The FDA is polling the industry and the public for ideas on where the agency should focus when it comes to addressing patient preferences for medical devices, to help build out its new list of priorities that could impact the structure of premarket clinical studies, risk-benefit assessments and postmarket reviews.
Awareness of patient preferences can also be applied in the design of the device itself, of course, and the FDA hopes to identify the key areas where deeper knowledge would have the largest impacts—such as in how patients may value the benefits and risks of a certain technology or treatment differently from healthcare professionals and caregivers.
“Patients are the experts in living with their disease or condition, the outcomes that are most important to them, and how they weigh benefits and risks,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in an agency statement.
“Through better collection and understanding of information that matters to patients, we can ensure our evaluation throughout the lifecycle of a medical device includes a better reflection of the patient experience,” Shuren added. There may also be areas were population-level differences in perspective could be better understood.
To start, the agency has published an initial list of priority areas culled from previous public input the FDA has received through workshops and other avenues. It includes descriptions of patient values in diagnosis and treatment, as well as relevant clinical endpoints for specific populations.
It also lists preference-sensitive areas organized by medical specialty—for example, the tradeoffs between risks and benefits when operating diagnostics at the point-of-care compared to other venues or whether incremental increases in cancer survival always outweigh the risks of device-related toxicity.
The FDA has also opened a docket for public comments on whether any changes should be made to the list, and is seeking information on existing studies in the field to help it address the issue.
“By asking patients, industry members and researchers to provide comments and feedback on this list, we’re working to ensure that the valuable insights from patients continue to inform the agency’s decisions and understanding,” Shuren said.
By Conor Hale
Source: Fierce Biotech
Giovanni Caforio, the former CEO of Bristol Myers Squibb, is set to become the next board chairman of Novartis, which on Tuesday proposed the pharmaceutical industry veteran as its pick to replace Joerg Reinhardt in the role next year. Reinhardt has served as Novartis’ chair since 2013 and plans to retire when his 12-year term ends in 2025.
GE HealthCare has raised the curtain on two ultrasound systems equipped with artificial intelligence programs designed to assist in diagnosing conditions in women’s health, including obstetric exams. The Voluson Signature 20 and 18 imaging systems include AI tools capable of automatically identifying and annotating measurements of fetal anatomy.
Scientists from the University of Edinburgh’s School of Chemistry have revealed a new sustainable method of manufacturing complex molecules that could reduce waste produced during drug production. The method published in Nature Chemistry could help to prevent severe side effects caused by drugs that can exist as enantiomers.
