Deadline: 31-May-23
The Patient-Centered Outcomes Research Institute (PCORI) seeks to fund rigorous, large-scale pragmatic trials that compare newly available pharmacologic and/or evidence-based nonpharmacologic treatments for the prevention of migraine.
For this funding announcement, applicants may request coverage of patient care costs (including medical products, procedures, and care services) for potential funding by PCORI.
What is the comparative effectiveness of novel pharmacologic and/or evidence-based nonpharmacologic treatments for the prevention of migraine?
- PCORI is particularly interested in studies that compare emerging pharmacological options such as CGRP antagonists to standard prophylactic therapy or to each other. PCORI is also interested in studies that examine the comparative effectiveness of evidence-based nonpharmacological options for migraine prevention. As appropriate, studies may include nonpharmacological interventions as standalone therapy or as an adjunct to pharmacological options.
- Proposed studies should examine large and diverse populations, as appropriate, with an overall sample size that allows precision in the estimation of hypothesized effect sizes. The application must also have planned subgroup analyses aimed at generating meaningful information to inform clinical practice. Applicants should also clearly define criteria for the initiation of preventive therapy based on guideline recommendations.
- Applicants should consider, as appropriate, the full range of clinical and patient-centered outcomes data relevant to patients and other stakeholders. PCORI’s Principles for the Consideration of the Full Range of Outcomes Data in PCORI-Funded Research inform the expectations for applicants and the corresponding evaluation of applications submitted in response to this PFA. Pharmacologic studies should be adequately powered to assess changes in the frequency of headache or migraine days consistent with and/or exceeding prior efficacy trials, while considering evidence gaps regarding long-term effectiveness (follow-up of at least 24 weeks). Other important outcomes of interest include quality of life, headache-related disability, functional impact, tolerability, adverse events, and use of abortive treatment.
Funding Information
- $10 million (not inclusive of patient care cost coverage)
- Maximum Research Project Period 5 years
Eligibility Criteria
- In general, applications for the conduct of research and management of funding may be submitted by appropriate academic research, private sector research, or study-conducting entities. This may include, among others, agencies and instrumentalities of the Federal Government, nonprofit and for-profit research organizations, and colleges and universities.
- Per PCORI’s authorizing statute, every applicant must demonstrate capability to comply with the following conditions:
- abide by the transparency and conflicts of interest requirements that apply to PCORI with respect to the research managed or conducted under contract;
- comply with the PCORI methodological standards adopted by the Board of Governors;
- consult, as appropriate, with the expert advisory panels for clinical trials and rare disease;
- deposit de-identified data from the original research into a PCORI-designated repository to facilitate data sharing, as appropriate;
- have appropriate processes in place to manage data privacy and meet ethical standards for the research;
- comply with the requirements of PCORI for making the information available to the public; and
- comply with other terms and conditions determined necessary by PCORI to carry out the research project.
- Potential applicants are strongly encouraged to review the standard research contract prior to application.
Ineligible
- Individuals are not permitted to apply.
- Foreign Organizations and Nondomestic Components of U.S. Organizations must provide a thorough and thoughtful justification for the research’s ability to benefit the US healthcare system and that the engagement plans include US patients and stakeholders and are relevant to US healthcare system.
For more information, visit PCORI.