Outsourcing-Pharma recently reported the FDA has revised guidance on how its personnel conduct inspections of CROs and sponsors in light of technological advances. It has been ten years since guidance on the topic was first addressed, and since 2001, technology and its impact on clinical research and the way clinical trials are conducted, analyzed and reported on have evolved and revisions to the FDA Compliance Program Guidance Manual have been updated to reflect this evolution.
For example, electronic records and signatures are now covered by the guidance – “whether clinical data are captured on paper, electronically, or using a hybrid approach.” Submission of information to ClinicalTrials.gov is another change. Inspectors must now determine if studies were registered on ClinicalTrials.gov, who entered the information, and whether primary and secondary outcome measures are listed.
Globalization and the increasing number of clinical trials conducted outside the U.S. has also prompted the guidance to include that overseas trials must be compliant with good clinical practice (GCP). And “with the prevalence of multisite clinical trials, traditional monitoring techniques – early and frequent on-site visits at all clinical sites – have become resource intensive,” says the guidance.
Although FDA will not inspect good laboratory practice (GLP) studies at every sponsor/CRO inspection, the possibility exists. And with the new CPGM aiming to significantly change how sponsor, CRO and monitor inspections are conducted, if you haven’t implemented digital practices into your clinical trial services, or are unable to gain real-time access to critical information – it may be time to reassess your operations and add digital, transparent solutions to your shopping list.
What do you think, does revised guidance show new thinking and an effort to redefine outdated industry systems and practices by the FDA? Or do you think the new requirements are more part of an overall effort to silence the ‘noise’ from the over-reporting of adverse events in trials?