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Are there additional requirements for Category 2 LOIs/Applications?

If requesting a budget with direct costs over $5 million, up to a maximum of $10 million, applicants must highlight and justify the need for the requested material and personnel resources to support the scale and scope of the proposed study.  Potential examples include scale and scope requirements to achieve the following: inclusive, diverse, and representative participation by patients, study sites, care-delivery environments, disadvantaged patients, communities, and geographic areas; planned subgroup analyses to provide meaningful information to inform clinical practice; or planned analyses accounting for adaptations associated with pragmatic study design and conduct. 

Category 2 applications must:

  • Examine large and diverse populations as appropriate with an overall sample size that allows precision in the estimation of the hypothesized effect sizes. The application must also have planned subgroup analyses aimed to generate meaningful information to inform clinical practice.
  • Make use of multiple study sites offering care reflective of the diversity of US health care. Applicants proposing studies with more than $5 million in direct costs will be considered nonresponsive if only a single study site is proposed.

Please refer to the PFA for additional review considerations that will be applied to Category 2 submissions.

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