The FDA agency is streamlining how it reviews and approves drugs, tests, and medical devices.
“We are at an inflection point when it comes to the reductionist design process [of trials]” FDA’s Frank Weichold, MD, Ph.D. said. The agency is moving towards a more holistic approach and wants future trials to consider study design and timeline in regards to the objectives and more flexibility.
Weichold envisions a world in which patients willingly and freely share comprehensive health data in a standardized format. As idealistic as it sounds, he said, there was precedent: Some European countries have had a measure of success creating such systems. He also mentioned the OneSource program, an effort to give patient-centered outcomes researchers access to a cloud-based data set while cutting down on duplicate data entry.