Study sponsor: ViiV Healthcare
||Globally sponsored interventional phase II-IV clinical studies listed on www.viiv-clinicaltrialregister.com
that study ViiV Healthcare medicines in people living with HIV.
Other studies where data have been provided to researchers.
Where feasible, ViiV Healthcare will list studies that do not meet these criteria
but add significant information to the understanding of a licensed medicine.
||The current list
does not include compounds whose development has been terminated.
For studies that are not listed, ViiV Healthcare will assess the feasibility of
data provision as part of the review of enquiries.
|When studies are listed
||After the medicine studied has been approved by regulators (first approval) or terminated
from development and the study has been accepted for publication.
|Additional conditions for data access
||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
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.
|Datasets and documents provided
||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
Analysis-ready dataset. This is the dataset used for ViiV Healthcare’s
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.
|Access to study documents without patient-level data
Researchers can enquire about access to clinical study documents by completing the
online enquiry form.
|Review criteria for enquiries
||Whether the studies have been published or accepted for publication and whether
they researched authorised medicines (for approved uses). It is ViiV Healthcare
policy to provide access to patient level data 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.
|Clinical study register