PCORI Announces $153 Million in Funding for 35 New Projects
During the July 19 Patient-Centered Outcomes Research Institute (PCORI) Board of Governors meeting, the Board approved $153 million in funding for 35 new projects. This is the largest funding to date for comparative effectiveness research (CER) studies (23% increase) and reflects a higher proportion of studies comparing biopharmaceutical options. Among these studies are research projects focused on treatment-resistant depression, managing and reducing opioid use for chronic pain, treatment for multiple sclerosis, use of new oral anticoagulants, and studies related to the methods for conducting CER. A number of the research projects approved were in response to gaps identified in multi-stakeholder workshops (including patients, providers, payers, and industry representatives) held in 2015. Specific studies that compare two or more medications or medication strategies are listed below.
- Treatment-Resistant Depression
- Switching vs. Augmentation in Treatment-Resistant Depression assesses the effectiveness, safety and tolerability of three treatment strategies: 1) augmentation with an atypical antipsychotic (aripiprazole) 2) augmentation with repetitive transcranial magnetic stimulation (rTMS) and 3) switch to a serotonin-norepinephrine reuptake inhibitor (venlafaxine) among adults with treatment-resistant depression.
- Optimizing Outcomes in Treatment-Resistant Depression in Older Adults compares benefits and risks of adding aripiprazole, adding bupropion, or switching to bupropion. Patients who do not improve will be randomized to switch to nortriptyline or add lithium.
- New Oral Anticoagulants in the Extended Treatment of Venous Thromboembolic Disease
- The Dabigatran, Apixaban, Rivaroxaban, Edoxaban, Warfarin Comparative Effectiveness Research Study (The DARE Warfarin CER Study) compares the rates of major bleeding, blood clots, and death among patients who received extended treatment (≥90 days) with dabigatran, apixaban, rivaroxaban, edoxaban, and warfarin identified using claims and electronic health records.
- The Comparative Effectiveness of Warfarin and New Oral Anticoagulants for the Extended Treatment of Venous Thromboembolism compares the rates of major bleeding, blood clot, death, and patient-reported outcomes among patients with extended blood thinner treatment versus no extended treatment. Among those in the extended blood thinner cohort, new oral blood thinners (dabigatran, rivaroxaban, apixaban, or edoxaban) will be compared to warfarin.
- Treatment of Multiple Sclerosis
- A Multi-centric Randomized Pragmatic Trial to Compare the Effectiveness of Fingolimod versus Dimethyl fumarate on Patient Overall Disease Experience in Relapsing Remitting Multiple Sclerosis: Novel Data to Inform Decision-makers compares the effectiveness of dimethyl fumarate and fingolimod on disease activity and patient-reported outcomes among patients with relapsing remitting multiple sclerosis.
- Rituximab in Multiple Sclerosis—A Comparative Study on Effectiveness, Safety and Patient-Reported Outcomes compares the disability and quality of life of rituximab (as escalation or initial therapy) with either 1) natalizumab and fingolimod in patients with relapsing, remitting multiple sclerosis or 2) interferon beta, glatiramer acetate, and dimethyl fumarate in treatment-naïve patients with multiple sclerosis.
- Randomized, Double-blind, Crossover, Placebo-controlled Trial of Amantadine, Modafinil, and Methylphenidate for Treatment of Fatigue in Multiple Sclerosis compares the effectiveness of amantadine, modafinil, methylphenidate, and placebo to assess the impact on fatigue and other quality of life measures.
- Pragmatic Clinical Studies
- A Randomized Pragmatic Trial Comparing the Complications and Safety of Blood Clot Prevention Medicines Used in Orthopaedic Trauma Patients compares the effectiveness of aspirin and low molecular weight heparin among trauma patients with a significant orthopedic injury to assess the rate of pulmonary embolism, surgical complications, death, and patient-related measures.