To improve patient protection in clinical trials, an Institute of Medicine panel is recommending a voluntary accreditation system to certify when research organizations meet standards.
High-profile failures highlight the flaws of the current piecemeal system, said panelist Mary Faith Marshall, PhD, professor of medicine and bioethics at Kansas University Medical Center. "People realize that the system is broken, at least in part."
The current system was designed when government-funded, single-institution studies were the norm. Today, typical phase-3 trials involve dozens of institutions and thousands of patients and may be funded by drug companies. Institutional review boards are overwhelmed, said Marshall.
The report says accreditation is one tool for improvement, giving research organizations an incentive to meet quality standards. "It's a voluntary way of assuring research participants that they are going to have protections above and beyond the regulations, regardless of who's funding the research," said Marshall.
The panel . . . [Full Text of this Article]
