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Pharmaceuticals / Regulatory Affairs

Experts Weigh in at FDA Meeting on Patient-Centric Drug Development

Dec. 21, 2017

The FDA invited comments and questions at a public meeting on a discussion document on patient-focused drug development. The document is an early draft for the agency’s planned series of guidances on the topic.

April Naegeli, a research scientist at Eli Lilly, said patients who qualify for clinical trials often are too sick to be able to provide reliable feedback on their experience, so it’s vital in developing strategies for obtaining patient experience data, to understand that recall bias can be a limitation when analyzing a patient population with high unmet need.

The FDA guidance document offers examples for sampling and design methodologies, but it would be more useful to include case study examples as well as “putting the examples more in context of intended use within the medical development process,” Naegeli said.

The agency should consider integrating non-traditional data collection methods such as the use of online research-focused platforms, said Sally Okun, vice president for advocacy, policy and patient safety at PatientsLikeMe, a research platform and patient network. There may not be enough experience using these models for regulatory decision-making, Okun said, but including them would help discover how to best implement them.

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