Outourcing-Pharma focus on: FDA clinical trial initiatives
FDA revamps its approach to clinical trials monitoring
new policy and regulatory developments to modernise the way it
monitors clinical trials and bioresearch.
Dubbed the Human Subject Protection and Bioresearch Monitoring (HSP/BIMO) Initiative - the new regulatory tweaks will apply to the agency's inspections in the areas of pharmaceuticals, biological drug products and medical devices.
The agency's efforts are part of an initiative by the Department of Health and Human Services (HHS) to employ recent advances in basic science, including genomics and molecular analysis, in order to bring about more effective development and review of new therapies.
"The new policy and regulatory developments will strengthen the oversight and protection of patients in clinical trials and the integrity of resulting data," said a statement from the agency.
Clinical trials have evolved dramatically since the FDA first began inspecting them in 1977 and current compliance programs that provide guidance for inspections of investigators, sponsors, contract research organisations (CROs), institutional review boards (IRBs) and bioequivalence facilities are outdated.
"As clinical trials continue to evolve in both size, complexity, the use of technology and global location, the FDA's approach to monitoring must also evolve and modernise," said Janet Woodcock, FDA deputy commissioner for operations at this year's Drug Information Association (DIA) annual meeting.
Over the past year and a half, the FDA said it has carefully inventoried its programs and identified issues to launch the HSP/BIMO Initiative and said it will continue to welcome additional input from the industry as the initiative moves forward.
The FDA said that the following updated guidances that have 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Draft Guidance: Process for Handling Referrals to FDA Under 21 CFR 50.54; Additional Safeguards for Children in Clinical Investigations - published in May 2006.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 - published in January 2006.
The agency also indicated that the following are projects that are still in progress:
Draft Guidance: Adverse Event Reporting to IRBs - held Part 15 Hearing in March 2005.
Published proposed rule: IRB Registration Requirements - FDA reviewing comments.
Finalising rule: Foreign Clinical Studies not Conducted Under an IND (21 CFR 312.120).
The HSP/BIMO Initiative is one of a number of attempts that the FDA is making in order to revamp its regulatory kudos.
The agency recently announced that a series of changes to the way it evaluates clinical trials in new drug applications (NDAs) are imminent in an attempt to clamp down on clinical trial fraud.
In addition, the government agency has also signalled it will soon allow a new "adaptive" approach to clinical trials, offering sponsors the flexibility to examine early results of a trial half way through and modify the trial design in order to streamline drug testing and speed drugs to market.
