Federally funded clinical trials may soon become less bureaucratically bound and more efficient if changes announced by the Department of Health and Human Services (HHS) come to pass. These federal rules regulating clinical trials were instated in 1981, but they have not kept pace with evolving practices and needs. While the majority of U.S. clinical trials once took place in academia, as a result of burdensome regulatory costs, now 70 percent of them are commercial and nearly half take place outside the U.S.
HHS proposes to speed the approving and monitoring process of clinical trials by streamlining how they are reviewed. Currently, each site participating in a multi-site trial must have an internal review board (IRB) that ensures compliance with federal regulations and sees that trial participants are informed of risks and protected from dangerous protocols. The new proposal would require that just a single IRB be responsible for all sites in such trials, making them less costly and less headache-inducing for the physicians who oversee them. Furthermore, review boards for minimal risk studies, such as those that involve surveys or focus on education or the social sciences, would be eliminated. The HHS also proposes to clarify the paperwork involved in such trials, limiting the length of informed-consent documents and eliminating complex legal jargon.
These are long overdue improvements, ACSH's Dr. Gilbert Ross remarks, noting the positive reaction of the research community to the proposal. Let s hope it helps stem the flow of clinical trials to overseas regions where lesser regulation has drawn them. ACSH s Dr. Ruth Kava also thinks the proposal is good news. She pointed to the limit on the length of informed-consent documents as being especially important for patients, too: The format affects what they understand and agree to, she says.
The deadline for public comment on the proposal is September 26. After comments have been reviewed, HHS will issue a proposed rule.
