DIA – Beginning with the End in Mind – Study Endpoints: Targeting Patient-Centered Outcomes
On March 18 Alan Shields and Ben Banderas from Adelphi Values attended the Drug Information Association’s (DIA) three day conference Beginning with the End in Mind – Study Endpoints: Targeting Patient-Centered Outcomes. Co-led by Linda Deal and Elektra Papadopoulos, presenters included representatives from the FDA and EMA, pharma companies, and health outcomes service providers.
“Developing and advancing a patient-focused, clinical outcome assessment (COA) strategy to support product labelling and promotion requires imagination, early commitment, scientific discipline, and willingness toward open discussion with regulators” said Alan Shields, Vice President at Adelphi Values. “The spirit of this meeting captured those principles and exemplified how, if adhered to, they can have commercial benefit for sponsors and importantly, health benefit to patients.”
Topics ranged from a review of the scientific methods, issues, and execution challenges for internal and external stakeholders to a discussion of the steps needed to achieve labeling and promotion claims. During these discussions the need to have, “endpoint specialists” as part of the drug development team was emphasised. The meeting concluded with a discussion on good measurement principles to ensure that the COA is meaningful, interpretable, and properly documented. Importantly, the FDA emphasised openness in terms of program-level discussion as well interest in discussing novel measurement strategies and methods of development.
Ben Banderas, Senior Research Manager at Adelphi Values noted, “The smaller and intimate nature of the sessions allowed us to gain good insight to the FDA’s current thinking around endpoint development, implementation, evaluation, and documentation. The information taken away will be invaluable to sponsors looking to use COAs in their endpoint strategy, and I think Adelphi Values is in a great position to share that information in both strategic and practical ways to support our clients’ success.”
For additional information please see the DIA meeting webpage
Adelphi Values has been a global leader in patient-centred and healthcare value research for over 20 years. Our in-depth understanding of approaches for the selection, development, validation and implementation of PRO instruments is grounded in a solid understanding of regulatory expectations and standards as well as experience in commercialisation and market access.