Gilead is committed to making information about our clinical research publicly available. We believe transparency advances science and medicine and is in the best interest of the individuals who use our products and investigational therapies, as well as the healthcare 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).
While we make every effort to provide information about Gilead's clinical trials, we recognize that some trials may not appear on our website when there are legitimate reasons to exclude them. Examples include when there exists an agreement with a third party preventing Gilead from disclosing information about the trial; when necessary to comply with medical journal requirements; or due to considerations regarding patent application filings.
If you have a specific inquiry regarding Gilead's Clinical Trial Disclosure and Data Transparency commitment or practices, please contact us at [email protected]
Clinical Trial Registration
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.
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 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.
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.
Commitment to PhRMA/EFPIA
Gilead is a member of the Pharmaceutical Research and Manufacturers of America (PhRMA) & the European Federation of Pharmaceutical Industries and Associations (efpia) and prioritizes 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. All requests in scope of our policy will be reviewed by a Data Sharing Review Panel. In accordance with the PhRMA/EFPIA Principles for Responsible Clinical Trial Data Sharing , the panel will consist of both internal Gilead employees as well as the following 2 external reviewers:
Dr. John H. Powers
Dr. John H. Powers is a physician on faculty as a Professor of Clinical Medicine at the George Washington University of Medicine with a focus on infectious disease.
Dr. Powers has been an investigator on over 60 clinical trials and has particular expertise in the design, conduct and analysis of clinical trials.
Dr. Dave Glidden
Dr. Dave Glidden is Professor of Epidemiology & Biostatistics at UCSF with a focus on prevention and treatment of HIV infection.
He has been involved in studies of HIV prevention (specifically, Truvada for PrEP) for over 12 years and has worked tirelessly in the global scale-up of PrEP, innovative designs/statistical analyses of new PrEP agents, and pharmacologic markers of PrEP exposure.
If the review panel 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 protected]
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.
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 by clicking here.
Sharing Results with Study Participants
Gilead understands the important role that our study participants play in our clinical trials. Plain Language Summaries are currently available for the following studies:
- Phase 3 interventional studies with last patient last visit (LPLV) date after 01 January 2020
- Phase 1 and 4 interventional studies conducted in Spain with LPLV date after 01 January 2020
- All studies submitted to the Clinical Trial Information System (CTIS) as required
- The PLS will be translated into every language where the study was conducted
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.
Gilead and Kite understand that quality provides our patients with confidence in the safety and effectiveness of our life-saving medicines. Quality plays an integral role in the foundation of our culture and upholds our work in research, development, manufacturing, and in the delivery of our innovative therapeutics.
Quality is Our Pledge
Our quality pledge to patients and their families is both personal and embedded throughout our organization. We focus on what matters most to them in what we do and how we do it. At Gilead:
- We are committed to bringing safe, effective medicines to our patients.
- We protect the health and safety of our patients by relying on scientific knowledge and data to identify, manage, and control risks.
- We comply with regulatory requirements to ensure the quality and safety of our products from inception to delivery.
- We scrutinize our data for accuracy, constancy, and reliability to ensure its integrity.
- We uphold excellence of our quality systems and processes and drive for continuous improvement.
We believe that quality not only builds patient trust, but is imperative to Gilead’s vision of creating a healthier world for all people.
|Year request received*
|Number of total requests received
|Out of scope of Gilead's Data Sharing Policy
|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
|No Response Received
*Includes metrics for requests received after the Gilead Data Sharing Platform implementation date of 19 October 2018
|Three-Month FVC Change: A Trial Endpoint for IPF Based on Individual Participant Data Meta-Analysis
|Dr. Fasihul A. Khan
|University of Notti