Good Clinical Practice: A Question & Answer Reference Guide - May 2012 - (Page 457)

Section 13: Conflicts of Interest/Financial Disclosure 13.1 Q. In response to press reports of physicians receiving significant grants and payments from pharmaceutical and medical device firms, members of Congress promised legislation that would require such payments to be publicly disclosed, a promised that was fulfilled with the passage of the Patient Protection and Affordable Care Act of 2010. What are the implications of this legislation? A. After being introduced in January 2009 by Sen. Chuck Grassley (R-Iowa), the Physician Payments Sunshine Act, which calls for drug, device, and biologics companies to report to the U.S. Department of Health and Human Services (HHS) any payments (any amounts over $10, or amounts totaling $100 or more within a year) that they make to physicians, including clinical researchers, was ultimately rolled into the healthcare reform bill in October 2009 and was enacted as part of the reform bill in March 2010. Although the bill requires annual reporting by companies, public disclosure of clinical research-related payments will be delayed (e.g., until the date of the product’s approval or four years after payment was made, whichever comes first). Investigator payments for post-marketing clinical studies, however, will be disclosed annually. By March 2013, the law requires that companies submit: an annual report to HHS disclosing any payments (cash, stock, items, or services) made to a “covered recipient” after December 13, 2011; the recipient’s name, address, medical specialty, amount received, and the date of payment; and whether the payment is related to a specific drug or medical product. Companies must disclose payments for travel, food, educational expenses, consulting fees, and compensation for speaking engagements at continuing medical education programs. The law’s passage comes after years of growing concerns regarding financial influences and conflict of interest in clinical research and medicine. In an April 2009 report, the Institute of Medicine’s Committee on Conflict of Interest in Medical Research, Education, and Practice recommended that Congress create a national reporting program requiring companies to make public all payments to physicians, researchers, health care institutions, professional societies, patient advocacy and disease groups, and continuing medical education providers. 13.2 Q. Under the FDA’s financial disclosure regulations (Part 54), an NDA applicant is required to submit to the agency a list of clinical investigators who conducted “covered clinical studies” and to either: (1) certify that no financial arrangements with an investigator have been made where study outcome could affect compensation, that the investigator does not have a significant equity interest in the sponsor of the covered study, and that the investigator has not received significant payments of other sorts; or (2) disclose specified financial arrangements and any steps taken to minimize the potential for bias. For what individuals must the applicant submit financial disclosure/certification information—for example, must the applicant collect and submit such information for subinvestigators, study coordinators, and other key study staff? A. The FDA’s financial disclosure regulations (Part 54) require such reporting for “only a listed or identified investigator or subinvestigator who is directly involved in the treatment or evaluation of research subjects. The term also includes the spouse and each dependent child of the investigator.” Perhaps complicating this area—and possibly creating new FDA expectations in the financial disclosure certification area—is what some view as recent evolution in terms of which individuals the agency believes should be listed as subinvestigators. In its May 2010 guidance document entitled, “Frequently Asked Questions—Statement of Investigator (Form FDA 1572), the agency notes that, “under 21 CFR Part 54 (Disclosure of Financial Interests by Clinical Investigators), a person listed or identified as an investigator or subinvestigator who is directly involved in the treatment or evaluation of research subjects must submit financial disclosure information to the sponsor. For purposes of this financial disclosure regulation, the term investigator also includes the spouse and each dependent child of the investigator and subinvestigator.” In November 2007 correspondence on this question, the FDA stated that, “hospital staff, including nurses, residents, or fellows and office staff who provide ancillary or intermittent care but who do not make a direct and significant contribution to the data do not need to be listed individually [on the 1572 as subinvestigators] . . . [But 457

Table of Contents for the Digital Edition of Good Clinical Practice: A Question & Answer Reference Guide - May 2012

Good Clinical Practice: A Question & Answer Reference Guide - May 2012
Table of Contents
Introduction
Section 1: GCP Regulations, Standards and Guidelines for Clinical Research
Section 2: Investigators/Sites
Section 3: Form FDA-1572/Statement of the Investigator
Section 4: Study Sponsors and Clinical Trial Monitoring
Section 5: Informed Consent
Section 6: Source Data/Documentation
Section 7: Clinical Trial Protocols/Protocol Changes/Protocol Violations
Section 8: Institutional Review Boards
Section 9: Drug/Study Safety and Safety Reporting
Section 10: FDA Inspections, Quality Assurance Activities, and Study Auditing
Section 11: Computerized Systems, e-Clinical Trials, and Electronic Records Rules
Section 12: Patient Recruitment
Section 13: Conflicts of Interest/Financial Disclosure
Section 14: The HIPAA Privacy Rule and FDA-Regulated Clinical Trials
Section 15: Drug Accountability, Administration, and Labeling
Section 16: Fraud, Negligence, and Regulatory Non-Compliance
Section 17: Subject Diaries
Section 18: GCP and Clinical Research Standards in the European Union and An Interview with Fergus Sweeney, Ph.D., EMA Head of Sector, Compliance and Inspection
Section 19: Clinical Trial and GCP Standards in Selected Leading Countries/Regions: Latin America, China, Russia, Ukraine, and India
Section 20: GCP Compliance Statistics and Trends
21 CFR Part 11 — Electronic Records; Electronic Signatures
21 CFR Part 50 — Protection of Human Subjects
21 CFR Part 54 — Financial Disclosure by Clinical Investigators
21 CFR Part 56 — Institutional Review Boards
21 CFR Part 312 — Investigational New Drug Application
ICH Consolidated Guideline on Good Clinical Practice (E6)
ICH Guideline on Clinical Safety Data Management (E2A)
European Union Clinical Trials Directive
European Union Good Clinical Practice Directive

Good Clinical Practice: A Question & Answer Reference Guide - May 2012