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PCORI Finalizes Topics, Timing, and Funding Amount for Upcoming Announcements on Pragmatic Clinical Trials

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Summary

PCORI will fund more head-to-head trials that compare two or more efficacious treatment alternatives for the therapeutic area being examined.
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As noted in a pre-funding announcement updated on Jan. 24, PCORI will accept applications for funding of pragmatic trials twice per year; each cycle will fund six to nine projects at up to $10,000,000 per project.

PCORI is specifically seeking applications for one of 15 priority topics-an increase from the list of seven topics that it identified at the end of 2013. Many of these topics come directly from PCORI’s advisory panels and align with IOM and AHRQ research priorities, signaling continued alignment between PCORI and these organizations and its acknowledgment to build off the research prioritization efforts that have already been done.

Please see list below (* denotes new topic):

(Of note, “Use of antipsychotics in children, adolescents, and young adults” has been removed.)

    Diagnosis and management of bipolar disorder
    Management of breast ductal carcinoma in situ
    Reduction of cardiovascular disease risk in underserved populations such as racial and ethnic minorities and those living in rural communities
    Strategies for preventing the progression of episodic acute back pain into chronic back pain
    Integration of mental and behavioral health services into the primary care of the general population*
    Integration of mental and behavioral health services into the primary care of persons at risk for disparities in health care and outcomes*
    Compare the effectiveness of innovative strategies for enhancing patients’ adherence to medication regimens. Studies should take into account the needs of patients with chronic conditions who are prescribed medications for short- and/or long-term indications*
    Compare the effectiveness of specific features of health insurance on access to care, use of care, and other outcomes that are especially important to patients*
    Treatment strategies for adult patients with migraine headache
    Treatment strategies for symptomatic osteoarthritis, including joint replacement
    Treatment strategies for patients with autism spectrum disorder*
    Strategies for follow-up of pulmonary nodules identified by imaging studies*
    Treatment options for people with opioid substance abuse
    Treatment options for patients with multiple sclerosis*
    Proton beam therapy for patients with lung, breast, and prostate cancer*

PCORI is expected to provide a formal funding announcement in Q1 2014.

To view PCORI’s Pre-Funding Announcement, click here.

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