PCORI Joins Federal Agencies in Call for Collaboration in Big-Data Clinical Research

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.