Data transparency and sharing

We publish our clinical trials and their results. We share our data

A clinical trial tests a potential drug, medical device, activity, or procedure in people. At Galapagos, we commit to register Galapagos-sponsored Phase 1, Phase 2, Phase 3, and Phase 4 clinical trials conducted in any geographical territory that started as of 1 January 2021. We further commit to make a summary of the results of these Galapagos-sponsored Phase 2 to 4 clinical trials publicly available within 6 months of completion for pediatric clinical trials and 12 months for adult clinical trials. The clinical trials and summary results will be registered on our clinical trial finder, on www.clinicaltrials.gov and/or in the EU Clinical Trials Register. We publish results of clinical trials as of Phase 2 in peer-reviewed scientific journals in a timely manner.

We release, either by submitting to regulatory authorities or by posting directly to clinical trial registries, actual clinical trial documents, such as protocols and clinical trial reports, as required by law and/or regulation.

We commit to ensure full compliance with all applicable laws and regulatory guidance and provide specific attention to the protection of personal data at a clinical trial participant level.

We commit to share clinical trial data that support an approved indication in the EU or the US for which Galapagos is the Marketing Authorization/New Drug Application Holder with independent medical experts and scientific researchers in the interest of advancing public health. For clinical trials of newly approved compounds or indications, anonymized patient data can be requested at the earliest 6 months after EMA and FDA approval. The clinical trial last patient last visit must have occurred at least 18 months prior to the request.

As such, we provide support for researchers to submit a request to access anonymized patient data via https://vivli.org/.