Awards Include $56.7 Million for New Pragmatic Studies, $9 Million for PCORnet Obesity Studies
For Immediate Release
Patient-Centered Outcomes Research Institute
WASHINGTON, DC (August 18, 2015) — The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors today approved $56.7 million for four large patient-centered studies of treatment options for appendicitis, ways to improve behavioral and mental health care, and options to prevent potentially deadly blood clots in patients getting hip and knee replacements.
The four awards approved today are the latest in PCORI's initiative to support “pragmatic clinical studies.” These are conducted in typical clinical settings, rather than in specialized research centers, and involve participants who more closely mirror typical patients.
The Board also approved $9 million for two studies on obesity, one on weight loss surgery and the other on weight gain that may be caused by antibiotic use among young children. These are the latest studies designed to demonstrate the capacity of PCORnet, the national clinical research network PCORI is developing to help the nation conduct studies faster and more efficiently than traditional research approaches.
In addition, the Board approved the development of new research funding announcements offering up to $60 million to support comparative clinical effectiveness (CER) studies on two important topics -- use of new anticoagulant drugs and care for treatment-resistant depression.
The pragmatic studies PCORI is funding aim to produce results that are more relevant to a broad range of patients and care settings and easier to adopt in routine clinical practice. The newly approved awards will support studies comparing:
- the safety and effectiveness of antibiotics versus surgery in treating patients with uncomplicated appendicitis.
- the safety and effectiveness of three blood-thinning drugs used to prevent potentially deadly blood clots in patients undergoing hip and knee replacement.
- different approaches to getting patients with post-traumatic stress disorder and bipolar depression the mental health care they need.
- two strategies for getting patients in rural and underserved areas the behavioral health care they need to see which works better.
Each study will involve national advocacy organizations, major professional societies and associations, payers, and other key patient and stakeholder groups in their research design and implementation. More details on each project can be found on PCORI’s website.
“These studies will answer important patient-centered questions that matter to patients and those who care for them,” said PCORI Executive Director Joe Selby, MD, MPH. "They will do so in a way that their results will be more immediately and directly relevant to all patients with these conditions and who need the information to make better-informed decisions about their healthcare options."
All of the projects have been approved by the Board pending completion of a business and programmatic review by PCORI staff and issuance of formal award contracts. With these awards, PCORI has now approved or awarded nearly $1.08 billion for research projects and other initiatives that will help patients and those who care for them make better-informed healthcare choices.
With the Board’s approval, PCORI expects to issue new calls for proposals this fall to provide up to $30 million for studies comparing the effectiveness of new blood-thinning drugs in treating blood clots and up to $30 million for research on treatment-resistant depression
These topics were the focus of multi-stakeholder workshops PCORI convened in June. PCORI applied the input from these workshops to refine the research questions to be included in the forthcoming funding announcements.
“We’ve benefitted greatly from the perspectives of patients, clinicians, family caregivers, health plans, the life sciences industry, and others in helping us to identify key evidence gaps on conditions that greatly affect individuals and families and to refine the questions that will be the focus of our funding opportunities,” said Jean Slutsky, PA, MSPH, PCORI’s Chief Engagement and Dissemination Officer and Program Director for Communication and Dissemination Research.
Fact Sheet: Pragmatic Clinical Studies Initiative
The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work.
PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct comparative clinical effectiveness research efficiently by creating a large, highly representative network for conducting clinical outcomes research that directly involves patients in the development and execution of the research. More information is available at www.pcornet.org.