Making clinical trials data sharing easier

Access to and re-use of data is crucial for maximising the value of the investments that we make, which is why we’re supporting ClinicalStudyDataRequest.com to make it easier for you to share your clinical trial data. We recently caught up with the staff at our Southampton Clinical Trials Unit to hear what they think of the platform.

As a charity funded by donations and volunteers, our supporters expect us to do everything to ensure our investments beat cancer sooner. One current area of focus for us is data sharing, which we know has huge potential to drive innovation and further discovery.

At CRUK, we expect all our researchers to appropriately share the data they generate. We ask applicants to supply a data sharing plan, outlining how they will manage their data and make it available to the research community. Our funding committees expect to see applicants planning timely and responsible sharing of data arising from their research, including clinical trial data, and will assess applications accordingly.

We also know that, as a funder, we have a role in ensuring that suitable infrastructure is in place to enable data sharing, and that barriers and disincentives to data sharing are addressed. Last year, we joined the consortium supporting ClinicalStudyDataRequest.com (CSDR), a platform that aims to improve clinical trial data discoverability and sharing. If your clinical trial is funded by us, you can now list your study on the platform for free.

What is ClinicalStudyDataRequest.com?

  • CSDR is not itself a data repository, but a directory listing and searching studies for which data sharing is available
  • The data are held by the team that carried out the study and will only be shared with other researchers following a successful data access request
  • Currently there are almost 4,000 studies listed, and over 400 research proposals requesting access to data have been submitted
  • Studies listed include those from industry and academic funders – including Wellcome, MRC and the Gates Foundation

 

We caught up with Susannah Condie, Head of Data Management at our Southampton Clinical Trials Unit (SCTU), and Professor Gareth Griffiths, Director of the SCTU, to find out how CSDR is facilitating data sharing and discovery. Susannah and Gareth were the first users to list an academically-led clinical trial on the platform.

What’s your experience of data sharing in clinical research?

Data sharing has always been important to us at SCTU. Not only can it drive further discovery, it’s also good research practice because it enables validation of key findings and reproducibility of the results. This is especially important in clinical research, where results from clinical trials can directly impact on patient treatment and care.

Collaboration within the academic clinical research community and with pharmaceutical companies is becoming a key aspect of UK clinical research. We therefore feel it is important that clinical trials units have a documented, transparent process with guidance for data sharing requests; which is implemented within the context of the legally defined contractual agreements associated with specific trials and sponsors.

In an era of transparency and desire for data sharing we believe it reasonable to consider sharing of data with trial collaborators and subsequently with external researchers requesting access to data. We provide data access if data sharing is for legitimate research purposes and is approved by a suitable review panel.

Why did you list your clinical trial on CSDR?

We’ve always had a data sharing process and a statement on our website explaining how researchers can request data access from SCTU. After CRUK joined CSDR we decided to list one of our recently completed trials on the site. Journals are increasingly asking for statements on how to access a publication’s data, so having CSDR as a common front end to deal with requests for this trial was logical – it makes our lives easier.

Our CRUK trial assessed a combination therapy of ipilimumab with standard first line chemotherapy for Small Cell Lung Cancer. We chose to list this trial on CSDR because the patient informed consent allows us to share the data with third parties. We’re now preparing to list other completed trials on the platform.

Can you tell us about your experience of using CSDR?

Using CSDR has been easy and straightforward. Listing the trial on the website and updating the CSDR spreadsheet with appropriate information are very simple steps to follow.

Information about our clinical trial is now available to researchers, including industry partners, who have access to the CSDR web site. We haven’t received a data access request through CSDR yet, so we’re still looking forward to comparing the review and approval process to the one that we’re used to. But having looked into the Independent Review Panel and data sharing agreement process that CSDR has in place, we’re hopeful that these will also make our lives easier.

What are the main barriers to clinical data sharing and how can CSDR help?

Our top concern in clinical data management is always protecting patient confidentiality. Patients can only give informed consent to participate in defined research and to give their data to defined recipients. This means that only fully anonymous data can be shared unless requested by one of the defined recipients.

However, to transform data to fully anonymised comes with a cost, and who should bear this cost is often unclear. With this initiative, CRUK will help prepare data for sharing and cover some of the costs associated with de-identification.

Some researchers still raise concerns about the general idea of data sharing. We hear people’s concerns about losing control of what happens with the data once released, or not being appropriately recognised for their contribution in subsequent work. CSDR can help dispel these concerns, because data are only made available after a data sharing agreement is signed by the data generators and requestors. As a data generator, you’ll be able to negotiate the details of the data sharing agreement, including how you should be acknowledged in subsequent publications, and limits on the use of the data.

CSDR can also help filter out inappropriate requests to access the data. Data requests and research proposals for use of the data are assessed by the CSDR Independent Review Panel.

What’s your final verdict?

After our very positive experiences with CSDR, we’ve updated our processes at SCTU so now we just list the trial in CSDR as part of the process of closing our trials.

We have some high hopes for the platform and the possibilities that arise as it grows and matures. There is a great potential for the platform to support not only data re-use and comparative studies, but also meta-analyses on much larger pools of data, which provide the highest level of evidence.

We have entered the era of transparency and data sharing in research, and it will only become more normal to share clinical research data. After all, we owe it to our clinical trial participants to maximise the knowledge gained from their efforts and sacrifices, so that we can bring new approaches to treatment into the clinic faster.

 

For more information about CSDR, or if you’d like to list your trial, contact us at PRC@cancer.org.uk or visit ClinicalStudyDataRequest.com.

 

In this article

Susannah Condie is Head of Data Management at CRUK Southampton Clinical Trials Unit and a clinical operations professional with 30 years' experience across academia and pharmaceutical research development, specialising in clinical trial data management, information systems, data sharing, performance analytics, vendor management, capability development, project management and medical information.

Professor Gareth Griffiths is the Director of the CRUK Southampton Clinical Trials Unit and Professor of Clinical Trials at the University of Southampton. Southampton CTU is a CRUK core-funded CTU which develops early- and late-phase clinical trials in many cancer areas including lymphoma, upper and lower gastrointestinal tract, urology and immunotherapy.

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