FDA Issues New Guidance for Patient-Centered Drug Development

The U.S. Food and Drug Administration (FDA) recently announced an initiative to better integrate the patient experience into clinical trials. The agency has released the first of four new guidance documents to improve the collection and use of this type of information in product development and regulatory decision-making. The documents were developed with input from patients, patient-advocacy groups, and clinicians from more than 20 disease areas.

The first guidance, “Patient-Focused Drug Development: Collecting Comprehensive and Representative Input,” provides recommendations about effective approaches for obtaining patient input, standardizing data collection, and implementing these approaches into routine biologic and drug development.

“Our work demands that we must continue to reflect on how we can make the science of drug development and review more modern and more patient-centered, so that approved products impact the metrics that real-world patients and families value most,” FDA Commissioner Scott Gottlieb, MD, said in a press release announcing the new guidance documents.

As part of its patient-focused drug development initiative, the agency plans to release three additional guidance documents:

  • Guidance 2 will discuss methods for obtaining information from patients and gathering information about issues important to such patients.
  • Guidance 3 will cover the development of “fit-for-purpose clinical outcome assessments” to appropriately measure patient-experience data.
  • Guidance 4 will discuss patient-experience data interpretation and the development of endpoints that reflect patients’ priorities.

There is no public timeline for the release of these supplemental guidances, but the public comment period for the first draft guidance is now open.

Source: FDA news release, June 12, 2018.