Exploring the FDA’s guidance on financial disclosure by clinical investigators

[Adam Fleming]

Transparency and integrity of the financial interests of clinical investigators is a matter of utmost importance to the healthcare industry in the US. The financial interests of the investigators are directly associated with the results, thinks the FDA. It believes that “financial interests and arrangements of clinical investigators…could affect reliability of data submitted to FDA”.

Keeping this highly important aspect, which could have a serious bearing on the integrity of the clinical trials and eventually, on the healthcare sector itself, in mind; the FDA released its draft guidance in the spring of 2011. This guidance, which replaced the earlier one of 1998, included the changes that had taken in the intervening years in the area of clinical trials and the FDA’s thinking. The draft guidance of 2011 took into consideration the public feeling about the physician-industry financial nexus and how these interests could affect the outcome of clinical trials.

The 21 CFR 54:

The core aim of the draft guidance is to discover the financial linkage between the healthcare organization that carries out the clinical trial and the physician who is the source from whom the drugs get prescribed after they are successfully tested and approved. Towards this end, the FDA has set guidelines that require the stakeholders in a clinical trial to make declarations to the FDA about their financial interests. These are part of 21 CFR 54.

The way in which this draft is to be implemented will be the core of a valuable learning session from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. Professionals can enroll for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=500833L...

David Dills, a highly experienced Global Regulatory Affairs & Compliance Consultant will be the speaker at this webinar. He will address the most pressing changes and discuss the issues that the FDA has received from industry and the public.

David will cover the following areas at this webinar:

o  Review proposed changes to the 2011 released draft guidance

o  Clarification on definition of sponsor

o  Understand FDA’s clear actions that can and will be taken regarding refuse to file a marketing application

o  Learn how to submit financial disclosure information to FDA

o  Why FDA is expounding on due diligence and its significance

o  Timing of data collection and purpose

o  Understand how financial information should be disclosed to FDA

o  Update regarding financial disclosure questionnaires

o  Time period covered by regulations

o  Clarification on covered clinical study

o  Factors for FDA review of disclosed financial interests