The US Food and Drug Administration (FDA) is announcing a new push towards modernization, particularly in the form of integrating electronic solutions into multi-center trials. Rather than paraphrase, we’ll just let them lay out the facts…
The Human Subject Protection and Bioresearch Monitoring (HSP /BIMO) Initiative will facilitate the modernization of the regulation of clinical trials and bioresearch monitoring, specifically the protection of human subjects and the integrity of data in clinical trials, and encompasses devices, foods, human drugs, biological drug products and veterinary medicine.
Highlights of what has been completed to date include:
* Draft Guidance; Process for Handling Referrals to FDA Under 21 CFR 50.54; Additional Safeguards for Children in Clinical Investigations, published May 2006
* Guidance for Industry – Using a Centralized IRB Process in Multicenter Clinical Trials, published in March 2006
* Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees, published in March 2006
* Information Sheet Guidances for IRBs, Clinical Investigators, and Sponsors, five published in final January 2006
Projects in progress:
* Modernizing adverse event reporting to institutional review boards (IRBs) to accommodate major trend toward multicenter trials (March 2005, held Part 15 Hearing – Adverse Event Reporting to IRBs, currently working on draft guidance)
* Published proposed rule: Institutional Review Board – Registration Requirements, FDA reviewing comments
* Finalizing rule: Foreign Clinical Studies not Conducted Under an IND (21 CFR 312.120)
To be honest, much of what’s contained in their press release lays out objectives which seem like they should already be concerns for the FDA. Also notably lacking is any specific reference to the medical device world, regulated by the FDA’s Center for Devices and Radiological Health (CDRH).