Patients are the pharmaceutical industry’s raison d’etre. New FDA draft guidance is designed to help move patients closer to the heart of the drug development process.
A long time coming
In the late 1980s, faced with a growing health crisis, patients with HIV/AIDS demanded a seat at the table. The patient advocacy group soon expanded to include cancer and other special health issues, and in 1991, the first patient representative sat on the FDA Advisory Committee. In the three decades since, patients groups have played an increasingly important role. In June the FDA rolled out Patient-Focused Drug Development: Collecting Comprehensive and Representative Input. The draft is the first of four guidance documents planned under the 21st Century Cures Act.
What’s in the first guidance
The 65-page draft document outlines ways that pharmaceutical and biotech manufacturers can include patient experience data in their development programs. It addresses who information should be gathered from and how, and it recommends qualitative and quantitative research methods for analyzing the data. It also provides guidance on standardizing data collection and data management.
What else you need to know
Industry innovators have been collecting patient experience data directly through patients by means other than patient-reported outcomes (PROs) long before the FDA issued the draft guidance. They understand the value of patient experience data to their commercial, clinical and medical affairs teams. Yet Clinical SCORE research indicates that the majority — about 75 percent — of those surveyed are just beginning to become patient-centric or are only patient-centric in a few departments.
In this case, the leaders and innovators have a significant business advantage. They understand:
- How various departments benefit from patient experience data collected during clinical trials
- At what point each department derives the most practical benefits from patient insights
- How to obtain company-wide support for patient-centricity initiatives
How you can learn more
Clinical SCORE recently hosted an educational webinar, Navigating New FDA Draft Guidance on Patient-Centricity: What You Need to Know.The expert panel included Deborah Neville, former director, Global Patient Support Solutions, Teva; James Riddle, vice president, Client Services, Kinetiq; and Ross Weaver, managing director and founder, Clinical SCORE. For more information, view the presentation on demand or call Blaine Cloud at (877) 343-0100, ext. 1005.