance 2006. INDEPENDENCE is an FDA requirement for the board. All parties involved must be free from bias to evaluate the data for safety and efficacy.
Sponsor Independence
The sponsor is the author of the protocol, has a vested interest in the new product, and is not independent. The sponsor should be very hands off of all DSMB activity; their role is to give an update at the open portion of the meetings.
Study Organizer Independence
In addition to the sponsor company, any organizer of the trial (CRO) should be completely independent of the DSMB. CRO have a financial interest in the clinical trial going forward, they are collecting the data, and in many cases are also doing the data management.
Corporate Transparency
The goal of the DSMB correlates to the objectives of Sarbanes-Oxley; to promote ethical business practices, enhance transparency and completeness, hold companies responsible, and to achieve new levels of corporate excellence.
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