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Assessing the research potential of access to clinical trial data

17 Mar, 2015

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Access to the data generated by clinical trials is key to realising the full benefits of trials of new health interventions, and a valuable opportunity to generate new insights. There has been much recent discussion of how to maximise the impact of sharing of data from clinical trials, and with our track record of encouraging open access and data sharing, the Wellcome Trust is fully engaged with the issue. To help inform these discussions, we commissioned an independent study to look at research potential of increased access to trial data, and what mechanisms are needed to facilitate it. Will Greenacre, from the Wellcome Trust policy team, discusses the findings…

Clinical trials take place every day all over the world to test the safety and effectiveness of new medicines and other health interventions. Not only are trials central to the development of new treatments, but the data they generate can also be a valuable resource to others – both for testing the existing evidence, and for generating new insights to drive research.

However, while many researchers already share their data informally, there are few established mechanisms to enable data sharing on a larger global scale. Many datasets are not accessible to researchers who might want to analyse them, and in many cases researchers may not even know that data exists. The Wellcome Trust is keen to encourage transparency and data sharing in research. This has to be done in an effective and responsible way that benefits research, while also protecting the safety and privacy of participants.

Aim of the study

To help inform on-going discussions in the international research community around the development of new models for data sharing, the Wellcome Trust commissioned independent consultants Technopolis to carry out a study into the types of novel clinical research that are already being undertaken using data from existing trials, and to develop case studies and examples. We also asked them to look at the existing demand for access to data in the international research community, and what mechanisms are needed to enable more efficient sharing of data.

The project team carried out a survey of researchers, data managers, company representatives and others with an interest in data access, and followed this up with a series of interviews to explore the responses in more detail.

The results

The main findings were that data from existing trials is already helping to inform research in ways that are leading to tangible health benefits. This includes the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG), which has used meta-analyses of clinical trial data to generate evidence on the efficacy of tamoxifen treatment for breast cancer, which has been adopted into guidelines for treatment of women with early breast cancer around the world.

They also found that enhanced access to trial data clearly has the potential to drive new clinical research in other directions, and that there is a real demand within the research community for access to data. This includes data from both academic and commercial clinical trials together  (70% of survey respondents cited this as ‘significantly important’ or ‘essential’).

Data sharing KAG3

Key recommendations

There are some barriers to enhanced access, and the report sets out some recommendations for how to address them – with a particular focus on joining up existing data sharing initiatives. The recommendations are:

  • Link current data sharing initiatives and prevent further fragmentation of data landscape – through promoting establishment of larger data repositories and supporting linking of existing repositories and data portals
  • Establish a central information website, or consider adapting current clinical trial registries, with profiles and links to existing repositories and data portals to enhance discoverability
  • Establish a central repository or data portal to facilitate access to individual patient data from clinical trial data
  • Establish a global discussion forum of potential funders of individual patient data sharing initiatives to develop global support and a joined-up approach leading to the implementation of globally “linkable” repositories and data portals

The findings of this report are timely. In January the US Institute of Medicine (IoM) published a report of its study into strategies for the responsible sharing of clinical trial data (the Wellcome Trust was a sponsor of this work).

The Technopolis report ties in well with the IoM report’s conclusions, especially that a global consortium should be established to promote data sharing more broadly, and that we need to address the challenges involved. The study also provides useful data on what researchers think about data sharing, what barriers they would like to see addressed, and some directions for further work to inform new data sharing models.

We will be continuing discussions to take forward the report’s recommendations and to advance the data sharing agenda more broadly so that the full potential of clinical trial data to inform research can be realised.

You can read the Technopolis report in full on our website and find out more about the Trust’s role in taking forward efforts to increase access to clinical trial data.

 

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