PCORI is accepting Letters of Intent throughout the summer for a new research initiative to fund large, compelling clinical trials in comparative effectiveness research (CER). Trials funded through this initiative—Phased Large Awards for Comparative Effectiveness Research, or PLACER—will examine patient-centered outcomes in answering research questions on high-burden, high-impact health topics in real-world clinical settings that reflect how most American health care is delivered.
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.
Two Phases Explained
PLACER represents the culmination of examining data and lessons learned from PCORI's investment in more than 40 pragmatic clinical studies (PCS), feedback from funded PCS researchers, and input from the PCORI 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.
In the context of the Novel Coronavirus
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. PCORI notes 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 the COVID-19 Updates
webpage to stay updated on PCORI’s response to the pandemic.
September 29, 2020.