FDA ups its vigilance on clinical investigators
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The agency said this final rule is based on previous recommendations made by the Government Accountability Office (GAO). The rule's goal will be to protect research subjects and the quality of data submitted to the agency.
“FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted,” according to the April 30 Federal Register.
The GAO made the following recommendations:
- FDA extend disqualification by a commissioner’s decision to include ineligibility to receive unapproved drugs, biologics and medical devices; and
- FDA take action to prevent clinical investigators who engage in serious misconduct from doing so again, whether in research that involves drugs, biologics or devices.
The final rule took GAO recommendations into account and will also work to prevent clinical investigators who are disqualified by the commissioner to conduct clinical investigations that support an application for a research or marketing permit for FDA-regulated products.
Previously, FDA clarified the rule to eliminate unnecessary language. As it stands now, the language reads: “If an explanation is offered and accepted by the applicable center, the center will discontinue the disqualification proceeding.
“This final rule helps to protect the rights and safety of subjects involved in FDA-regulated investigations,” according to the statement.
The final rule was open for comment. In the comment period, FDA received two comments: one from a healthcare professional and the other from a regulated industry. Both supported FDA’s proposal to ensure data integrity and quality.
The comment from the regulated industry asked that the FDA clarify or define the terms “repeatedly or deliberately” or remove the language. In addition, the regulating body asked the FDA to clarify how much data or what frequency constitutes “repeatedly.”
In FDA’s response, the agency said that “repeatedly” means “more than once.” Additionally, the agency said that it would consider disqualification if a clinical investigator commits a regulatory violation more than one time during a single study or one time in each of two studies (i.e. “a study subject who was ineligible because of a concomitant illness putting the subject at greater risk.”)
The agency said that the term “deliberately” would occur in a case where an investigator demonstrated “reckless disregard,” or if an investigator failed to comply with regulations.
If a clinical investigator is in fact disqualified, FDA will post the investigator’s name and date of disqualification on its website. Also, it will notify the study sponsor and institutional review board in writing of the disqualification.
FDA estimated that there is on average one matter per year in which clinical investigators are deemed disqualified via the commissioner’s decision. “We do not expect that this final rule will impose additional costs,” the agency summed.