Alastair Kent, Director of Genetic Alliance UK

“There’s absolutely no point in having a polarised debate where people are standing on soap boxes and shouting at each other,” says Alastair Kent, Director of Genetic Alliance UK, a body representing more than 160 rare diseases patients’ groups, commenting on the current impasse in Europe over opening up access to clinical trials data.

“You are going to end up in a situation where patients lose rather than gain because the pace of development slows and undue attention is given to any problems with a drug, rather than the benefits.”

The way forward is to recognise that both patient confidentiality and commercial confidentiality must be factored in to any equitable and practicable clinical trials data transparency system, but that one cannot trump the other, that neither is absolute, and – in particular – that the industry cannot use patient confidentiality as a “magic shield” to avoid answering awkward questions, Kent says.

“Fundamentally, I, and I think most patients’ groups are in favour of transparency. But that does not mean putting everything in the public domain for anyone who wants to look at it.”

The approach taken in rare diseases provides a model for how to move forward, and will be increasingly useful as the advance of personalised medicine leads clinical trials of drugs for treating common, complex, chronic diseases to be stratified into small subsets of patients.

Patients with rare diseases want the maximum value possible to be extracted from any samples and data they contribute to clinical studies. They are also keen to be on rare disease registries set up to promote research, increase understanding of the natural history of a rare disease, and for identifying patients who could participate in a clinical study.

“When setting up a registry, all sorts of things need to be taken into account and incorporated into the original consent document. By participating in a registry you know data and samples will be available for research purposes, and you also get the benefits of visibility,” said Kent.

As Kent noted, those allowed access to registries could be public sector academics, but given rising commercial interest in rare diseases, they could equally be pharma companies, highlighting the fact that a proportionate data transparency regime should not exclude competitors from getting access to data.

Methods for providing access without compromising an individual’s privacy already work in practice. Kent pointed to researchers who get grants from the UK Economic and Social Research Council being required to place their raw data in secure archives. Similarly, resources such as the UK Biobank and the 1000 Genomes Project, which relate to named individuals, will be open for public and private researchers who demonstrate appropriate credentials.

“There are models for allowing data transparency, while protecting individual and commercial interests. It’s fair enough to share non-identified, pooled data in the public domain, alongside secure data archives that are accessed by approved researchers,” said Kent.

Overall, “You can’t allow one side or the other of this argument to win,” Kent believes. “If the rules are too draconian you will prevent discoveries from happening. If things are too laissez-faire, with no respect for commercial confidentiality there’s less incentive to invest and a risk the regulatory system gets undermined,” he said.

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A roadmap for sharing clinical trial data

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