Gilead registers clinical trials on clinical trial registries such as ClinicalTrials.gov (CTgov) and European Union Clinical Trials Information System (EU CTIS) 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 Trials Information System (EU CTIS) 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.

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, the EU Clinical Trials Register (EU CTR), or European Union Clinical Trials Information System (EU CTIS). 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

Professor of Clinical Medicine at the George Washington

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

Professor of Epidemiology & Biostatistics UCSF

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:

Gilead understands 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.

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 our vision of creating a healthier world for all people.