The Patient-Centered Outcomes Research Institute has approved $120 million to fund 34 clinical comparative effectiveness research studies on a range of conditions and patient populations.

The new awards include nearly $58.5 million to fund five pragmatic clinical studies that seek to answer important questions about radiation therapy for breast cancer, fractures in older adults, and treatments for children with bipolar disorder and Crohn's disease.

This is the second round of awards made through PCORI's initiative to support pragmatic clinical studies. Such studies are generally conducted in typical clinical settings during routine care and aim to produce results applicable to a broad range of patients and care situations.

Each of the five studies will involve national advocacy organizations, major professional societies and associations, payers, or other key patient and stakeholder groups in their research design and implementation.

[See also: PCORI invests $151M in clinical research.]

"We're excited about the important patient-centered questions that these studies aim to answer," said PCORI Executive Director Joe Selby, MD, in a news release. "We’re also particularly excited about the partnerships that the research teams are forming with key patient groups and other stakeholder organizations. This kind of engagement can lead to greater attention to the outcomes that matter most to patients and those who care for them and foster quicker dissemination and application of study results."

Ranging from $7.9 million to nearly $14 million each, the five pragmatic clinical studies will compare:

• The effectiveness of new proton beam therapy versus conventional photon radiation therapy in treating breast cancer and minimizing collateral damage to healthy organs and tissue.
• Whether healthy lifestyle interventions plus the diabetes drug metformin are more effective than lifestyle interventions alone in reducing weight gain and metabolic problems associated with certain antipsychotic medications among overweight and obese youth with bipolar disorders.
• Whether children with Crohn's disease have better outcomes taking a new biological therapy that targets tumor necrosis factor (anti-TNF) alone or taking a combination of anti-TNF plus a low dose of methotrexate, a conventional drug.
• Whether older adults undergoing surgery for hip fracture have greater likelihood of regaining function and independence and experience fewer complications and less pain if they receive nerve blocking regional anesthesia or general anesthesia.
• The ability of an exercise coaching program versus usual care to prevent further injuries and improve health for older adults who have experienced a low-impact fracture as a result of a fall.

[See also: PCORI antes $120M for clinical research.]

The PCORI board also approved 29 other awards, totaling nearly $61.6 million, under broad funding announcements issued in August 2014 under PCORI’s five national priorities for research. These studies will compare options for improving outcomes for conditions such as opioid addiction, arthritis, stroke, Parkinson disease, leukemia, chronic kidney disease, and child abuse.

The studies will also explore ways to strengthen methods to conduct more rigorous patient-centered clinical effectiveness research and improve patients’ access to care. Several focus on the needs of particular populations, including children, older adults, racial and ethnic minorities, people with rare diseases and individuals with low incomes.

With these new awards, PCORI has approved $854.6 million in funding for 399 patient-centered outcomes research projects since it began funding research in 2012.