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Details of Pfizer’s clinical trials in Nigeria in 1996 during a meningitis epidemic may still be fuzzy, but it is already clear that sponsors considering clinical trials in developing countries should follow the case closely to avoid similar problems.
When a clinical trial goes wrong, a “subject” will often begin to call themselves “patients,” and that’s where a sponsor’s real problem can begin, attorney Wayne Bond told CTA last week.
Although FDA and HHS regulations do not specifically require ethics training for international clinical studies, funding institutions such as HHS should make such training a condition when underwriting trials, suggested Melody Lin, OHRP’s deputy director.
Current policies on disclosing conflicts of interest lean more toward protecting researchers from legal liability, and less toward informing patients or proving transparency, according to a review of practices at academic medical centers.
Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, has asked the FDA for assistance in his ongoing probe into alleged abuses of clinical trial participants in for-profit testing centers.