United States: Improving Methods for Conducting Patient-Centered Comparative Clinical Effectiveness Research

Deadline: 4 September 2024

The Patient-Centered Outcomes Research Institute (PCORI) is seeking applications for it’s funding opportunity to fund studies that address high-priority methodological gaps in patient-centered comparative clinical effectiveness research (CER).

The availability of multiple options for prevention, diagnosis, and treatment in health care presents a significant challenge to patients and clinicians trying to make informed care decisions. Deciding between alternative options in health care requires an understanding of how to balance the benefits and risks of each treatment option and an understanding of how each option might apply differently to different patients, given their unique personal characteristics. However, limitations in the design, implementation, and analysis of clinical research may produce biased study results that can have serious consequences for patients

The PCORI Methodology Standards address some of the challenges related to the planning, conduct, and reporting of patient-centered CER, but these standards are not exhaustive. PCORI and its Methodology Committee recognize the need to better understand and advance the appropriate use of these methods for patient-centered CER. PCORI seeks to fund projects that address important methodological gaps and lead to improvements in the strength and quality of evidence generated by patient-centered CER studies.

Priorities

For the 2024 Methods PFA, PCORI has identified the following areas as programmatic priorities that address important methodological gaps and lead to improvements in the strength and quality of evidence generated by CER studies:
- Methods to Improve the Use of Artificial Intelligence (AI) and Machine Learning (ML) in Clinical Research
- Methods to Improve Study Design
- Methods to Support Data Research Networks
- Methods Related to Ethical and Human Subjects Protections Issues in patient-centered CER

Themes

The Topic Themes, clustered into three groups, are as follows:
- Populations
  - Improving outcomes for people with intellectual and developmental disabilities (IDD)
  - Promoting health for older adults
  - Promoting healthy children and youth
- Health Behaviors
  - Addressing substance use
  - Addressing violence and trauma
- Health Conditions
  - Addressing COVID-19
  - Addressing rare diseases
  - Improving cardiovascular health
  - Improving mental and behavioral health
  - Managing pain
  - Preventing maternal morbidity and mortality (MMM)
  - Promoting sleep health

Funding Information

Maximum Project Budget: $750,000
Maximum Research Project Period: 3 Years

Eligibility Criteria

In general, applications for the conduct of research and management of funding may be submitted by appropriate academic research, private sector research, or study-conducting entities. This may include, among others, agencies and instrumentalities of the Federal Government, nonprofit and for-profit research organizations, and colleges and universities.
Per PCORI’s authorizing statute, every applicant must demonstrate capability to comply with the following conditions: abide by the transparency and conflicts of interest requirements that apply to PCORI with respect to the research managed or conducted under contract; comply with the PCORI methodological standards adopted by the Board of Governors; consult, as appropriate, with the expert advisory panels for clinical trials and rare disease; deposit de-identified data from the original research into a PCORI designated repository to facilitate data sharing, as appropriate; have appropriate processes in place to manage data privacy and meet ethical standards for the research; comply with the requirements of PCORI for making the information available to the public; and comply with other terms and conditions determined necessary by PCORI to carry out the research project.

Ineligibility Criteria