The OS PCORTF Leadership Council has endorsed a strategic framework to guide OS PCORTF investments. This framework includes the following component types: 1) Standards; 2) Services; 3) Policies; 4) Governance Structures; and 5) Federal Data. These component types, which help build research data capacity, are described below.
Standards are nationally accepted specifications that have been widely approved and adopted as a result of market forces, community consensus or regulatory requirements. These include, for example, specifications for capturing, storing, representing, linking, and exchanging data in a secure manner so that accurate information is conveyed to the recipient of the data.
Services refer to resources that researchers can use to capture, store, link, analyze, or exchange data or evidence. Services can be provided through a distributed model provided off-site (such as through the internet), over a network or through a cloud-based model. Such services will enable researchers to perform critical tasks that they may not have the capacity, expertise, or resources to perform on their own.
Policies are federal rules or guidelines that need to be established in order to ensure, for example, that:
- Identity checking and security and privacy rules are followed;
- Patient data are protected; and
- Other established standards and services are followed.
For example, national policies could be established for obtaining consent from patients prior to any patient-generated, mobile-device data being released for PCOR.
Governance structures are used to develop and apply the standards and policies required for an interoperable national data research network. While individual research networks will determine the form of governance structure that works best for them, broader governance to enable a national research data infrastructure is also needed. For example, the above-mentioned patient and patient data protection policies may necessitate a need for a third-party governing body, which contains patient advocates, to develop requirements for standards and policies regarding patient-generated data collected via a mobile device.
Federal data sources are also PCOR infrastructure components.Federal data that are useful for PCOR include: clinical data in electronic health record systems maintained by the Indian Health Service and the Veteran’s Administration; current and planned federal quality reporting datasets (e.g., Physician Quality Reporting System, Hospital Inpatient Quality Reporting, Hospice Quality Reporting); disease registries (e.g., the United States Renal Data System), vital statistics (e.g., birth and death data); surveillance data collected by the Centers for Disease Control and Prevention (CDC) and the FDA; claims data maintained by CMS; and bio specimens and bio repository data maintained by the National Institutes of Health. HHS aims to identify investments that will leverage Federal data sources that can be most useful for PCOR by making them more usable and accessible within the national research network. Early examples of a new way of accessing federal data resources include both the CDC’s Research Data Center (RDC) and CMS’s Virtual Research Data Center (VRDC). These data sources allow researchers to access and analyze data stored on CDC and CMS’s servers, rather than physically receiving a copy of the data on portable media. This allows researchers to access federal data more quickly and cost effectively, while providing for greater security and protections.
In addition to the strategic framework components articulated above, the OS PCORTF Leadership Council clarified that investments in these components are to address the core research functions of collecting, linking and analyzing data with a specific focus on enabling the following five priority functionalities:
Collection of Participant-Provided Information:
Participants, including those in safety net organizations, will be able to participate more fully in clinical research by directly providing information (i.e., data points provided by the participant such as Patient Reported Outcomes (PROs)).
Standardized Collection of Standardized Clinical and Claims Data:
Researchers will be able to use standardized case report forms (eCRFs) and participant assessment tools based on research-grade common data elements that are standard across EHR systems and research networks, thereby facilitating linkage and aggregation of data across data sources.
Use of Clinical Data for Current Research:
Researchers will be able to utilize routinely collected clinical data for current implementation of clinical studies (observational and interventional) including data relevant to assessing safety, efficacy and adherence, as well as genetic data and PROs.
Information Capture across the Continuum of Care:
Researchers will be able to follow an individual across care pathways and settings as well as over time, and can more accurately capture the range of variables influencing health outcomes.
Just-in-Time Linking/ Use of Clinical and Other Data for Research:
Researchers will be able to longitudinally follow participants enrolled in clinical trials, and capture and link clinical and other types of data (e.g., claims) required for research regardless of where the participant goes.