The Patients’ Academy for Research Advocacy develops educational programs that equip patients and care partners to apply their unique expertise to inform the development of new and better medicines.
We do this because incorporating the lived experience of engaged, aware, and educated patients and care partners is critical to helping drug developers achieve the best results with the medicines they deliver to the public.
We’re not the only ones looking forward to a future in which patients and their care partners are routinely engaged by drug companies, regulators and payers throughout the development and assessment of each new medicine.
The U.S. Food and Drug Administration (FDA) and biopharmaceutical companies developing new medicines have come to recognize that medical products must produce outcomes that are meaningful to patients, and that there is no substitute for patients’ own perspectives on what is meaningful.
Patients were present in the last two negotiations to reauthorize the Prescription Drug User Fee Act (PDUFA), a law that authorizes FDA to collect fees from companies that produce drugs and biologic therapies. As part of the negotiations, FDA made explicit commitments to seek input from patients and develop methods and practices to more comprehensively integrate their perspectives into regulatory decisions.
In addition, the 21st Century Cures Act signed into law in 2016 committed FDA to convene a series of workshops to obtain public input on various aspects of patient-focused drug development, and to publish a series of guidance documents aimed at creating a road map for making patient experience data integral to every phase of medical product development.
Drug companies are indeed beginning to seek patient input into development programs earlier and earlier in the product life cycle. Unfortunately, very few patients and care partners understand the process of researching and developing new therapies. Lack of knowledgeable patients is limiting the amount of direct input into product profiles, clinical trial protocols, outcomes measures, and other aspects of patient-centered R&D.
There are not enough educational programs and tools to build the necessary capacity among patients and care partners. The few education programs developed specifically for patients may be difficult to access due to cost, or because they are offered by a disease-focused group and are restricted to people living with that one disease. Online materials that are more widely accessible are limited in depth and are not truly interactive.
That’s why the Patients’ Academy for Research Advocacy is stepping up with in-depth educational workshops that welcome patients and care partners living with any condition. Our programs prepare patients and care partners to engage in research as full partners who have unique expertise to contribute to the development and assessment of new therapies