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Collecting and Sharing Patient Data: Guiding Principles, Governance, and Sustainability

Collecting and Sharing Patient Data: Guiding Principles, Governance, and Sustainability


Establishing and developing a data collection and management platform can be a central activity for many patient foundations that have a mission to advance biomedical R&D. Throughout the history of The Research Acceleration and Innovation Network (TRAIN), FasterCures has provided resources and insights from the patient organization community to leverage innovations and promising practices from those that have established effective patient data platforms to drive their research initiatives forward. And as registries have grown in their capacity to collect complex, longitudinal, and real-world patient data, corresponding issues related to 1) how the data can be securely and ethically used, managed, and shared and 2) how the data platforms can be sustainably funded over the long term have emerged. To explore these issues, Kristin Schneeman (director at FasterCures, a center of the Milken Institute) moderated a TRAIN webinar featuring Caren Heller (chief scientific officer of the Crohn’s & Colitis Foundation), David Walton (CEO of the T1D Exchange), and Sharon Terry (CEO of Genetic Alliance) to share their organizations’ lessons learned and approaches to tackling those issues.

Heller described the Crohn’s & Colitis Foundation’s platform IBD Plexus, Walton described the T1D Exchange, and Terry provided an overview of Genetic Alliance and Luna DNA’s Promise for Engaging Everyone Responsibly (PEER) platform. IBD Plexus and T1D Exchange are data platforms associated with specific diseases (Crohn’s disease/ulcerative colitis and type 1 diabetes, respectively), while the PEER platform is a resource that can be adopted widely by patient organizations across conditions seeking to establish their own data management platforms.

Guiding Principles for Data Collection and Sharing

Each of the presenters described how they built their data platforms over the years. A foundational theme of trust emerged: Their organizations serve as trusted partners to the patient community and with the academic researcher and industry communities. Building this trust was essential to enabling the robust collection and sharing of patients’ health data and to attracting interest and utilization of those data for academic and industry biomedical R&D. Additional guiding principles across the presenters’ three talks included:

  • starting with a narrow focus (often to characterize the disease) and expanding over time to focus on additional research needs,

  • ensuring the data collection efforts are not overly burdensome on the patient/caregiver community,

  • integrating multiple data sources (including patient-reported outcomes, clinical and electronic health record [EHR] data, biosample-derived data, prescription and insurance claim data, device and real-world data, and available external data sets) for a comprehensive view of the patient experience, and

  • ensuring that data collection is fully representative of those with the disease and inclusive of underrepresented racial and ethnic minority communities.

Data Governance, Privacy, Security, and Conditions of Use

The panelists also shared a range of promising practices and strategies for how they addressed platform governance, data security and privacy, informed consent, and conditions of use of registry data:

  • Governance:

engaging external stakeholders, including research cohorts/communities and patients, as partners to govern platform policy, usage, and access and to help ensure patient and researcher needs are the main drivers of platform activities

implementing certain data use/governance considerations as needed, if partnering with industry researcher or obtaining data from devices via a company-managed app or cloud account used by patients

  • Informed Consent: initiating informed consent at the start of any data collection efforts, ensuring that participation in all research studies/surveys is optional, requesting access to additional patient records (e.g., EHRs, claims, and prescription data) as part of consent, and informing patients that their data may be used for industry and researcher use

  • Privacy and Security: complying with applicable HIPAA rules and data privacy regulations when sharing data and ensuring patient data privacy and security through strategies such as deidentifying patient data prior to sharing it with external researchers, encrypting database records, and limiting internal access to individual patient records

  • Conditions of Use: implementing agreements with specific terms for data use and ensuring that researchers intend to use data for purposes aligned to the submitted project proposal and will not attempt to re-identify patient records

Funding and Sustainability

Both IBD Plexus and the T1D Exchange obtained initial funding to establish their platforms from The Leona M. and Harry B. Helmsley Charitable Trust. Each platform started with a narrow scope, expanded over time, and developed strategies to obtain funding from other sources to grow research and data management capabilities. Heller articulated their approach to sustainability for IBD Plexus by stressing that “the critical point to be sustainable is to be integral to the IBD community." The foundation helped IBD Plexus remain integral by optimizing its capabilities for the present use and ensuring the capabilities and data collection efforts being assembled would lend themselves to anticipated future needs to attract and retain academic and industry users/funding. Walton also shared that “the more value that [one] can be seen as providing to people and organizations across the ecosystem, the better the chances for sustainability.” Another critical factor for sustainability is making a concerted effort to look for vendors and partners that are aligned on the long-term commitment to the patient organization’s mission. Some additional promising strategies speakers cited included:

  • collecting robust data from the patient community to become the go-to source for patient experience and natural history data on a particular disease and/or condition;

  • partnering with external academic and industry researchers to conduct custom surveys, analyses, and research projects and assisting in clinical trial recruitment and planning;

  • integrating the collection of patient preference data, data on comorbid conditions, device data, and real-world data to increase interest from a broader set of researchers and product/device developers; and

  • developing a membership-based model for external researchers to access platforms and utilize aggregated and/or deidentified data.


Schneeman closed the webinar by asking each presenter to reflect on how they ensure representativeness of patients with their respective diseases and inclusion of diverse ethnic and racial communities in their outreach efforts, and each presenter emphasized the importance of partnerships in those efforts. Schneeman then circled back to Heller’s definition of “plexus,” a structure containing a complex, intricate network of parts, issues, and connections that must all work together to achieve success. This concept holds true for all the interrelated stakeholders that contribute to building and sustaining platforms for collecting and sharing patient data to advance biomedical R&D and ultimately achieve success through new therapies that improve patients’ outcomes and quality of life.

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