Ischaemic Heart Disease
Diabetes & Metabolic
The Virtual International Cardiovascular and Cognitive Trials Archive (VICCTA), is a bespoke collaborative venture that brings existing anonymised datasets from a series of completed trials and registries in the related cardiovascular topics of diabetes, ischaemic heart disease, heart failure, atrial fibrillation, thrombo-embolism and cognition, for secondary scrutiny to benefit the public and inform future clinical research.
Many of these data sets, derived from commercially sponsored studies, would not normally be made available for academic research. VICCTA coordinates access to this data and facilitates novel exploratory analyses (e.g. epidemiology, proof-of-concept, endpoint optimization and pilot studies) on large samples. VICCTA is the extension of its successful sister collaboration, The Virtual International Stroke Trials Archive.
What is in it for established investigators?
While each contributing investigator has exceptional credibility and already has access to a large dataset, analyses from combined datasets benefit from enhanced statistical power, improved generalisability and greater validity.
Because publications are authored including the byline “on behalf of the VICCTA Collaborators”, steering committee members are specifically acknowledged. Medline credits the listed steering committee for the full range of publications that arise.
Members of the VICCTA steering committee can apply to use data from VICCTA. They may also contribute as co-authors to others’ analyses when they have a major research interest or may delegate their rights to a suitably qualified collaborator.
VICCTA does not support re-analysis of specific trials or use of trial datasets for meta-analysis of treatment effects originally studied by the trial. For example, if a trial examined the effects of aspirin, VICCTA would not use that trial’s data in any analysis that concerned effects of aspirin. Data contributors are each members of the steering committee and therefore have influence over the approval of projects.
Thus, VICCTA collaborators will find that they are not relinquishing their rights but instead gaining new opportunities.
What is in it for industry?
VICCTA is an elegant solution.
Commercial sponsors own the intellectual property residing in trial data collected for a particular purpose. The community, on the other hand, now expects that these data should be made publically available if additional health improvement can be gained without compromising that company’s rights. This raises ethical, scientific, legal and commercial challenges for large companies. Hence, VICCTA is an elegant solution, as it is an independent 3rd party platform that analyses and disseminates the data that would be mutually beneficial to the public and commercial sponsors, without compromising any patent or commercially viable aspects. Where necessary, datasets restricted to control groups can be donated.
Guaranteed protection against re-anaylsis of data.
Most companies struggle to resource repeated requests for data or for analyses of data held in-house. They also struggle to operate an approvals system for use of the data much beyond the first year or two after the completion of a trial. VICCTA takes over these responsibilities and guarantees protection as there is no risk of re-analysis of any data used for a regulatory submission, publication or patent application. This is crucial to the success of VICCTA. Its sister collaboration, VISTA, was successful in obtaining data from large pharmaceutical companies including Glaxo-Smith-Kline, Pfizer, AstraZeneca, Boehringer-Ingelheim, Janssen and Bayer.
Data access, extraction and analyses- at low cost
VICCTA also offers commercial sponsors and its investigators access to their own contributed data for the purposes of a subgroup analysis, at no extra cost and hassle-free, subject to approval from the original trial’s steering committee. VICCTA should be able to sustain this access for many years. Data are anonymised with regards to trial source, patient identity and are only released with masking of treatment allocation.
Representation on VICCTA
Sponsors of trials held within VICCTA may nominate an appropriate academic lead (often the chairperson of their trial steering committee) to represent their trial on the VICCTA steering committee. The sponsor may also nominate a company representative to the industry committee or statistical committee.
What does Glasgow contribute and gain?
Data management and administration
The University of Glasgow hosts VISTA and VICCTA – holding and managing securely data and administering the collaborations’ funds – without charging overheads on VICCTA income.
The University benefits indirectly from being associated with high quality research output, from maintaining links with leading clinical researchers and from helping in the development of future researchers.
How can this assist fellows in building their research career?
Embarking on a clinical research programme often involves a long period of data collection and considerable delay in gaining experience with data analysis or publication. VICCTA provides extensive validated data to enable quality research to be completed in minimal time.
Peer review opportunity
Proposals are reviewed by the VICCTA steering committee before approval, and manuscripts are also reviewed before submission. This unparalleled opportunity strengthens the research and enhances the potential impact of the research work.
Input from senior experts – co-authors in publications
Some senior experts from VICCTA may choose to join as co-authors, and the opportunity to publish alongside recognised experts can enhance the research fellow’s CV.
The personal links that are built through VICCTA collaborations may facilitate exchange visits or experience in other countries that are invaluable in planning a career path.
What is in it for the field?
Taking VISTA as an example, it has provided over 100 peer-reviewed publications include some that have influenced
- Research trial design; example: choice of selection criteria and outcome measures in stroke trials
- Clinical treatment guidelines; example: use of thrombolysis in very elderly stroke patients
- Regulatory submissions; example: papers on use of thrombolysis in patients with existing cautions and contraindications for intravenous alteplase in acute stroke
VICCTA may have significant contributions to the fields into which it extends.
How is it funded?
VICCTA is currently subsidised by the University of Glasgow and will run as a full not-for-profit collaboration in the future. It will derive sufficient income to be self-sustaining from subscriptions from the users of the data and from small grants to support specific projects. There is no charge for data donors to access their own contributed data. For other users and for investigators seeking new data, there is a limited project subscription that covers membership of VICCTA during a project plus the actual cost of extracting relevant data from the archive. The limited income from these charges will be used to maintain and expanding the archive. Overheads of VICCTA include provision of administrative and website maintenance.
What assistance can VICCTA provide for projects?
- Expert review from steering committee on proposals and manuscripts
- Management and coordination of permissions and feedback
- Assistance with data selection and extraction
- Feasibility check on proposed research
- In-depth knowledge of original trials
- Opportunity to plan and undertake analysis in Glasgow or work remotely
How are data stored?
The data are stored securely for VICCTA at the Robertson Centre for Biostatistics, University of Glasgow, United Kingdom. The Robertson Centre can also provide excellent professional statistical support.