Team members at Mass General’s Neurological Clinical Research Institute (NCRI) are confident that big data can lead to big results and huge gains in clinical research.

The center, which designs, supports, and manages clinical research in neurological disorders, is developing novel ways to harness and interpret data sets generated from patient information that are so large and complex traditional approaches simply are not feasible. The end goal of the data-specific programs: to better understand rare conditions, better diagnose these disorders, and ultimately find new or better treatments.

The data come from all different types of sources. Take, for example, EEG recordings, which produce continuous streams of electronic information. Then there are vital signs, disease-specific measures, and medical images, not to mention tangible data such as vials of biofluids and DNA samples. Beyond that, patients now record their own so-called patient-reported outcomes and health statistics via mobile apps and websites. Any source on its own may not suffice, but many taken together, could be the key to a cure.
Making Order Out of Chaos
Applying the oft-used business concept of big data to medicine means that information from all these avenues has a purpose beyond an individual’s clinical care at a point in time.

To the NCRI, big data mean the opportunity to learn more about rare diseases that traditionally don’t attract the attention of pharmaceutical and biotech companies. By organizing disease-specific consortia, bringing multiple stakeholders like academic research centers, clinicians, patients, and foundations together, and facilitating clinical research studies, a rare disease may become ready to attract the industry to develop much-needed drugs or improve existing medications.

For a biotech company to take on a drug development, especially for a rare disease, clear biomarkers and outcome measures must be in place. Determining and validating such biomarkers require lots of information: clinical and phenotypical data, DNA, disease natural histories, -omics, and images.

Of course, just having the data is not enough. Compliance to regulations, legal requirements and laws, both national and international, and recommendations from governing bodies in data acquisition, curation and handling without compromising patient privacy is paramount.

“We had to ask how do we merge this information knowing that it all comes from the same person without revealing who this person is,” explains Alex Sherman, director of the NCRI’s Center for Innovation and Biomedical Informatics.

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