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Sharing clinical trials data: A patient-centred perspective


As a patient, I want to know that the medicines prescribed for me do what they are supposed to do, are unlikely to cause me serious harm, and that the research that has led to the conclusion has been thorough, conducted appropriately on a sufficiently representative sample for these conclusions to be reasonable one to draw.

Historically, industry and Regulatory Authorities have conducted their dialogue behind closed doors and under a veil of secrecy (often concealed behind a cloak of “patient and commercial confidentiality”). Patients have just had to trust that the system is working properly on their behalf. On the whole, this system has worked more often than it has not, but there have been many examples of drugs being withdrawn after licensing when unanticipated harms have come to light. In recent years, patients and patient organisations have become increasingly involved in the processes of designing and undertaking of clinical trials. These two factors, coupled with the emergence of developments such as “adaptive licensing” and similar changes in the regulatory framework, mean that patients have a legitimate expectation that they will have a say in the “benefit/risk” calculation that ultimately leads to a licensing decision. This inevitably requires access to the data that has been generated by the clinical trials.

This trend is one that patients and patient organisations generally welcome. Greater transparency will bring about greater confidence and help build sustained trust in the drug development and licensing framework. This is not to say that there should be unfettered access to raw data generated by clinical trials. There are genuine concerns about protecting patient confidentiality, particularly when therapies for rare diseases or drugs using a stratified medicine approach are in the frame. As the selection criteria for trials become more and more specific – for example specifying the presence or absence of a particular disease causing mutation in an already small patient population with a rare disease – so the risk of inadvertent disclosure of information that will permit individuals to be identified increases unless safeguards are put in place. However “patient confidentiality” should not be used as a trump card that prevents appropriate disclosure of trial data to those with a legitimate interest. Similarly claims of commercial confidentiality should be scrutinised, with a rebuttable presumption in favour of transparency rather than the other way round. In other words the expectation should be that data should be accessible unless a case can be made for confidentiality, rather than the other way round.

Properly managed, data sharing builds trust, increases confidence and will promote greater engagement in the development and delivery of innovative therapies that respond effectively to the unmet needs of patients with serious diseases.

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Written by


Director of Genetic Alliance UK

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