Notice of Upcoming PCORI Funding Announcement (PFA)

Research Initiative Highlights

The Patient-Centered Outcomes Research Institute (PCORI) has had an ongoing interest in funding high-quality clinical studies that compare the effectiveness of evidence-based clinical strategies to treat anxiety disorders in children, adolescents, and/or young adults. PCORI intends to release a new funding announcement for this topic in January 2019. Clinical strategies to be studied may include pharmacological interventions, psychological interventions, or a combination of both. Each proposed comparator must be clearly defined, evidence-based, widely available, and appropriate for the age range and clinical severity of the study population.

The proposed study population should include patients with a confirmed clinical diagnosis of a primary anxiety disorder and who are between 7 and 25 years of age. Applicants must clearly define the specific age range to be studied and provide a scientific rationale for the proposed study population and interventions. Applicants should consider several factors when defining their study population, including but not limited to: anxiety severity, type(s) of anxiety disorder(s), exposure to previous treatment(s)/treatment failure, recurrent or relapsed illness, and/or subpopulations.  Studies should be conducted in well-defined, primary, specialty and/or integrated clinical care settings where psychological services are consistent and well-characterized.

Randomized controlled trials that compare the effectiveness of treatments are encouraged. Prospective, observational cohort studies that focus on assessing the heterogeneity of treatment effects and/or the comparative tolerability and safety of drugs may also be proposed. All studies should include outcome measures to assess function, symptoms, acceptability of treatment, and the measurement of adverse effects. Studies with a minimum follow-up period of nine months from baseline are sought, with one year of follow-up preferred. In addition, all studies funded through this initiative must include robust sample sizes of at least 300 participants, with sufficient power demonstrated to conduct the proposed analyses.

The maximum project budget is $5 million in direct costs, with a maximum project duration of 3.5 years.

This PFA preannouncement is provided to allow potential applicants additional time to identify collaborators, obtain stakeholder input on the research question, and develop responsive, high-quality proposals. Further details will be available in the full announcement to be released on January 3, 2019.