Proposed FDA Guidance on Financial Disclosure and the Physician Payment Sunshine Regulations – Divergent Paths and Duplicated Efforts

Conclusion  The increased regulation and requirements to disclose FCOIs creates a tremendous burden for researchers and institutions that are repetitive, overlapping but not-identical, and time-consuming.  Nevertheless, institutions that receive PHS funding can manage FCOIs in a number of ways: (1) public disclosure of the FCOI (e.g., when presenting or publishing the research); (2) disclosure of the FCOI directly to human participants; (3) appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI; (4) modification of the research plan; (5) change of personnel or responsibilities, or disqualification of personnel from participation in all or a portion of the research; (6) reduction or elimination of the financial interest (e.g., sale of an equity interest); or (7) severance of relationships that create FCOI.    Institutions that sponsor or oversee clinical trials for marketing applications for an FDA product must also take steps to minimize bias.  FDA will consider elements of the study design, including the method of randomization, the level of blinding (e.g., double-blind), the presence or absence of a control group, whether placebo or active, the nature of the primary and secondary endpoints (objective, subjective), the method of endpoint assessment, the method of evaluation (including whether someone other than the disclosing investigator measured the endpoint...
Source: Policy and Medicine - Category: Health Medicine and Bioethics Commentators Authors: Source Type: blogs