29 - Academic-Industry Collaborations and Compliance Issues

Summary

Clinical trials have become the center stage of recent enforcement activity and government inquiry. This chapter serves as an introduction to the compliance landscape associated with conducting clinical research in today's challenging environment. The Sunshine Act requires manufacturers of drug, device, biologics, and medical supplies covered under Medicare and Medicaid to report payments on an annual basis to the department of Health and Human Services (HHS). The Pharmaceutical Research and Manufacturers of America (PhRMA) Code sets standards for many different aspects of the health care industry, such as consultant arrangements, speaker programs, and industry support of independent medical education, business courtesies, gifts, and training of company representatives. Many different entities and individuals contribute to the safe and appropriate conduct of clinical research, including sponsoring companies, regulatory agencies, investigative site staff, medical professionals, and Institutional Review Boards and Ethics Committees.