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PRO-ACTive sharing of clinical data

Nature Biotechnology volume 40, pages 999–1000 (2022)Cite this article

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To the Editor — The open sharing of clinical data for research poses challenges not only in resolving consent, privacy and intellectual property issues associated with trial results1,2, but also in subsequently facilitating access to and utilization of the data. Controlled-access systems can place onerous restrictions on industry-based researchers, require arduous application processes and involve long review or authorization times for users. Indeed, analyses of major efforts, such as ClinicalStudyDataRequest.com (CSDR)3,4 and the UK Health Research Authority’s (HRA) Assessment Review Portal (HARP) database5, suggest that fewer than 50% of the available trial datasets in these resources have been accessed and analyzed by researchers after launch. Here, we outline several strategies that ensured that researcher-engagement with an open-access ALS clinical trial data resource reached its full potential. We hope that our insights will be instructive for others seeking to galvanize open clinical data sharing efforts within the broader research community.

Prize4Life, a non-profit organization focused on accelerating treatments and a cure for ALS, created the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database (https://ncri1.partners.org/ProACT/Document/DisplayLatest/9) in collaboration with Massachusetts General Hospital’s Neurological Clinical Research Institute and with funding from the ALS Therapy Alliance. PRO-ACT was publicly launched in 2012 (with further data incorporated in 2015), including demographics, family history, medical history (including use of frontline treatment riluzole), vital capacity, adverse events and other data types from both the placebo and active arms of over 20 clinical trials6,7. The database currently holds >10,000 fully deidentified ALS patient records from 23 phase 2 and 3 clinical trials, representing the largest aggregation of publicly available ALS clinical data.

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Authors and Affiliations

  1. Takeda Pharmaceuticals, Cambridge, MA, USA

    Neta Zach

  2. Accelerating NeuroVentures, LLC, Needham, MA, USA

    Melanie L. Leitner

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  1. Neta Zach
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  2. Melanie L. Leitner
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Correspondence to Neta Zach.

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Competing interests

N.Z. is an employee of Takeda Pharmaceuticals.

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Zach, N., Leitner, M.L. PRO-ACTive sharing of clinical data. Nat Biotechnol 40, 999–1000 (2022). https://doi.org/10.1038/s41587-022-01395-y

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