AIDS TREATMENT NEWS Issue #208, October 7, 1994
John S. James
The proposed rule would not affect:
* Employees of the pharmaceutical companies sponsoring the trial;
* Investigators running pre-clinical or laboratory studies;
* Investigators running human trials if they are not submitted to the FDA in support of marketing approval for a drug.
Also, the rule would not ban would not ban specified arrangements for compensating investigators, only require their disclosure. (This is important because many small companies are underfinanced, and could not run trials unless they could pay the investigator with part ownership in the company.)
The rule would apply to independent investigators (such as university researchers) who run clinical trials for pharmaceutical companies that are trying to get their drug approved for marketing. When these companies submit their application to the FDA, they will have to identify the investigators involved, and submit one of two forms. One is a simple certification by the company that "(name of company) has not entered into any financial arrangement with any clinical investigator, whereby the value of compensation to the investigator to conduct the study could be affected by the outcome of the study. I also certify that each clinical investigator was required to disclose to (name of company) whether the investigator had a proprietary interest in this product, or a significant equity interest in (name of company), and that no such interests were disclosed. I also certify that the investigator was not the recipient of significant payments of other kinds as defined in 21 CFR 54.2(f)."
The proposed rule rule includes payments to the spouse and dependent children of the investigator, but not to their business partners.
If there are payments as defined above, then instead of the certification, a disclosure statement must be included. If one of the required forms is not submitted, the FDA will not file the application for approval of the drug.
For more information
For an in-depth discussion of the rationale for this proposal, and instructions on how to submit comments, see "Financial Disclosure by Clinical Investigators," Federal Register, September 22, 1994, volume 59, number 183, beginning page 48708.
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