DOI: 10.1002/alz.079073 ISSN: 1552-5260

A perspective on data sharing from potentially registrational trials

Kaycee M. Sink, Lesley Narburgh, Nan Hu, Katherine Tucker, Rachelle S. Doody
  • Psychiatry and Mental health
  • Cellular and Molecular Neuroscience
  • Geriatrics and Gerontology
  • Neurology (clinical)
  • Developmental Neuroscience
  • Health Policy
  • Epidemiology


It is well recognized that sharing rich and rigorously collected clinical trial data with researchers who were not conducting the study has the potential to accelerate progress in Alzheimer’s disease.. Such data sharing can contribute to an understanding of pathophysiology, natural history, performance of outcome measures, and the profile of response to treatments, and can help researchers to design better studies and health authorities and payors to evaluate the benefits of therapies. The complexities involved in such data sharing include the need to keep up with evolving patient privacy laws, protecting participant anonymity, ensuring trial integrity, and balancing regulatory and publication requirements. In 2012 Roche/Genentech made a commitment to Banner Alzheimer’s Institute and the NIH to share baseline and longitudinal trial data from the Alzheimer’s Prevention Initiative Autosomal Dominant AD trial, a public‐private partnership. We will describe the mechanisms developed to share data from the API ADAD Trial (baseline data now available; longitudinal clinical, imaging, and biomarker data to follow) including methods employed to protect confidentiality and anonymity of participants, and the process for requesting and accessing baseline data. We will also offer learnings from our experiences in sharing data from other neurodegeneration trials.

The API ADAD trial was funded by NIA grants RF1‐AG041705, R01‐AG055444, Genentech, Roche, philanthropic contributions to Banner Alzheimer’s Foundation. Florbetapir PET was partly supported by Avid and Lilly.

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