After entering the original data, he logged in as the trial sponsor and tried to erase adverse events that had been reported for two patients in their case report forms. Instead of deleting those reports, however, the system appended his changes to the original data, making it clear who had tried to corrupt the forms, when it was done, and what had been changed.
Wong also tried corrupting the data stored from an earlier point in the trial, when patients were assigned to different treatment arms -- drug or placebo -- to make it look as though they had been given a different medication plan. But the blockchain ledger pinpointed exactly what had changed and when.
A prototype system like this reduces risks, but does not completely protect data from tampering. Even within a system enabled with this type of blockchain technology, the authors pointed out, it is still possible that those seeing patients at the point of care could enter wrong or incorrect data at the outset.
But blockchain technology could enable trials to be conducted under challenging conditions, or open doors to data exchanges that are more secure, more efficient, and more transparent for both researchers and the general public.
"A system built upon our prototype could be developed to enable oversight of international clinical trials, for example," Butte said. "And it could be expanded to provide more access to raw data for research scientists, the way we do with ImmPort, or deliver trial results to the public."
Authors: Daniel R. Wong, Sanchita Bhattacharya, and Atul J. Butte, MD, PhD, of the Bakar Computational Health Sciences Institute at UCSF.
Funding: The study was partially supported by the National Institute of Allergy and Infectious Diseases.
About UCSF:
UC San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It includes top-ranked graduate schools of dentistry, medicine, nursing and pharmacy; a graduate division with nationally renowned programs in basic, biomedical, translational and population sciences; and a preeminent biomedical research enterprise. It also includes UCSF Health, which comprises three top-ranked hospitals - UCSF Medical Center and UCSF Benioff Children's Hospitals in San Francisco and Oakland - as well as Langley Porter Psychiatric Hospital and Clinics, UCSF Benioff Children's Physicians and the UCSF Faculty Practice. UCSF Health has affiliations with hospitals and health organizations throughout the Bay Area. UCSF faculty also provide all physician care at the public Zuckerberg San Francisco General Hospital and Trauma Center, and the SF VA Medical Center. The UCSF Fresno Medical Education Program is a major branch of the University of California, San Francisco's School of Medicine.
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