FDAnews Drug Daily Bulletin

International Trials Seen as Challenge for Patient Protection

Aug. 23, 2007

Almost one-quarter of patients in NIH-funded clinical trials are not in the U.S., and the numbers are rising, Bernard Schwetz, outgoing HHS Office for Human Research Protections (OHRP) director, said.

In an exclusive interview on the eve of his retirement, Schwetz listed the increase in international trials as one of the major human research protection challenges his successor will face. “There’s no reason to believe that won’t continue, and we have less knowledge and less confidence [in our] knowledge about those [foreign-based trials] than about the domestic scene. That makes me nervous.”

The next OHRP director should also keep trying to focus on clinical investigators, Schwetz said. When he assumed the directorship, he said, “I found a mismatch between where OHRP was focusing its attention and where the greatest risk to subjects was. OHRP was traditionally and naturally connected to the IRB [institutional review board] community, but the greatest risk to subjects is at the hands of investigators.”

Unfortunately, OHRP “had little contact with investigators,” and Schwetz said his efforts to establish direct contact by inviting them to conferences “hit a blank wall,” since they are busy writing grant proposals, seeing patients and otherwise engaging in research. “I began to search for a means to contact investigators more efficiently than my requests to meet with them directly.”

Therefore, Schwetz said, he began a concerted outreach effort targeting “institutional signatory officials” who are responsible for training investigators and protecting patients under their care.