PCORI Joins Federal Agencies in Call for Collaboration in Big-Data Clinical Research
- The PCORI Strategic Plan
- Clinical Effectiveness and Decision Science
- Dissemination and Implementation
- Evaluation and Analysis
- Healthcare Delivery and Disparities Research
- PCOR Infrastructure & Innovation
- Our Vision & Mission
- Financial Statements and Reports
- The PCORI Strategic Plan
- Board of Governors
- Methodology Committee
- Authorizing Law
- Evaluating Our Work
- PCORI's Advisory Panels
- Procurement Opportunities
Past Opportunities to Provide Input
- Stakeholder Views on Components of 'Patient-Centered Value' in Health and Health Care (2023)
- PCORI's Proposed Research Agenda (2021-2022)
- Proposed National Priorities for Health (2021)
- Proposed Principles for the Consideration of the Full Range of Outcomes Data in PCORI-Funded Research (2020)
- Proposed New PCORI Methodology Standards (2018)
- Data Access and Data Sharing Policy: Public Comment (2017)
- Proposed New PCORI Methodology Standards (2017)
Comment on the Proposed New and Revised PCORI Methodology Standards (2016)
- 1. Standards for Formulating Research Questions
- 10: Standards for Studies of Diagnostic Tests
- 12. Standards on Research Designs Using Clusters
- 13: General Comments on the Proposed Revisions to the PCORI Methodology Standards
- 2: Standards Associated with Patient-Centeredness
- 3: Standards for Data Integrity and Rigorous Analysis
- 4: Standards for Preventing and Handling Missing Data
- 5: Standards for Heterogeneity of Treatment Effects
- 6: Standards for Data Registries
- 7: Standards for Data Networks as Research-Facilitating Structures
- 8. Standards for Causal Inference Methods
- 9. Standards for Adaptive Trial Designs
- Peer-Review Process Comments (2014)
- Draft Methodology Report Public Comment Period (2012)
- Past Opportunities to Provide Input
PCORI is pleased to join a consortium of top federal and other biomedical research funders in a call, published in the New England Journal of Medicine, for greater collaboration across the healthcare delivery and research communities in sharing data, computational capacity, and infrastructure for the purpose of conducting more effective clinical research.
The goal is to advance a vision and core commitment that PCORI shares with all of these funders: speeding the development of more high-quality evidence to support critical healthcare decisions.
Creating High-Quality Evidence
Making the best choices about health and health care requires access to the best evidence, the consortium notes. Unfortunately, only a limited amount of this kind of information is now available. But rich and varied sources of digital data, such as electronic health records and insurance claims, are becoming widely available. The analytical tools, as well as data use, privacy, and security policies needed to tap into these and other data sources, are also becoming more sophisticated. The concept that this research must engage the patients, clinicians, systems, and insurers that are providing the data is now firmly established.
With this backdrop, we and fellow funders believe the research and healthcare communities have the opportunity to quickly and efficiently generate evidence to improve decision making about health and health care. Many such efforts are now under way, including PCORnet, the National Patient-Centered Clinical Research Network, PCORI’s innovative effort to harness the value of electronic health records, claims data, patient-reported data, and unique patient partnerships to allow us to conduct large-scale, high-quality health research more efficiently, with greater power, and less expensively than ever before.
Laying the Groundwork
In our NEJM article, we and our coauthors note that the consortium plans to engage stakeholders across the healthcare community to pursue this goal—as we at PCORI have done since our inception, in pursuing our patient-centered comparative clinical effectiveness research agenda.
The article lists five core principles for transforming generation of evidence to more effectively support health decisions:
- Organize operational systems that bring together research networks embedded in practice to enable patients, physicians, and all other stakeholders to participate in research that generates high-quality evidence for multiple purposes.
- Establish a robust framework for privacy, confidentiality, and security, endorsed by patients and consumers, to ensure the creation of a trusted learning health system.
- Adopt a common approach to configuring, storing, and reusing digital healthcare data to enable use in care, research, safety surveillance, and public health.
- Develop and test novel methods for reliably and efficiently soliciting and answering research questions.
- Develop approaches that enable research streamlining and process harmonization while maintaining safeguards for patient well-being and study integrity.
Along with these efforts, we and our coauthors also commit to engaging patients and other stakeholders from across the healthcare community as our work progresses—something we at PCORI have emphasized as a central value.
In so doing, we and our fellow funders plan to meet President Obama’s challenge to pursue greater collaboration in data sharing to accelerate scientific discovery. It is an approach that, we believe, will allow our healthcare system to be better able to offer the right therapy for the right patient at the right time, thus improving the quality and effectiveness of patient care, and leading to the goal everyone seeks: better health outcomes for all.
As always, we invite your thoughts on our work and suggestions for how we can better serve the healthcare community.
January 11, 2017, 2:39 PM
Comment by Eva May,
January 10, 2017, 2:35 PM
Comment by PCORI,
Thank you for your comment, Peter.
January 7, 2017, 8:50 AM
Comment by Peter Bibertha…,
The PCORI Project will create substantial data to influence health care all over the world. I am head of a german Trauma and orthopedic surgical department and we developed several scientific instruments which allow a vaild and effective outcome Research on orthopedic patients. By that we were able to check up all of our patients operated the last 10 years with a limited amount of Research funding. Currently, we are building up a national wide fracture Register in Germany. If you are interested in colaboration, please do not hesitate to contact me
December 22, 2016, 5:07 PM
Comment by Loon-Tzian Lo,
It would be great if patient care data from varying healthcare systems could be utilized collaboratively.
December 21, 2016, 2:49 PM
Comment by PCORI,
Hi Mara and Gary, thank you both very much for your comments.
December 20, 2016, 8:19 PM
Comment by Gary Bodenheimer,
Improve patient care in hospitals, improve patient experiences in hospitals, improve health care systems, improve communication with patients, improve community health care, and most of all respect the patient
December 20, 2016, 4:49 PM
Comment by Mara Bird,
I'm writing to express my support for this initiative as I see that it could help to have comparative data across Latino sub-populations including indigenous immigrants that would be helpful to improve the health of all.
Another step in the process is to make sure we can educate patients and students how to access the data.
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Love the initiative, love the core principles, and love President Obama’s challenge to pursue greater collaboration in data sharing to accelerate scientific discovery. Your persistence in strategic messaging and transparent actions will pay out abundantly - and I hope many others will join in to speed improved outcomes and reduce suffering and wasted resources.