Sponsor Specific Details: ViiV Healthcare

ViiV Healthcare-sponsored interventional clinical trials conducted with products which: (i) are approved by both the US and EU Health Authorities; or (ii) are approved by either the US or EU Health Authorities when regulatory submissions are not planned in both regions; or (iii) have had development terminated across all indications.

An Enquiry Form can be submitted to confirm the availability of a specific study.

Clinical studies where data labels and/or supporting documents are not in English.

Clinical studies of rare diseases. This is because anonymisation of these data is more difficult to achieve. For these studies ViiV Healthcare will assess the feasibility of anonymisation as part of the review of enquiries.

Clinical studies where there are substantial practical/technical constraints to providing anonymised data. Examples include where data are not available in electronic format or data are images (e.g., X-Ray/MRI scan) or genetic/genomic data.

Prematurely terminated trials that have insufficient enrolment/ exposure to warrant analysis may not be listed.

Within 6 months of:

• Publishing the results of the primary endpoints, key secondary endpoints
• Study product approval in the indication studied (in both US and EU, unless submission is planned for only one of the two regions in which case following approval in either US or EU as applicable, or if submission is not planned for either region first approval in any territory); or asset terminated across all indications.

When patients agreed to take part in ViiV Healthcare clinical studies they gave permission (through informed consent) to use their data to study the medicine or disease ViiV Healthcare were researching. Further research must therefore study the medicine or disease that was researched in the original studies.

Research teams must be appropriately qualified and should include a biostatistician to perform analyses.

ViiV Healthcare will provide access to the relevant data subset within a secure data access system. Interim data from clinical trials will generally not be shared by default, although efforts will be made to share such data in long-term, event-driven trials (such as oncology).

Data will not be provided to requesters where there is a potential conflict of interest, data is to be used for a commercial purpose or there is an actual or potential competitive risk.

Data will not be provided to the requesters to construct an AI-ML model that will serve as the foundation for a commercial product or where the codes, scripts, parameters, final model, resulting software are not made accessible to the wider community via an open-source platform like GitHub, regardless of publication.

Researchers are required to sign a Data Sharing Agreement (DSA). ViiV Healthcare does not anticipate negotiation of the DSA provisions and the researchers are recommended to include an early review of the data sharing provisions included in the DSA template.

This template includes the requirement that as a matter of course ViiV Healthcare receives a non-exclusive royalty-free licence (with the right to sub-licence third parties which ViiV Healthcare collaborates with or engages to perform work on its behalf, as well as ViiV Healthcare's affiliates), to any IP which arises as a result of the use of ViiV Healthcare's data.

In addition, the DSA will include requirements to:

• publish the results of the analysis in a scientific journal or pre-print option (e.g., arXiv); and
• open-source release of any software or models (including the model parameters) developed in the research.

Where available, the following anonymised patient level data and information is provided for each clinical study

Raw dataset. This is the dataset collected for each patient in the clinical study. Patient images from studies are not shared.

Analysis-ready dataset. This is the dataset used for ViiV Healthcare's analysis and will be provided for studies that completed in or after 2007.

Protocol with any amendments. This describes the objectives, design, methodology, statistical considerations, and organisation of a clinical study.

Annotated case report form. This is a blank case report form with descriptions of the data collected and how they are described in the dataset.

Reporting and analysis plan. This describes methods of analysis, procedures for data handling and data displays (figures and tables) ViiV Healthcare used for the study.

Dataset specifications. This is the meta-data which describes the datasets e.g., variable labels, variable descriptions, code lists, formats.

Clinical study report (provided after first approval or termination of the medicine). This is the report of efficacy and safety data from the study. It forms the basis of submissions to regulatory authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Appendices which include patient level data are not included as these data are provided in the datasets ViiV Healthcare provide. To protect research participants' privacy and confidentiality, case narratives are not routinely included. They may be provided where they are needed for a specific research proposal, provided research participants' privacy can be protected.

Researchers can enquire about the availability of data from ViiV Healthcare clinical studies that are not listed on the site before they submit a research proposal.

Researchers can access clinical study documents on the ViiV Healthcare Study Register. If the documents needed are not available on the register, then an enquiry can be submitted.

Clinical Study Reports Synopsis (with personal information removed) are posted on the ViiV Healthcare Study Register after the medicine studied has been approved by regulators (first approval) or terminated from development (all indications).

Whether the studies have been published. It is ViiV Healthcare policy to provide access to patient level data within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.

Whether ViiV Healthcare are able to provide the requested data. For example, studies that use data from third party databases under license agreements which prevent ViiV Healthcare from providing access to the data. Researchers can access data directly from these third-party databases under similar agreements.

Whether ViiV Healthcare have the legal authority to provide the data. For example, ViiV Healthcare may not have the legal authority because the medicine has been out-licensed to another company.

Whether ViiV Healthcare consider it feasible to anonymise the data without compromising the privacy and confidentiality of research participants. For example, anonymisation of data from studies of rare diseases is more difficult to achieve or when there is a reasonable likelihood that individual patients could be re-identified. Such requests will be reviewed on a case-by-case basis.

Whether ViiV Healthcare consider that there are any practical constraints to providing access to the data. For example, there may be issues related to the size of databases from genetic studies.

The resources (costs) for ViiV Healthcare to retrieve data and documents from repositories and archives, anonymise data, and redact personally identifiable information from relevant documents. In some cases, particularly for older studies, the costs could be considerable and ViiV Healthcare may turn down requests on this basis.

Data de-identification will be performed using rule-based approach in accordance with the Safe Harbor method under HIPPA, industry's best standards from PhUSE, TransCelerate, and regulatory guidance from EMA and Health Canada. This is to safeguard the privacy of participants in studies conducted by ViiV in line with the International Conference on Harmonization and Good Clinical Practice (ICH/GCP). The overall aim is for a pragmatic balance, ensuring an acceptably low risk of patient re-identification whilst retaining data utility.

The following data protection procedures for personally identifiable information are performed by ViiV prior to data sharing:

• Patient identifiers (subject number): Replaced by a recoded value, consistently across all datasets to keep the patient-record relationship.
• Further unique identifiers: Removal of identifiers such as kit numbers and devices.
• Site ID: Replaced by a recoded value.
• Date of birth: Removed.
• Age: Aggregation of Age >89 (Age >89 set to blank for all participants, and create the age category)
• Country: Retained.
• Dates/Times related to study subject: Date offset to +365 to -365 days. Same offset value for all dates of a patient, however different offset per patient. Time remains unchanged.
• Comments, free text, variables containing personally identifiable information (PII), e.g. names, initials: Removed.
• Verbatim term of adverse events, medical history and concomitant medication: Verbatim term will be removed if corresponding dictionary terms are available. If Verbatim term has not been coded, then retain term, review all record for PI.

The basic datasets researchers will access may differ from those submitted to regulator(s) or used in publication(s) due to the de-identification process, potentially preventing researchers from fully replicating the results of ViiV's analyses.

ViiV Healthcare Study Register