Since Gilead’s inception, employees have worked together to contribute to our mission of advancing patient care by developing groundbreaking therapeutics to treat life-threatening diseases. Fundamental to this mission is Gilead’s adherence to the highest legal and ethical standards of business conduct. As a company driven by science and dedicated to improving patient care and quality of life, Gilead is committed to such standards, as adherence to these protects patient safety, the company, its employees and business customers.
It is the responsibility of every Gilead employee to be knowledgeable about, and comply with, Gilead’s business conduct policies. The company believes working together to move its business forward in the spirit of these policies will continue to enhance the reputation of Gilead Sciences.
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. 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.
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 are publicly listed on Clinicaltrials.gov or EU-CTR. For studies of newly approved compounds or indication the IPD will be available for request 6 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 a 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 DataRequest@gilead.com.
- 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:
- Not attempt to identify the clinical trial subjects.
- Publish the results of the analysis in a scientific journal within one year of analysis completion, or for failed publications, ensure that any analyses performed and associated outcomes are disclosed on an open access journal or publishing platform.
- Provide Gilead with a copy of any proposed public disclosure of the results and comply with Gilead’s request to remove confidential information from the proposed disclosures.
- Provide Gilead a non-exclusive, free of charge license to any invention created arising from the research.
- Indemnify Gilead from third party claims resulting from your conduct of the research with Gilead’s data.