May 15, 2016 (Vol. 36, No. 10)

Kate Torchilin Ph.D. CEO Novaseek Research

New Clinical Data Network Technologies Improve Access to Patients

New technology is enabling biopharma researchers to reach groups of patients that traditionally have been hard to reach. Over 80% of all patients in the U.S. are treated in community healthcare settings, so these institutions hold the key to facilitating research with populations that are ethnically, racially, geographically, and socioeconomically diverse. Federal agencies, including the FDA and the NIH, have taken steps to encourage or mandate increased diversity in research and broader patient engagement in community healthcare settings.

On the industry side, R&D organizations are increasingly focused and interested in approaches that result in the right treatment for the right patient at the right time. Key to realizing such outcomes are broader population-based studies that further the understanding of “multi-omic” diversity and how that diversity influences healthcare outcomes. An engaged society with millions of individuals’ biologic information available to researchers will enable faster progress in medical developments.

Today, accessing such information is achievable. The widespread use of electronic medical records (EMRs) combined with improved data analytics can help researchers find and access patients, whether in large metropolitan hospitals, community hospitals, or other healthcare organizations that traditionally had limited research participation. Furthermore, the application of new technologies and methodologies can now automate the necessary collection of both clinical information and biospecimens from the right patient populations either directly or during a visit to a doctor. This approach creates a virtual, sustainable, and more efficient ecosystem on which to base precision medicine research.

The use of electronic medical records combined with improved data analytics can help researchers find and access patients that traditionally had limited research participation. [iStock/RichLegg]

Streamlining Research

As more healthcare data becomes digitized, it creates a foundation to support the development of new tools and platforms to facilitate research. These tools reduce the time and effort involved in collecting clinical data for research purposes and they empower broader patient engagement, making it more plausible for community healthcare organizations to adopt these approaches.

For precision medicine to become clinically relevant, researchers need better access to patients, data, and biospecimens as well as to the technology tools so that they can ask scientifically relevant questions about disease status and progression. However, common challenges in utilizing clinical data for research include: (1) bringing together data from multiple healthcare systems, as well as supporting longitudinal patient follow-up, (2) storing and using the clinical data in compliance with the Health Insurance Portability and Accountability Act (HIPAA), (3) supporting an easy, intuitive way for researchers to access and use the clinical data for their projects (that is, no need for specialized medical or IT knowledge to query and use the data), and (4) affordability, so that it fits within the research budgets.

Currently, what is typically available to researchers are aggregated anonymized historical databases that often have incomplete patient data (for example, procedure codes but not the laboratory test results) and do not allow for prospective following up of the patient. These problems arise both because of the technology solutions that have been used to get such data (that is, downloads of anonymized historical data from electronic records or insurance claims databases) and how the patient consent/HIPAA data-sharing authorization has been set up (that is, patients not giving HIPAA data-sharing authorization and consent to share their clinical data for research and thus only anonymized data can be used). Such data is of limited value for research and does not allow development of a truly patient-centric view for R&D projects that are needed for precision medicine.

Clinical Data Network for Research

The Novaseek Clinical Data Network for Research (CDNR) is one example of a research platform designed to fill these gaps. The CDNR accepts data from multiple hospitals’ EMRs, allowing researchers to query relevant data, such as diagnostic tests, medications, and diagnoses from thousands of consented patients via intuitive user interfaces and to request biospecimens from patients with specific conditions or clinical histories, as well as the ability to collect biospecimens prospectively from same patients.

Genomic profiles also are increasingly included in these records. And with the growth of wearable devices, patients may begin adding that data to their own medical records for an even more comprehensive look at their health and lifestyle. With such detailed data, researchers can more easily stratify patient populations, collect biospecimens for precision medicine discoveries, and conduct a variety of noninterventional studies, such as determining the effects of lifestyle factors on disease.

Overcoming Barriers for Precision Medicine

For precision medicine approaches to affect health outcomes positively, the research should be intergrated with clinical practice. The community hospitals and physician offices that provide care for the majority of people in the U.S. should be a fertile ground both for the research and for the implementation of individualized care for each patient.

Recognizing the importance of this approach, President Barack Obama recently announced The Precision Medicine Initiative (PMI), which relies on widespread participation throughout the entire healthcare system. First funded in 2016, PMI calls for tracking medical and lifestyle data and collecting biospecimens of more than one million people in the United States in an effort to identify the most effective strategies to prevent disease onset and improve patient outcomes. Involving patients not traditionally included in medical research is a key component of that ambitious goal.

Leveraging platforms that allow access to clinical data and EMRs in a streamlined, cost-effective way would enable broad patient participation and would provide the patient diversity and specificity that researchers need, while enabling community healthcare facilities to participate in research without disrupting physician practices. And because patient engagement is so critical for all such programs, providing a convenient way to patients to participate, including right in the community where they live and are accustomed to receiving healthcare, is important.

Ultimately, today’s technological innovations make broader access to patients possible and enable patients, hospitals, technology providers, and researchers to work together toward better healthcare.

Kate Torchilin, Ph.D. ([email protected]), is CEO at Novaseek Research.

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