Reopened PCORI Funding Announcement

Research Initiative Highlights

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:

1. 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.
2. 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.
3. 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?

Background

PCORI’s mission is to improve the quality and relevance of evidence available to help patients, caregivers, clinicians, employers, insurers, and policy makers make informed health decisions. Specifically, we fund CER and work that will improve the methods used to conduct such studies. 

PCORI relies on input from multiple stakeholders to set its research priorities. Members of its advisory panels include patients, clinicians, researchers, purchasers, payers, industry, and other healthcare stakeholders. Stakeholders identified the treatment of MS as an important topic based on the lack of evidence available to help patients and other stakeholders choose among care strategies. PCORI’s Advisory Panel on Assessment of Prevention, Diagnosis, and Treatment Options ranked treatment of MS as high-priority. PCORI convened a large multi-stakeholder workshop, to provide further input on whether specific CER questions could be addressed by PCORI-funded research – see http://www.pcori.org/events/2015/prioritizing-comparative-effectiveness-research-questions-treatment-multiple-sclerosis. Through further stakeholder engagement and discussions with PCORI’s Science Oversight Committee, three high priority areas were proposed, and PCORI funded four projects in its funding Cycle 3 2015.

The reissue of this targeted funding announcement reflects the significant policy importance and the crucial need for evidence regarding the comparative effectiveness of different treatment strategies for patients with multiple sclerosis.