(Newswire.net — January 7, 2019) — The Food and Drug Administration has challenged drug sponsors to develop new ways to discover and collect patient data that can be used to bring patients into clinical trials that do not sacrifice the patient’s safety or privacy. The FDA released an early draft in late December encouraging sponsors to propose their own guidelines.
They ask that these proposed guidelines should pinpoint specific points in the treatment process of in the life cycle of a medical device that might be informed by the patient’s experience.
The 12-page memorandum says drug sponsors who wish to take them up on the idea are advised to consider whether or not they already have the requisite expertise in areas such as natural history studies, patient registries, coordination between patient advocacy groups and regulators and trials officials.
The FDA’s guidance paper includes the following indications when a sponsor should consider developing new ways to discover and collect patient data:
‘When clinical guidance already exists in a disease area, but it does not address the needs of specific populations. When there is methodological guidance- like adaptive trial designs- but sponsors lack specific ideas on how methods might be applied to a given disease or subpopulation; and when there may be a need for disease-specific guidance which the FDA has not yet addressed.’
Mark Summers, the president of patient engagement at WCG Clinical commented, “No one in the clinical research industry is looking for more work to do,” he says. “But I think the idea is a good one. We want to ensure the information is standardized as much as possible.”
He comments on one of the most well-known problems in measuring patient outcomes, that of subjectivity, saying that on the pain scale, one person’s four is another person’s seven.
The founder of the Lazarex Foundation, Dana Dornsife said, “It reflects a new attitude at the FDA. It’s a great development for patients. I think what they’re doing is trying to create organization around what at this time is a chaotic phenomenon- all these big data projects. Everybody’s collecting data, but no one has any idea what do to do with it? We don’t want to walk away from promising treatments. But this opportunity doesn’t reflect our larger society.”
After new guidelines are proposed, the FDA will open the given case up for public comment. For the time being, the agency will not issue its own guidance.