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Treatment of Multiple Sclerosis - Cycle 3 2016
This Notice encourages research institutions or consortiums of institutions with expertise in comparative clinical effectiveness research (CER)/patient-centered outcomes research (PCOR), and in clinical research related to the treatment of multiple sclerosis (MS), to consider applying for this re-opened PFA.
The Patient-Centered Outcomes Research Institute (PCORI) seeks to fund randomized clinical trials (RCTs) or large observational studies that compare two or more alternative clinical strategies for treatment of MS that address the following questions:
- What are the comparative benefits and harms of different disease-modifying therapies (DMTs) or therapeutic strategies in patients with relapsing, remitting multiple sclerosis on symptoms, functioning, quality of life, disease activity, and disease progression? Strategies may include comparisons of initial DMT treatment or comparisons of follow-on treatments in patients for whom initial DMT treatment has failed, including strategies for sequencing or combining agents, changing to a different DMT, or escalating DMT dose.
- What are the comparative benefits and harms of different approaches, other than DMTs, for ameliorating important symptoms in people with MS? Symptoms of interest include fatigue, difficulty walking, memory or attention problems (cognition), bladder problems, numbness or tingling, and pain. Studies of patients with progressive forms of MS are of particular interest.
- What is the comparative effectiveness of telerehabilitation vs. conventional direct care interventions for improving outcomes in people with MS, such as functional status, fatigue, and quality of life?
Deadline for Letter of Intent: Nov. 1, 2016
Applications may be submitted by any private-sector research organization, including any non-profit or for-profit organization, and any public-sector research organization, including any university or college hospital or healthcare system, laboratory or manufacturer, or unit of local, state, or federal government. The Internal Revenue Service must recognize all US applicant organizations. Nondomestic components of organizations based in the United States and foreign organizations may apply, as long as there is demonstrable benefit to the US healthcare system and US efforts in the area of patient-centered research can be clearly shown. Organizations may submit multiple applications for funding. Individuals are not permitted to apply.
Question 1 - $10 million; Question 2 - $3 million; Question 3 - $5 million