FDA Developing Rules For Clinical Trial Oversight
The FDA and the HHS Office for Human Research Protections are working on a final rule for registering institutional review boards, marking the first FDA effort to issue regulations instead of guidances for clinical trials, FDANews reports.
Existing FDA regs don’t take into account all the different types of organizations - vendors, co-investigators, site management organizations and contract research organizations - involved in conducting clinical trials, David Lepay, the agency’s senior advisor for clinical science, told the Association of Clinical Research Professionals annual conference, FDANews writes.
What are some of the problems? Let’s start with the fact that FDA regs fail to account for electronic data issues, data standardization, electronic health records, electronic patient-reported outcomes and electronic case report forms. “We are working with groups within and outside the FDA to address this,” Lepay said.
The FDA also is working to improve its internal processes to address “why it takes so long to disqualify clinical investigators” caught in wrongdoing, Lepay added. In March, two Republican congressmen asked the Government Accountability Office to examine why the agency has been so slow to discipline investigators (back story).
Lilli
Congress is to blame for allowing the oversight===everyone is greedy and not interested in the health of the people. It is a cruel ruthless sad world. We must make our elected and appointed officals be responsible and accountable——if not be disciplined and punished. What is Mike Leavitt doing? Working for his own interests!