Bold, innovative, and large-scale clinical trials carry some risk of failure along with their potential benefits. To be scientifically and fiscally responsible in balancing the potential for risk as well as reward, PLACER will use a phased funding approach new to PCORI: an initial planning phase will determine if the trial is feasible and can achieve its intended aims as planned. If careful review of the planning phase accomplishments indicates likely success of the full-scale trial, continued study conduct and funding will proceed.
We believe this phased approach will result in successful completion of greater numbers of large and impactful studies and increase PCORI funding of more researchers. This blog provides more information about the funding opportunity, and we encourage interested researchers to attend the town hall for applicants on July 14.
Update (July 16, 2020): You can now watch the archived applicant town hall webinar here.
- Feasibility phase: $2 million in funding per project, up to 18 months in duration
- Full-scale study phase: $20 million, up to five years in duration
- Total funds available: $150 million
Key Dates and Deadlines
- Town Hall for potential applicants: July 14, 2020
- Letters of Intent due: September 29, 2020
- Applications due: January 12, 2021
- Awards announced: July 2021
- Earliest start date: October 2021
The Two Phases of Funding Explained
PLACER represents the culmination of examining data and lessons learned from our investment in more than 40 pragmatic clinical studies (PCS), feedback from funded PCS researchers, and input from our Advisory Panel on Clinical Trials and Board of Governors.
In the first phase, funding of up to $2 million will provide awardee teams time to establish the trial’s design, operations, infrastructure, and analysis plan. Researchers in this phase will engage stakeholders to refine and prioritize study questions, agree on study design and data collection methods, assess the ability of clinical sites to implement the study interventions, and establish guidance on how to balance real-world flexibility while preserving the core functions of the study. This phase will also provide data to understand the study’s potential to provide important, actionable information to guide individual healthcare choices. Finally, the first phase of funding will allow preparation for a smooth launch of the study in phase two, including pilot testing of participant recruitment and other important study operations.
The initial research planning and feasibility phase will progress to full study operations only if pre-established rigorous milestones and criteria are met. This decision, made by PCORI’s Executive Director, will be based upon rigorous review that will include experts from an external multidisciplinary advisory panel.
Funding for phase two, which can last up to five years, is up to $20 million per project. A total of $150 million is available for this PCORI Funding Announcement.
Complex, High-Burden Questions That Patients Face
PCORI seeks to fund trials that compare two or more alternatives that represent a critical choice for patients, caregivers, clinicians, and other healthcare stakeholders as evidenced by gaps identified in clinical practice guidelines and systematic reviews.
Research topics selected for this funding announcement should be complex and represent a significant burden on the national population. Example topics for studies that could meet the size and scope requirements for PLACER include osteoporotic bone fracture, migraine prophylaxis in adults, improving outcomes in maternal morbidity and mortality, prevention of suicide in youth and young adults, and optimal systolic blood pressure target in older adults. These are not explicit PCORI priorities but are examples of the complex scope and scale of the questions this funding mechanism seeks to answer. More information is available in the funding announcement.
PLACER in the Context of the Novel Coronavirus
Any health research opportunity in 2020 would be incomplete without acknowledging the COVID-19 pandemic. Substantial uncertainties exist about the nature and duration of its impact on research. PCORI considers the safety and well-being of study participants, research staff, and stakeholders to be paramount and advocates that safety be the foundational principle guiding research decisions.
As outlined earlier in this piece, PCORI is receptive to Letters of Intent to PLACER encompassing a wide range of investigator-initiated research supporting comparative effectiveness. This may potentially include research related to COVID-19 and its impact on health. We note with caution, however, that the size and expected timeframe for PLACER studies to generate research results does not readily fit the urgency of finding effective solutions to the COVID-19 pandemic. Please visit our COVID-19 Updates webpage to stay updated on PCORI’s response to the pandemic.
Letter of Intent Deadline in September
We are very excited about this ambitious funding opportunity, which will allow us to foster large, meritorious, and innovative studies with some risks, increase PCORI funding that directly compares clinical and care delivery options, and improve research success and impact by purposefully addressing the many risks of large research investments. We invite interested researchers to send any questions to [email protected] and to submit Letters of Intent to PCORI by September 29, 2020.