What's New in our Spring 2015 Funding Announcements?

Today officially marks the opening of the Spring 2015 Cycle for our five broad PCORI funding announcements (PFAs). In an effort to help you get started, we want to draw your attention to information that is either new for this cycle or will aid you in submitting a responsive application.

Studies in Rare Diseases

PCORI is especially interested in the investigation of strategies that address care for patients with life-threatening or chronically debilitating rare diseases. These illnesses are of such low prevalence—defined as conditions that affect fewer than 200,000 people in the United States (i.e., less than 1 in 1,500 persons)—that special efforts, such as combining data across large populations, may be needed to address them. Our authorizing legislation specifically requires that we have an Advisory Panel on Rare Disease to advise us when such research is performed.

To strongly encourage patient-centered outcomes research focused on rare diseases, we have designated a special pool of $12 million to fund such projects across four of our priority areas. Merit Review of these applications will adhere the standard process (e.g., timeline, criteria, scoring) for the broad PFAs.

Letters of Intent

The required Letters of Intent (LOIs) are reviewed for both responsiveness to the program goals and administrative requirements. As in the last cycle, Fall 2014, the LOIs are competitive and only those researchers whose LOIs are selected will be invited to submit a full application.

During that cycle, we received 828 LOIs, 35 percent of which were invited to submit a full application (see graph). Of the 538 LOIs that were declined, 96 percent were deemed nonresponsive to the program and 4 percent were rejected for administrative noncompliance.

As you prepare your LOI for this cycle, please focus on the following areas.

Responsiveness to Program Goals

We continue to seek to fund research that will inform decisions faced by patients, caregivers, and other stakeholders. Each PFA calls out specific interests for applicants to consider when applying and notes the criteria PCORI will use to evaluate submitted LOIs.

Our funding announcements change cycle to cycle, so applicants should closely review the requirements. In the Spring 2015 Cycle PFAs, we provide greater clarity on the types of programs sought. We’ve also updated the LOI template to provide a checklist that can help you determine whether your proposed research is responsive to PCORI’s funding requirements.

In the past cycle, we continued to receive applications that were nonresponsive due to inclusion of cost-effectiveness in the proposed research. Proposals may measure and report use of health services but, according to our authorizing legislation, may not directly measure costs of care. Your application will be considered nonresponsive if it proposes to:

• Conduct a formal cost-effectiveness analysis in the form of dollar-cost per quality-adjusted life-year to compare two or more alternatives
• Measure the relative costs of care of two or more alternative approaches as the primary criterion for choosing the preferred alternative

According to our authorizing legislation, PCORI does have an interest, however, in studies that address questions about conditions that lead to high costs to the individual or to society. This is included in our review criterion on impact of the condition on the health of individuals and populations. Thus, PCORI is interested in studies that:

• Examine the effect of costs on patients, such as patients’ out-of-pocket costs, hardship or lost opportunity, or costs as a determinant of or barrier to access to care
• Address cost-related issues, such as the resources needed to replicate or disseminate a successful intervention
• Evaluate interventions to reduce health system waste or increase health system efficiency

We also encourage applicants to closely review “Appendix 3: Allowable and Unallowable Costs” in the Application Guidelines. We have provided greater clarity on costs associated with study interventions and patient care. In general, these costs should be covered by the host healthcare delivery system, third-party payer, manufacturer of the product, developer of an intervention, or another interested party. PCORI will consider coverage of the copayment or coinsurance costs of study subjects when necessary to preserve blinding in a study or to ensure that vulnerable populations can participate. If you have any questions about allowable or unallowable costs, please contact our helpdesk by email or phone before the LOI deadline.

Administrative Requirements

Please be sure that you are using the most current (Spring Cycle 2015) LOI templates; all templates have been updated within the Funding Opportunities page. To ensure fairness, PCORI staff will not review LOIs that exceed the stated page limits or include supplemental information that was not requested. You must closely review the formatting and submission guidelines.

Our helpdesk can be reached by email at [email protected] for technical questions and at [email protected] for questions about PCORI research. You may also phone to speak with a member of the science staff (202-627-1884) or receive technical assistance and answers to questions related to the administrative or financial guidelines (202-627-1885).

As always, we would like to hear from you on how we can improve the clarity of our funding announcements and guidelines. Each cycle, we use your feedback to improve the process and make application easier.