Our Commitment

Gilead is committed to making information about our clinical research publically available. We believe that transparency advances science and medicine and is in the best interest of the individuals who use our products and providers who prescribe them.

  • We strive to ensure that our research practices are transparent, responsible, and fully compliant with applicable laws and regulations.
  • We have staff dedicated to ensuring the timely registration of clinical trials, communication of research results, and release of clinical trial documents.
  • We collaborate with external medical experts and scientific researchers to advance clinical research and enhance public health.

Gilead provides this information consistent with the need to protect patient privacy, publication rights, and proprietary information.

Details regarding Gilead’s pipeline of investigational medicinal products can be found at http://www.gilead.com/research/pipeline. Additional information regarding specific Gilead clinical trials can be found on publicly accessible registries including www.clinicaltrials.gov (CTgov) and www.clinicaltrialsregister.eu (EU-CTR).

If you have a specific inquiry regarding Gilead’s Clinical Trial Disclosure and Data Transparency commitment or practices, please contact us at GileadClinicalTrials@gilead.com

Clinical Trial Registration 

Gilead registers clinical trials on clinical trial registries such as ClinicalTrials.gov (CTgov) and EudraCT (www.clinicaltrialsregister.eu) (EU-CTR) as required by law and/or regulation, and in accordance with local requirements. 

Gilead ensures that clinical trials are registered prior to publication in peer reviewed journals such as those which are members of the International Committee of Medical Journal Editors (ICMJE). 

Posting of Clinical Trial Results

Gilead discloses summary clinical trial results, regardless of the outcome of the trial, as required by law and/or regulation. This includes Gilead-sponsored clinical trials that have been registered on publicly accessible clinical trial registries.

In the USA, summary results are posted on ClinicalTrials.gov (CTgov) no later than 12 months after the study’s primary completion date. A full definition of primary completion date can be found in the ClinicalTrials.gov study glossary

  • For studies related to products that have not yet been approved or are being investigated for new uses, Gilead posts summary results on ClinicalTrials.gov (CTgov) within 30 days of receiving regulatory approval.
  • In Europe (EU and EEA), summary results are posted on the European Union Clinical Trial Register (EU-CTR) no later than 12 months after the trial Last Patient Last Visit Date (LPLV) for trials with adult participants and no later than six months after the trial LPLV Date for trials with pediatric participants.

Release of Clinical Documents

Gilead releases, either by submitting to Regulatory Authorities or by posting directly to clinical trial registries, clinical documents as required by law and/or regulation. For studies in the USA and Europe, Gilead redacts confidential patient information and Gilead specific sensitive information in order to ensure patient privacy and the protection of proprietary information. Any redaction of information or data is conducted in accordance with applicable law or regulatory guidance.

In the USA, Gilead uploads final Portable Document Format (PDF) versions of the clinical trial protocol and statistical analysis plan (SAP) for required clinical trials to ClinicalTrials.gov (CTgov) at the time summary results are posted. This policy applies to Gilead-sponsored clinical trials with a primary completion date on or after 18 January 2017.

In Europe, Gilead submits to the European Medicines Agency (EMA) clinical trial documents that were used in support of a product's marketing authorization. These documents are posted on the EMA’s Clinical Data Website following approval of the product and are available to the public. This policy applies to trials included in marketing authorization applications (MAAs) submitted to the EMA from 01 January 2015 and applicable Type II Variation submissions from 01 July 2015.

Sharing of Clinical Trial Data 

Gilead is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Gilead shares anonymized Individual Patient Data (IPD) on request or as required by law and/or regulation and for approved requests from independent researchers. Such approvals are at Gilead’s discretion and dependent on the nature of the request, the merit of the research proposed, and the intended use of the data. If Gilead agrees to the release of clinical data for research purposes, the requestor will be required to sign an information/data use agreement in order to ensure protection of patient confidentiality prior to the release of any data. 

If you would like additional information or would like to request access to Gilead clinical trial data for research purposes please contact us at ClinicalDataRequest@gilead.com.