FDA Seeks Reliable Patient Information to Support Regulatory Decisions
As FDA continues to advance the role of patients in designing clinical trials with meaningful and accurate endpoints, it is seeking more input from stakeholders on how best to identify clinical outcomes most important to patients and caregivers.
As FDA continues to advance the role of patients in designing clinical trials with meaningful and accurate endpoints, it is seeking more input from stakeholders on how best to identify clinical outcomes most important to patients and caregivers. The aim is to reduce uncertainty about the reliability of patient reported outcomes (PROs) and encourage the sustained use of patient experience data in drug development. More consistent standards and new FDA guidances should make it “standard practice” to incorporate patient experience in drug development and regulatory decision making, says Theresa Mullin, Associate Director for Strategic Initiatives, who heads up the Patient-Focused Drug Development (PFDD) program at the Center for Drug Evaluation and Research (CDER).
To advance this initiative, FDA officials will discuss best practices for collecting comprehensive and representative patient input, methods for identifying what’s most important to patients, and selection of fit-for-purpose clinical outcomes assessments (COAs) with patients, sponsors, the research community, and others at a public meeting October 15-16, 2018 [see
Mullin described at the DIA conference how FDA is developing four methodological PFDD guidance documents to clarify how to collect and submit patient experience data, as authorized by the 21st Century Cures Act to help advance medical product development and regulatory decision making [see
To help stakeholders prepare for the October public meeting, FDA has issued two discussion documents and background information on methods for identifying what’s most important to patients [see
Jill Wechsler is the Washington Correspondent for Applied Clinical Trials.
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