FDA, klinik araştırmacılara yönelik Finansal Bildirim Rehberini finalize etti (İng)

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FDA Finalizes Guidance to Address Financial Disclosure by Clinical Investigators 

FDA has finalized its guidance on financial disclosure for clinical investigators. A draft of the guidance, published in May 2011, was developed in response to a 2009 report from the Office of the Inspector General (OIG) that criticized the practices of investigators, clinical trial sponsors, and the Agency on this issue. The final guidance responds to comments received on the 2011 draft and differs in several key respects, including that it: 

  • Describes a more flexible approach to “due diligence” by suggesting that sponsors and/or applicants use “reasonable judgment” in deciding how much effort should be expended to collect financial information and suggesting that they make “more than one attempt” at contacting an investigator using “more than one method of communication.”
  • Provides an expanded description of FDA’s review of clinical investigator financial disclosure information.
  • Sets forth FDA’s intention to provide information about the number of clinical investigators with disclosable financial interests or arrangements in the new product reviews posted online for an approval decision. This information will not identify clinical investigators by name.
  • Clarifies that the $25,000 threshold amount for reporting “significant payments of other sorts” (SPOOS) is based on the cumulative amount of SPOOS received by the clinical investigator over the course of the study and for one year following completion of the study and not on the amount received annually.
  • Provides additional clarification of key terms, including ‘‘clinical investigator,” “covered clinical study,” “applicant,’’ “material support,” “dependent child,” “sponsor of the covered clinical study,” and “other responsible corporate official or representative.”
  • Like the draft, the guidance is intended to help clinical investigators, industry, and FDA staff interpret and comply with the regulations governing financial disclosure by clinical investigators at 21 C.F.R. Part 54. Under this part, applicants that submit a marketing application for a drug, biological product, or device are required to submit specific information regarding the compensation to and financial interests and arrangements of any clinical investigator conducting certain clinical studies covered by the regulation, or to certify that such information is unavailable. This disclosure requirement extends to compensation and financial interests existing during the course of the study and for one year after completion of the study. 

The guidance employs a question and answer format to address practical issues associated with disclosure. It includes recommendations for determining the disclosure period and dealing with sponsor or investigator changes during the study.