NUCOAT’s Planning Phase was a two-year milestone-driven planning phase to inform the development of a Physical Function Clinical Outcome Assessment that will capture physical function limitations across a wide variety of conditions.
During this phase, we:
- Selected six conditions commonly associated with sarcopenia
- Selected five rare disorder conditions
- Conducted a broad literature search and preliminary interviews with patients to determine which of the conditions associated with sarcopenia and rare disorder conditions best represent a wide range of physical function impacts.
- Narrowed down the search to three conditions commonly associated with sarcopenia and three rare disorder conditions, with the intention to include a wide range of physical function impacts
To guide and inform our planning phase, NUCOAT convened three separate groups to provide expertise, insight, and experience:
- The Clinical and Expert Panel (CEP) is comprised of clinicians and renowned experts in kinesiology, health outcomes, patient reported outcomes, occupational therapy, psychology, physical therapy and medical sociology. The CEP provides comprehensive professional guidance for developing NUCOAT’s Physical Function Clinical Outcome Assessment.
- The Stakeholder Engagement Group (SEG) brings together patients, care partners, pharmaceutical representatives, and insurance representatives to encourage the exchange of industry and patient perspectives on the development NUCOAT’s Physical Function Clinical Outcome Assessment and provide a transparent development process.
- The External Technical Advisory Committee (ETAC) consists of a panel of experts who will serve alongside FDA officers to advise NUCOAT on strategic directions, policies and procedures.
During the planning phase, NUCOAT researched six conditions that commonly occur with sarcopenia. The original plan was to narrow down to three conditions associated with sarcopenia to further investigate during the research phase; however, the NUCOAT team and FDA agreed that understanding sarcopenia in older adults would be more valuable to understand physical function limitations rather than to narrow it into sarcopenia in specific diseases.
During the planning phase, NUCOAT also researched five rare disorder conditions. This was narrowed down to three conditions (IPF, Systemic Sclerosis, and Myositis) which will be further investigated during the research phase.
The final conditions have been selected and the NUCOAT Team created an action plan to sustain work on the final Physical Function Clinical Outcomes Assessment beyond the duration of the FDA grant.