PCORI Funding

The Patient-Centered Outcomes Research Institute (PCORI) has recently announced a funding opportunity that will provide $10 million in direct costs for studies up to five years long that compare the effectiveness of multimodal pharmacologic and/or nonpharmacologic interventions to prevent fractures in people with osteoporosis and a history of a fracture. While evidence exists for single interventions, broad evidence gaps exist around combination interventions to prevent second fractures.

PCORI is interested in comparing combinations and/or sequences of interventions that are either in common use, have suggested efficacy, or have strong theoretical underpinnings. Regardless, proposed combinations or sequences of interventions should address actual clinical choices or dilemmas faced by patients, caregivers, and clinicians in specific practice settings.

Question of Interest

What is the comparative effectiveness of multimodal treatment interventions (i.e., combination of pharmacologic and/or non-pharmacologic) on patient-centered outcomes in people with osteoporosis and a history of fractures?

Population

Studies should focus on postmenopausal women and on men with osteoporosis and a history of fracture. Underrepresented groups from previous studies (e.g., men and women in racial/ethnic groups other than Caucasian) are of particular interest.

Interventions/Comparators

Head-to-head comparisons of evidence-based interventions that target prevention of osteoporotic fractures

Outcomes

Fractures, validated measures of pain and functional status, functional independence, institutionalization, quality of life, and other outcomes important to clinician and patient shared decision making

Funding

Total allocated for this PFA: Up to $40 million in total costs
Total direct funding: $10 million

Maximum project duration

Five years

Important dates

September 7 – Applications open
September 14 – Town Hall
October 5 – Letters of Intent due
January 11 – Applications due
April 2022 – Merit review
July 2022 – Awards announced
November 2022 – Earliest start date

For more information or to request a brief consultation, please contact Leslie MacGregor, PCORI Funding Specialist: Leslie_MacGregor@hms.harvard.edu