BIO Seeks Clinical Trial Reforms To Protect Patients And Encourage Research

Washington, D.C. (May 22, 2001) – Bernice Welles, M.D., will speak on behalf of the Biotechnology Industry Organization Wednesday at a Senate hearing to discuss possible reforms of the system of protection for human subjects who volunteer for research projects and clinical trials. Dr. Welles is senior director of medical affairs for Genentech Inc. (South San Francisco, Calif.)

“BIO companies believe that it is critical to make sure that, despite the changes in our research infrastructure over the years, participants continue to be protected,” said Dr. Welles. “In protecting research participants, we must also ensure the continuation of valuable – often life-saving – research. Decades of responsible science have shown that protecting research participants and promoting medical research are mutually attainable.”

BIO member companies have spent the past several months evaluating the existing system of research oversight and developing key principles we hope legislators and regulators will consider, including:

(1) eliminate multiple separate levels of review;
(2) modify the regulatory framework so that review is commensurate with the type of risk involved for the research participants;
(3) preempt state laws that create conflicting obligations; and
(4) work with academic medical centers and other affected entities and individuals to develop an approach for addressing real and perceived conflicts of interest.

The hearing is being conducted by the Senate Health, Education, Labor and Pensions Subcommittee on Public Health. It will be held at 9:30 a.m., Wednesday, May 23, in room 430 of the Dirksen Senate Office Building. Copies of Dr. Welles’ testimony will be available for members of the press.

BIO represents more than 950 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations. BIO members are involved in the research and development of health care, agricultural, industrial and environmental biotechnology products.