The U.S. Food and Drug Administration (FDA) just issued a call to industry and other interested parties to weigh in on an important draft guidance, “E8(R1) General Considerations for Clinical Studies.” The draft guidance was prepared under the auspices of the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use. It describes internationally accepted principles and practices for the design and conduct of clinical studies of drug and biologic products.
In addition, the draft guidance provides an overview of the types of clinical studies that may be conducted and data sources used during the product’s life cycle. The draft guidance is intended to promote the quality of the studies submitted to regulatory authorities, while allowing for flexibility, FDA said.
It’s a matter of great interest to many ACRP members. “Over the past few years, we faced several changes in the way clinical trials are performed, whether because of technology evolution or democratization of the notion of quality, which is above all a logical state of mind before a practice, but that will allow us to strengthen the data we obtain from the trials we are involved in,” said Hubert Lesur, CCRC, a Good Clinical Practice and Quality Auditor and President of HL Health Support in France.
The “ACRP member community gathers an incredible amount of people with strong values, from various and different backgrounds, and I really think we can add a brick to the wall of the standards we are working on on an everyday basis,” Lesur said. “Flawed regulations and standards are created by people who do not know what they are dealing with, or sometimes because some stakeholders are more represented than others,” he said.
Lesur issued a call to the ACRP community to ensure its voice is heard. “I have the feeling that in the past, the voice of investigators, clinical research coordinators, or clinical research associates may have been [underrepresented] in regulations and standards definition,” Lesur said. “I truly hope and encourage all of those who are willing to take some time to enrich the discussion on this future content to let us know, and to ensure this update will be suitable to the community needs, and [will allow] improved trials at the lowest risks for patients.”
Author: Michael Causey