Sponsor Specific Details: ViiV Healthcare

All ViiV sponsored interventional studies which evaluate ViiV medicines that are started in or after November 2017, or that reach their primary completion date after this date.

Other studies where data have been provided to researchers.

Prior to November 2017, ViiV Healthcare listed all interventional phase II-IV clinical studies on www.viiv-clinicaltrialregister.com that study ViiV Healthcare medicines in people living with HIV.

Where feasible, ViiV Healthcare will list studies that do not meet these criteria but add significant information to the understanding of a licensed medicine.

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

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

Prior to November 2017, ViiV Healthcare did not list studies on compounds whose development had been terminated.

For studies that are not listed, ViiV Healthcare will assess the feasibility of data provision as part of the review of enquiries.

Within 6 months of publishing the results of the primary endpoints of the study (Implementation of this policy change began in November 2017). Prior to that time, the medicine must have been approved by regulators (first approval) or terminated from development and the study had been accepted for publication.

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 (or its parent companies) were researching. Further research must therefore study the medicine or disease that was researched in the original studies.

For studies ViiV Healthcare conduct from 2014, patients will be asked to give permission for broader research so other research may be possible with data from these studies.

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

Raw dataset. This is the data collected for each patient in the clinical study.

Analysis-ready dataset. This is the dataset used for ViiV Healthcare's analysis.

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. 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 Clinical Study Register. If the documents needed are not available on the register, then an enquiry can be submitted.

For Interventional studies started in or after November 2017, or studies that reach their primary completion date after this date Clinical Study Reports (with personal information removed) are posted onto the ViiV Healthcare Clinical 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 list studies for patient level data sharing within 6 months of publishing the results of the primary endpoints of the study. Prior to November 2017, studies were listed after authorisation of the medicine (or the decision has been taken to terminate development of the medicine) and acceptance of the study for publication in the scientific literature.

Whether ViiV Healthcare are able to provide the requested data. For example, the majority of non-interventional (or observational) studies use data from third party databases under licence 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.

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.

http://www.ViiV-clinicalstudyregister.com/