Sharing clinical trial data: what it means for you

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.

Medicines and pins

Credit: Garo / Phanie / Science Photo Library

We want to make sure that clinical trial data, like data about the effectiveness of new drugs, can be accessed and used in ways that will advance medical science.

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

  1. Researchers seeking data can search the website to view the metadata of the listed trials. 
  2. To request data, a researcher completes a data access application form.
  3. 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.
  4. 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.

More information