Abstract
International calls for registering all trials involving humans and for sharing the results, and sometimes also the raw data and the trial protocols, have increased in recent years. Such calls have come, for example, from the Organization for Economic Cooperation and Development (OECD), the World Health Organization (WHO), the US National Institutes of Heath, the US Congress, the European Commission, the European ombudsman, journal editors, The Cochrane Collaboration, and several funders, for example the UK Medical Research Council, the Wellcome Trust, the Bill and Melinda Gates Foundation and the Hewlett Foundation.Calls for data sharing have mostly been restricted to publicly-funded research, but I argue that the distinction between publicly-funded and industry-funded research is an artificial and irrelevant one, as the interests of the patients must override commercial interests.I also argue why it is a moral imperative to render all results from all trials involving humans, also healthy volunteers, publicly available. Respect for trial participants who often run a personal and unknown risk by participating in trials requires that they - and therefore also the society at large that they represent - be seen as the ultimate owners of trial data.Data sharing would lead to tremendous benefits for patients, progress in science, and rational use of healthcare resources based on evidence we can trust. The harmful consequences are minor compared to the benefits. It has been amply documented that the current situation, with selective reporting of favorable research and biased data analyses being the norm rather than the exception, is harmful to patients and has led to the death of tens of thousands of patients that could have been avoided.National and supranational legislation is needed to make data sharing happen as guidelines and other voluntary agreements do not work. I propose the contents of such legislation and of appropriate sanctions to hold accountable those who refuse to share their data.
Highlights
International calls for registering all trials involving humans and for sharing the results - and sometimes the raw data and the trial protocols - have increased in recent years
I argue why data sharing would lead to tremendous benefits for patients, progress in science, and rational use of healthcare resources based on evidence
My paper aims at convincing those who have doubts about whether we should share our research data. It is less focused on practical or legal difficulties, which can always be resolved if there is a willingness to resolve them, but I do suggest the introduction of a new law about data sharing and sanctions in case the law is violated
Summary
International calls for registering all trials involving humans and for sharing the results - and sometimes the raw data and the trial protocols - have increased in recent years. Access to raw data would make meta-analyses of trials studying similar interventions and patient groups much more reliable than if based on published summary data It would allow exploratory analyses aimed at identifying subgroups of patients where the treatment would be beneficial or where it might be harmful, resulting in much more cost-effective and evidence-based use of interventions, with large savings for our societies. The same rules ought to apply to industry-sponsored trials as to publicly-sponsored trials, which would help re-instate public trust in industry-sponsored research, which is at a historically low level at present [113] This can only occur if the industry discloses all protocols, results and raw data from all studies in humans, including those in non-patient volunteers who may suffer the harm of the drugs [11,114]. Any violation of the law should mean that new projects from the same sponsors or researchers cannot be approved by the research ethics committees until all data from previous studies have been made public
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