| An open letter to all US Presidential candidates
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Medical experiments on humans [clinical trials] are carried out in the hope of improving health and furthering science. By their very nature they entail uncertainty about potential harms and benefits of a treatment or a procedure. This is why following WWII, prior ethics review by an independent committee has gradually been introduced as a key condition. No benefit can be derived from trials which are either invisible or reported partially or selectively. To avoid this risk, a growing number of organisations have made efforts to allow access to clinical trial results in a detail hitherto unknown. Despite the growing international effort and a notable legislative effort in the EU, the US lags behind. Study results posted on clinicaltrials.gov are, by definition, incomplete and unverified. Even so, eight years after the introduction of federal law FDAAA 2007 a very small number of results of registered trials have been made available and updated. No detailed regulatory documents are available from the FDA. Physicians and patients require access to clinical study reports and anonymized individual patient data from trials of approved drugs and biologics. US law and regulations globally affect organizational and professional behaviors with huge impact on health worldwide. The international composition of this letter’s signatories reflect this reality. We call for a statement by all US presidential candidates on whether they support access to clinical trial data held by federal agencies, irrespective of topic, sponsor, country in which the trial was run or results. We ask that they state what measures they would put forward, if elected, to address the scandal of invisible and distorted clinical trials.
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Kudos to Tom Jefferson for drafting our consensus letter to the presidential candidates published today in the British Medical Journal. I feel honored to be included in this list of heavyweights. Some may think that such gestures are ineffective, but I disagree. We’ve had years of silence and the results speak for themselves. Now people are speaking out, there’s movement – actually fairly rapid movement for the usual pace of things in medicine and science.
A university and clinical trial investigators must release data to a citizen-scientist patient, according to a landmark decision in the UK. But the decision could still be overturned if the University and investigators appeal. The scientific community needs the decision to be upheld. I’ll argue that it’s unwise for any appeal to be made. The reasons for withholding the data in the first place were archaic. Overturning of the decision would set a bad precedent and would remove another tooth from almost toothless requirements for data sharing.We didn’t need Francis Collins, Director of National Institutes of Health to tell us what we already knew, the scientific and biomedical literature is untrustworthy.And there is the new report from the UK Academy of Medical Sciences, Reproducibility and reliability of biomedical research: improving research practice.
There has been a growing unease about the reproducibility of much biomedical research, with failures to replicate findings noted in high-profile scientific journals, as well as in the general and scientific media. Lack of reproducibility hinders scientific progress and translation, and threatens the reputation of biomedical science.
Among the report’s recommendations:
Numerous governmental funding agencies and regulatory bodies are endorsing routine data sharing.
The UK Medical Research Council (MRC) 2011 policy on data sharing and preservation has endorsed principles laid out by the Research Councils UK including:
Publicly funded research data are a public good, produced in the public interest, which should be made openly available with as few restrictions as possible in a timely and responsible manner. To enable research data to be discoverable and effectively re-used by others, sufficient metadata should be recorded and made openly available to enable other researchers to understand the research and re-use potential of the data. Published results should always include information on how to access the supporting data.The Wellcome Trust Policy On Data Management and Sharing opens with:
The Wellcome Trust is committed to ensuring that the outputs of the research it funds, including research data, are managed and used in ways that maximise public benefit. Making research data widely available to the research community in a timely and responsible manner ensures that these data can be verified, built upon and used to advance knowledge and its application to generate improvements in health.The Cochrane Collaboration has weighed in that there should be ready access to all clinical trial data:
Summary results for all protocol-specified outcomes, with analyses based on all participants, to become publicly available free of charge and in easily accessible electronic formats within 12 months after completion of planned collection of trial data; Raw, anonymised, individual participant data to be made available free of charge; with appropriate safeguards to ensure ethical and scientific integrity and standards, and to protect participant privacy (for example through a central repository, and accompanied by suitably detailed explanation).Many similar statements can be found on the web. I’m unaware of credible counterarguments gaining wide acceptance. Yet, endorsements of routine sharing of data are only a promissory reform and depend on enforcement that has been spotty, at best. Those of us who request data from previously published clinical trials quickly realize that requirements for sharing data have no teeth. In light of that, scientists need to watch closely whether a landmark decision concerning sharing of data from a publicly funded trial is appealed and overturned…
Thank you so much for the work you’re doing to make data from drug studies. “Because we said so” doesn’t really cut in the sciences.
cut it