Sharing clinical trial data: what it means for you
Explainer / Published: 17 May 2018
Wellcome has joined ClinicalStudyDataRequest.com (CSDR), a data-sharing initiative involving academic research funders and pharmaceutical companies. Jen O’Callaghan, from our Open Research team, explains why and what it means for researchers.
As a global research foundation, we’re dedicated to ensuring that the outputs of the research we fund – including clinical trial data – can be accessed and used in ways that will advance medical science by building on previous findings and exploring new questions.
CSDR is a website portal for listing and sharing clinical trial datasets. Originally established to provide a way for researchers to access trial data from a consortium of 15 pharmaceutical companies, CSDR has expanded to include data from academic-led trials.
Data continues to be held by the study team and is only shared with data requestors following a successful data access request.
Update to Wellcome’s policy on clinical trials
Today, we’ve launched an updated policy on clinical trials.
The policy now:
- makes it clearer what you need to do before, during and after you complete a trial funded by Wellcome
- brings our requirements into line with the WHO joint statement on public disclosure of results from clinical trials, which Wellcome signed up to in May 2017
- requires you to post summary results in the same registry as the one in which the trial was registered
- requires you to publish a trial protocol and statistical analysis plan before you start a trial.
Through the policy, we strongly encourage Wellcome-funded researchers to use CSDR for sharing trial data.
If you’re already funded by Wellcome, you’re encouraged to adopt our new policy, but it’s not a requirement. You must abide by the policy in place at the time you received your funding. The same grant terms and conditions will still apply.
How CSDR works
- Researchers seeking data can search the website to view the metadata of the listed trials.
- To request data, a researcher completes a data access application form.
- An independent review panel considers data access requests to ensure that the research plan is viable and the team requesting the data are able to handle the data in a responsible manner. The panel then decides whether access should be granted to the dataset(s) requested.
- A coordinator supports both the data generator and the requestor to share and gain access to the data.
The benefits of sharing data through CSDR
- Trial data that you have generated is more findable, accessible and reusable – helping to maximise its impact and value. You don’t have to establish your own data access mechanism or committee.
- CSDR provides an expert independent review panel to review data access requests at no cost to the requestor or the data provider.
- Help and support are provided for a range of activities including listing metadata on the website, managing queries from requestors, setting up a formal data-sharing agreement, preparing data for sharing and arranging data to be shared.
- It provides users with a single mechanism to access and analyse multiple trials from academia and industry – greatly reducing the barriers to re-use.
- It provides a means by which you can comply with funder and journal mandates and expectations regarding the sharing of clinical trial data.
Wellcome joined CSDR in March 2018. The Bill & Melinda Gates Foundation, Cancer Research UK and Medical Research Council have also joined.