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
The Serum Institute of India (SII) expects to soon receive World Health Organisation (WHO) emergency use authorisation for the Oxford University/AstraZeneca Covid-19 vaccine, produced for mid and low-income countries.
According to the deal, Sanofi will gain full global rights to Kymab’s fully human monoclonal antibody, KY1005 that attaches to OX40-Ligand and can potentially treat various immune-mediated diseases and inflammatory ailments.
Moderna tapped veteran Amgen executive Corinne Le Goff to spearhead that effort as chief commercial officer.