Clinical Trials Transparency & Data Sharing Policy
Explore Clinical Trials Results
To view Gilead’s completed clinical trials, use the menus below to select a therapeutic area, product or phase and find all available clinical study report (CSR) synopses and results.
Gilead is committed to making information about our clinical research publicly 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.
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
Our Clinical Trials Process
Gilead registers clinical trials on clinical trial registries such as ClinicalTrials.gov (CTgov) and www.clinicaltrialsregister.eu (EU-CTR) as required by law and/or regulation, and in accordance with local requirements.
Gilead ensures that applicable clinical trials are registered prior to the first patient being consented for the study. Registration prior to first patient consent is aligned with the International Committee of Medical Journal Editors (ICMJE) guidelines.
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 for all Gilead-sponsored studies related to an approved product. A full definition of primary completion date can be found in the ClinicalTrials.gov study glossary.
- For studies with a primary completion date prior to January 18, 2017 and 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. For studies with a primary completion date after January 18, 2017 and related to products that have not yet been approved or are being investigated for new uses, Gilead posts summary results within 12 months of primary completion date regardless of approval status.
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 for trials with pediatric participants regardless of approval status.
In countries outside the US and the EU, Gilead adheres to all mandatory results posting requirements in accordance with the country-specific guidelines for that region.
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. 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 February 2019, Gilead joined the Pharmaceutical Research and Manufacturers of America (PhRMA) and since then has been working to enhance transparency initiatives to align with the PhRMA Principles for Responsible Clinical Trial Data Sharing.
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) upon request or as required by law and/or regulation.
Qualified external researchers may request IPD for studies of Gilead compounds approved in the US and the EU with a marketing authorization date on or after January 1, 2014 and publicly listed on ClinicalTrials.gov or EU-CTR. For studies of newly approved compounds or indications the IPD will be available for request six months after FDA and EMA approval. Such requests are at Gilead's discretion and dependent on the nature of the request, the merit of the research proposed, availability of the data 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 a data sharing agreement (DSA) in order to ensure protection of patient confidentiality prior to the release of any data.
Upon execution of the DSA, Gilead will provide access to patient-level clinical trial analysis datasets in a secured analysis environment. Gilead will also make available the CSR synopsis, protocol and statistical analysis plan (SAP).
If you would like additional information or would like to request access to Gilead clinical trial data for research purposes, please contact us at email@example.com
“Gilead is committed to sharing clinical trial data in the interest of advancing public health.”
By submitting your research proposal, you agree to the following:
- All materials submitted to Gilead must be non-confidential and should not contain any markings indicating confidentiality. You agree that Gilead will not treat the information as confidential or proprietary.
- You have provided notice to and obtained all necessary consents from all relevant data subjects prior to submitting their personal information to Gilead.
- If your request is approved, in order to obtain access to Gilead’s data, you will be required to sign a non-negotiable Data Sharing Agreement that requires you to:
Clinical Study Report Synopses
Gilead will post the CSR synopses of completed studies of Gilead compounds approved in the US and the EU with a marketing authorization date on or after January 1, 2014 and publicly listed on Clinicaltrials.gov or EU-CTR within 18 months after study completion. Prior to posting, Gilead will redact confidential patient information and Gilead-specific sensitive information in order to ensure patient privacy and the protection of proprietary information. Available CSRs can be found using the Clinical Trial Results filter at the top of this page.
Sharing Results with Study Participants
Gilead understands the important role that our study participants play in our clinical trials and is working on adopting a mechanism to provide summaries of results of completed studies to study participants in a format that is easily understood.
Certifying Procedures for Sharing Clinical Trial Information
Gilead certifies that we have established policies and procedures to implement the PhRMA Principles for Responsible Clinical Trial Data Sharing.
Publishing Clinical Trial Results
Gilead will submit results from all Phase 3 clinical trials and any clinical trial results of significant medical importance for publication, including results from studies of discontinued development programs.
|Year request received*||2019||2020|
|Number of total requests received||1||8|
|Out of scope of Gilead’s Data Sharing Policy||1||5|
|Gilead internal review panel approved
Status: Data sharing agreement signed & data anonymized
Status: Data sharing agreement in process
|Gilead internal review panel denied
Reason for denial: Did not fully align with Data Sharing Policy
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