December 8, 2011
I heard a powerful case recently for access to all clinical trial results. The case was made by Professor Peter C. Gøtzsche, leader of the Nordic Cochrane Collaboration in Copenhagen and one of those whose complaint to the European Ombudsman has led to major improvements in transparency in the European Medicines Agency.
The occasion was a seminar in the European Parliament on the EU Horizon 2020 Research Programme, organised by Health Action International (HAI) and the Transatlantic Consumer Dialogue (TACD) – of which I am proud to say I was one of the founding members in 1998.
A brief summary and a link to a recording of the seminar are available here
Access to clinical trial data, or data sharing, would mean that the results (positive or negative) of all clinical trials would be published, and that the (anonymised) raw data from all trials would be openly available to other researchers, together with the protocols (purpose, objectives, methodology etc) for each trial.
Without data sharing, what gets published is likely to be selective if not actually misleading, unwelcome but important results may be concealed, presentation wins over substance and patients, doctors and and health authorities have an inadequate or even flawed evidence base for decision making. Selective publication is bad science.
Referring to recent cases, early data sharing would have prevented thousands of avoidable and unnecessary deaths arising from the Merck medicine Vioxx, according to Professor Gotsche. On Tamiflu, the medicine developed for the flu pandemic a few years ago, he said that we know very little about its effect, efficacy or possibilities of complications, because the company has refused to share much of the information it has on the subject – and presumably the information that is shared is likely to be relatively positive about Tamiflu. As a result policy was developed on an inadequate evidence base.
In brief, the case for data sharing is as follows:
– It would save millions of euros, improve health and longevity in the population and reduce harm.
– It would improve research quality.
– It would lead to better information for patients, doctors and governments to make more rational decisions on medicines.
– It would enable more medicines research to be done at relatively little extra cost.
– Data sharing would help to avoid “redundant” medical trials, which by their nature are unethical, on issues for which relevant data already exists.
– Data sharing would reduce incentives to bias and selectivity in clinical trials.
– It would lead to better science and a better evidence base for decision making.
– Data sharing is a duty researchers owe to clinical trial participants, for the risks they take, to patients generally and to taxpayers who fund health and research infrastructures and the re-imbursement of medicines.
Acknowledging recent progress in the European Medicines Agency, Professor Gotzsche said the same standards should apply to the national medicines agencies. (Here, the UK Medicines Agency was cited as one of the worst and most secretive of the national agencies, and where data is destroyed after fifteen years.)
He also argued that legislation was needed to achieve data sharing. I agree with this. This could be done in 2012 in the planned revision of the Clinical Trials Directive.
Another worthwhile suggestion was that the EU Horizon 2020 research programme should fund a range of systematic reviews of medical research results on selected topics, in order to maximise the value of the (expensive) research carried out to date. ENDAuthor : Jim Murray