|Letters of Intent were due Tuesday, February 13, 2018, by 5:00 p.m. ET.
Those selected to submit a full application were notified by Wednesday, March 14, 2018.
Full applications were due Wednesday, May 16, 2018, by 5:00 p.m. ET.
The Patient-Centered Outcomes Research Institute (PCORI) seeks to fund high-quality clinical studies that compare the effectiveness of two or more pharmacological treatments for moderate to severe anxiety in children, adolescents, and/or young adults (e.g., comparisons of shorter-acting to longer-acting selective serotonin reuptake inhibitors (SSRIs) or comparisons of SSRIs to selective serotonin norepinephrine reuptake inhibitors (SNRIs)); pharmacological treatments should be delivered in conjunction with cognitive behavioral therapy (CBT) or another evidence-based psychological intervention.
For this PFA, PCORI is broadly interested in comparisons that are relevant and applicable to patients in the age range of 7 through 25 years; this age range represents a spectrum of developmental stages. Applicants will be asked to clearly define the specific age range to be studied, and to provide a scientific rationale justifying the coherence of the proposed study population, in terms of age, disease severity, proposed intervention approaches, and analytic plans.
Each proposed comparator must be clearly defined, evidence-based, and widely available, and applicants should ensure that all comparators are appropriate for the age range and disorder severity of the study population. Studies must include a minimum follow-up period of one year from baseline; two years of follow-up from baseline is 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 proposed primary analyses and subgroups as appropriate to the proposed population.
Note that this funding program does not support applications to conduct cost-effectiveness analyses, systematic reviews (with or without meta-analyses), or developing or evaluating shared decision-making or decision-support tools. In general, PCORI will not cover costs for interventions that are being compared in the proposed study (See Appendix 3 in the Application Guidelines for details).