The FDA has proposed rules requiring clinical investigators to disclosefinancial interests that might bias their findings on drugs and medicaldevices they are testing.The rules, according to the FDA, are not designed to prohibit financialarrangements between companies and scientists conducting clinicalstudies. The agency said the rules are aimed at creating a mechanism tocollect such information and assess its effect on the reliability ofclinical data submitted for market approvals. "There is a growing recognition in the academic and scientificcommunities that certain financial arrangements between clinicalinvestigators and product sponsors, or the personal financial interests ofclinical investigators, can potentially bias the outcome of clinicaltrials," said the FDA.FDA spokeswoman Betsy Adams told BioWorld that problematicarrangements would include those giving investigators cash payments,equity investments, royalties or other compensation based on results ofthe clinical studies.Steve Jenning, staff director for the House subcommittee that overseesthe FDA, called the proposed rules "a compromise," adding "We werehoping for something stiffer."Jenning said the House Small Business Subcommittee on Regulations,Business Opportunities and Technology, chaired by Rep. RonaldWyden (D-Ore.), favored limitations on investigators with interests incompanies whose products they were analyzing."Instead of going for absolute thresholds for things like equityinterests, stock or cash rewards, the FDA said [it's] going to mandatethat [investigators] lay everything on the table," he said.The FDA hasn't decided on a threshold financial interest to triggerdisclosure, but Jenning said $5,000 has been discussed.Alan Goldhammer, director of technical affairs for the BiotechnologyIndustry Organization (BIO), said the group's board of directors agreedfinancial disclosure by clinical investigators was appropriate. Theorganization, however, was concerned about implementing rules thatbar scientists from studies."You may be a company working on a very rare disease," Goldhammersaid. "There may be only one or two clinical investigators qualified toconduct the trials and you already could have retained them asconsultants to the company. This would raise you past the threshold fordisclosure. But should we say they can't conduct a clinical trial whenthey are the experts? I don't think we want to do that."BIO President Carl Feldbaum, in a written statement to the FDA on theissue last year, said, "The principal approach to managing bias in aclinical trial is through appropriate study design, monitoring andstatistical analysis."The FDA is seeking written comment from the public for the next 90days on the proposed rules, which were released in the Federal RegisterThursday (Vol. 59, No. 183, pp. 48708-48719). Implementation of therules is expected next year.Under the proposal, companies sponsoring the trials would be requiredto submit the financial disclosure information when they apply tomarket a product. The sponsor would have to either reveal financialinterests or certify that none exist.The rule would not apply to full-time company employees, but toindependent clinical investigators, most of whom are academicians oremployees of contract research organizations."Disclosure and certification requirements," the FDA proposed, "willextend not only to the clinical investigator, but also to the investigator'simmediate family." n

-- Charles Craig

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