Global consortium is needed to manage access to patient-level data


Providing controlled access to identified patient-level information is an essential element of realising the full potential of clinical data stores. A global agreement is required to put in place formal mechanisms and ensure appropriate access, says Nicola Perrin, Head of Policy at the Wellcome Trust.

By Nuala Moran

Nicola Perrin 3

Nicola Perrin, Head of Policy at the Wellcome Trust

All researchers funded by Wellcome are required to maximise access to their data and clinical trials – including ones where the results are negative – are no exception. Specifically, this means all studies must be registered, and the summary results reported, on public registries such as

The debate around clinical trials transparency has provided a spur for the Trust to step up its monitoring process to check the researchers it funds are complying with these requirements, says Nicola Perrin, Head of Policy. Overall, she believes it is now generally acknowledged both by academics and industry that there is a duty to register and report trials.

This represents important progress in terms of transparency, but it still leaves much of the potential of clinical trials data under-exploited. There is now a need to put in place formal mechanisms for allowing access to patient-level data. “At present there are some ad hoc approaches. If we could get it right, this would reduce duplication, answer new research questions and stimulate innovation,” Perrin said.

Whilst the Wellcome Trust wants to encourage access to identified patient data, patient confidentiality remains the overriding concern. “This type of data should not be openly published; there should not be a free-for-all,” said Perrin. Some form of review process is needed, both to check the bona fides of researchers applying for access, and the scientific value of their proposed research. There are models here, such as the procedures for accessing a named individual’s samples and data from biobanks, which could form the basis of such a system.

The initial opening up of pharma industry clinical trial data stores, for example by GlaxoSmithKline and Roche, is happening at the level of individual companies, with each setting up its own panels to review research requests. A coordinated approach is required. “What won’t work is if everyone has their own system,” Perrin said.

Such coordination would allow research to be carried out linking separate industry sponsored clinical studies, and enable access to the relevant data sets via a single portal.

Over the past 12 months, the argument over clinical trials data transparency has moved in a positive direction. There is now agreement not only about listing and reporting trials on registries, but also on the value to be extracted from balanced and controlled access to patient-level data. “There is agreement transparency is right. The question is how do we do it, how do you get best practice?” Perrin said.

The Wellcome Trust is now involved in moves to promote the formation of a consortium to steer a system into place. This would apply to future trials. “There needs to be appropriate consent by patients, so the idea is to have something in place so we can get it right from now onwards,” said Perrin. “The consortium has to be global, it has to involve academics and industry, and has to cover the whole spectrum of clinical research.”

A roadmap for sharing clinical trial data

August 27th, 13:00 -17:00

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