Transforming Research Beyond 2010 – The New Role for the Patient in Data Sharing and Research


As the 20th century came to a close, the first human genome sequence was being finalized. This was hailed as a landmark achievement in biology – a molecular moon landing. And much of its success was owed to a new approach to doing large-scale science. Called the “Bermuda Principles,” researchers switched from research silos and data hoarding to freely available and immediate publication of basic research across the scientific community. Perhaps we were a bit optimistic about how quickly we could translate knowledge from the human genome project into actual cures, but the project demonstrated the overwhelming value of data sharing and access.

This transformation for open access to research data is still occurring and is gaining momentum within the patient and advocacy communities.  Patient knowledge in this area is evidenced by the Congressional passage of the Genetic Information Non-Discrimination Act in 2008 and the recent introduction of the Federal Research Public Access Act. Both patient communities and policymakers are realizing the value of molecular research and understand that the value multiplies when shared among the medical research community, provided patient privacy and security protections are in place.

In the upcoming years, the role of the patient in research will continue to expand and be critical to realizing the promise of personalized medicine.  The Obama Administration has set a goal to have an electronic medical record for every American by 2014.  The HITECH Act, part of the Recovery Act, which will help pay for adoption of electronic medical records, also ensures that the patient has control of his or her medical data and where the data go. This 2014 timeframe coalesces nicely with our expectation to have low-cost individual genome sequencing, commonly referred to as the thousand dollar genome, in the same time frame– an achievement that would allow every patient to have their genome annotated as a part of their personal electronic health record.

With the convergence of electronic technologies and molecular profiles, patients will begin to drive the transformation of the research environment and break down the walls of research silos. Patients, not scientists, will begin to control who has access to this medical information and how they can use it. Through a more patient-centered healthcare model, patients will play active roles in research by allowing their anonymized health information to populate knowledge environments for researchers. This will create a real-time medical effectiveness data environment and catapult a learning healthcare system. But the information will flow both ways. Through this information exchange, medical researchers will be able to design targeted clinical trials and recruit patients to these trials by searching for specific molecular genotypes. Such information will then flow back to the patient and his or her doctor, outlining opportunities to participate in these trials.

This new world of research will certainly raise policy issues that will need to be addressed, such as patient control, drug approval, and reimbursement for targeted therapeutics.  But there will also be issues in the private sector regarding business models for personalized medicine and issues within the academic setting regarding publication, access to data, and career advancement in a world of real-time data dissemination.  There will also be voices who will oppose this new approach to science, but momentum is gaining and transformation is occurring.  The leaders in the field will be those that recognize and plan for the transformation, understanding that the patient is not a bystander in research, but an active participant.

By Adam Clark, Director of Research and Policy, LIVESTRONG

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