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Communication
Timely access to trial data in the context of a pandemic: the time is now
  1. Rebecca Li1,2,
  2. Julie Wood1,
  3. Amrutha Baskaran1,
  4. Stanley Neumann1,
  5. Elizabeth Graham1,
  6. Marcia Levenstein1,
  7. Ida Sim3
  1. 1Vivli, Cambridge, Massachusetts, USA
  2. 2Center for Bioethics, Harvard Medical School, Boston, Massachusetts, USA
  3. 3Division of General Internal Medicine, University of California San Francisco, San Francisco, California, USA
  1. Correspondence to Dr Rebecca Li; rli{at}vivli.org

Abstract

Objective Clinical trial data sharing has the potential to accelerate scientific progress, answer new lines of scientific inquiry, support reproducibility and prevent redundancy. Vivli, a non-profit organisation, operates a global platform for sharing of individual participant-level trial data and associated documents. Sharing of these data collected from each trial participant enables combining of these data to drive new scientific insights or assess reproducibility—not possible with the aggregate or summary data tables historically made available. We report on our initial experience including key metrics, lessons learned and how we see our role in the data sharing ecosystem. We also describe how Vivli is addressing the needs of the COVID-19 challenge through a new dedicated portal that provides a direct search function for COVID-19 studies, availability for fast-tracked request review and data sharing.

Data summary The Vivli platform was established in 2018 and has partnered with 28 diverse members from industry, academic institutions, government platforms and non-profit foundations. Currently, 5400 trials representing 3.6 million participants are shared on the platform. From July 2018 to September 2020, Vivli received 201 requests. To date, 106 of 201 requests received approval, 5 have been declined, 27 withdrew and 27 are in the revision stage.

Conclusions The pandemic has only magnified the necessity for data sharing. If most data are shared and in a manner that allows interoperability, then we have hope of moving towards a cohesive scientific understanding more quickly not only for COVID-19 but also for all diseases. Conversely, if only isolated pockets of data are shared then society loses the opportunity to close vital gaps in our understanding of this rapidly evolving epidemic. This current challenge serves to highlight the value of data sharing platforms—critical enablers that help researchers build on prior knowledge.

  • information management
  • information technology
  • public health
  • statistics & research methods
  • public health
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Twitter @Mjl22g, @idasim

  • Contributors All authors conceived and gathered data for the manuscript and contributed to the tables and figures. RL summarised the data and wrote the manuscript. JW, AB, SN, EG, ML and IS provided comments on the manuscript and approved the final version of the manuscript for publication.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests Vivli receives funding support from the Arnold Ventures, Doris Duke Charitable Trust, the Helmsley Charitable Trust, pharmaceutical industry and academic institutional data contributors to Vivli.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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