The comments come as the US FDA last week announced that it was re-opening the comment period for the notice regarding the release of such data. Comments will now be received through the end of October.
The FDA published a request for public comments from interested persons on the proposed availability of de-identified and masked data derived from medical product applications.
In its notice, the agency requested comment on:
- What factors should be considered in masking study data;
- What limitations, if any, should there be on the FDA's ability to make available the masked data;
- Are there any additional factors FDA should consider in de-identifying data in addition to FDA's requirement to remove any names and other information (e.g., birth date, death date, local geographic information, contact information) that would identify patients or research subjects before disclosing information;
- Would regulatory changes facilitate implementation of such a proposal, and if so, what changes would be most useful; and
- Which situations do you believe disclosing masked data would be most useful to advance public health?
Despite the encouragement from Quintiles, the CRO (contract research organization) says it’s “concerned” about limits on the data and that it would be “unconscionable for the Agency to make such data available to the public.”
The company says the data should only be allowed for release to “qualified researchers undertaking IRB-approved projects.”
Novartis echoed Quintiles’ sentiments, noting that the release of masked and de-identified data “should be limited to regulators, such as the FDA, or bona fide researchers (individuals, academic institutions, consortia etc.) with a viable proposal for research that is intended to contribute to public health, as determined by FDA or an independent body of experts appointed by FDA.”
Twenty-nine other companies, such as Roche; industry associations, such as the Association of American Medical Colleges, and individual researchers also already commented on the questions posed by the FDA.
The FDA announcement comes as the EMA (European Medicines Agency) announced it has closed its comment period for a draft policy outlining rules for publication and access to clinical-trial data submitted as part of a marketing-authorisation application.