Boehringer Ingelheim, GSK, Sanofi and ViiV Healthcare have agreed to make anonymised patient-level data from clinical trials available to researchers on request through a new online portal launched by enterprise-software specialist ideaPoint.
Access to the data at www.clinicalstudydatarequest.com will be subject to assessment and approval by an independent review panel, initially comprising three academics and a board member of the UK’s Clinical Research Collaboration.
It will also depend on the study sponsors having listed the relevant trials on the site. Researchers may inquire directly with some sponsors about the availability of data not listed through the secure portal.
The companies involved have their own listing criteria, which may exclude, for example, Phase I data; studies subject to licensing or practical constraints (e.g., large genomic datasets, informed-consent restrictions); some historical data; or studies in small populations/rare diseases where data anonymisation may be problematic.
Researchers granted access to patient-level data from trials listed on the site will also have to sign a data-sharing agreement, with conditions relating to data privacy/confidentiality, posting summary results on internet registers/websites, seeking publication in a peer-reviewed journal, etc.
The initiative means researchers can submit a single proposal for access to studies of interest from multiple sponsors across multiple disease areas through a user-friendly portal, noted ideaPoint.
The company was launched around six years ago in Quincy, US to provide software solutions to pharmaceutical, biotechnology and medical-device organisations.
Scientific rationale
The Independent Review Panel will consider:
- The scientific rationale for the proposed research and its relevance to medical science or patient care.
- The ability of the proposed research plan (design, methods and analysis) to meet the stated scientific objectives.
- The publication plan for the research.
- Real or potential conflicts of interest that may affect the planning, conduct or interpretation of the research, as well as proposals to manage these conflicts of interest.
- The qualifications and experience of the research team
The Panel will then make one of the following decisions: approval for access to the requested data; approval for access to the requested data subject to conditions; rejection with advice to re-submit the research proposal; rejection of the research proposal.
There is no appeal process for research proposals turned down by the Panel.
Panel members
The initial members of the Independent Review Panel are:
- Dr Brian Strom (chairman), Professor and Chancellor of Biomedical and Health Sciences, Rutgers University, US.
- Marc Buyse, Associate Professor of Biostatistics, Hasselt University, Belgium and founder, International Drug Development Institute (US).
- John Hughes, Patient and Public Involvement member of the UK Clinical Research Collaboration Board, UK.
- Bartha Maria Knoppers, Canada Research Chair in Law and Medicine and Director of the Center of Genomics and Policy, McGill University, Canada.
Panel members were initially appointed for two years from the formation of the Panel in 2013. At the end of that term, the aim is to begin replacing some of the existing panel members on a rotating basis.
Panel Secretariat
There is also a Panel Secretariat comprising data-sharing co-ordinators (DSCs) from the sponsors involved in the initiative.
These DSCs will “not influence or make recommendations on research proposals reviewed by the Panel”, ideaPoint stresses.
Nor will sponsors be sent or will evaluate the reviews of research proposals by individual Panel members, it says.
Sponsors “do not influence individual Panel member’s reviews or overturn or change the decisions of the Panel”, ideaPoint states.
The ideaPoint portal is already listing a number of studies available from sponsors. Moreover, it has been designed with the flexibility to accommodate studies from other industry, academic and non-profit sponsors.
