Call for open access to all clinical trial data
pharmafile | October 6, 2011 | News story | Research and Development | Cochrane, clinical trials, clinical trials analysis
There should be free access to all clinical trials in order to end selective reporting, according to a leading not-for-profit research network.
The Cochrane Collaboration says the lack of laws forcing pharma-based researchers to publish findings from the clinical trials leads to “selective reporting” on investigational drug studies by companies.
This sees the industry only publish positive data for its drugs and leave out negative results for fear of damaging a drug’s potential.
But the Cochrane Collaboration, which publishes widely-respected data reviews and meta-analyses of available clinical trials, says this practice needs to end as it could be harming patients.
Cochrane urges changes in policy and law to make it mandatory for researchers to publish all data after a 12-month period, and it calls for punitive measures to be taken against those who fail to comply.
Peter Gøtzsche, director of the Nordic Cochrane Centre, said: “The over-riding objective of healthcare research is to improve patient care and health policy.
“It is pretty clear that if commercial concerns lead to the withholding of data that are important for rational decision-making by doctors and patients, there is something fundamentally wrong.”
The Collaboration said that selective reporting of trial results occurs frequently, leading to exaggerated findings of the beneficial effects of healthcare interventions and underestimates of their harms.
As a consequence, Cochrane says many patients are “unknowingly treated with interventions that have little or no effect, and may be harmed unnecessarily”.
This is unethical, they say, and violates the implicit contract between healthcare researchers and patients, where the aim of research is to improve treatment of future patients.
The Collaboration is calling for the following action to stop selective reporting:
- All randomised clinical trials to be registered at their inception, before recruitment of the first participant
- All data from all randomised clinical trials, including raw anonymised individual participant data that do not allow identification of individual participants and the corresponding trial protocols, to become publicly available free of charge and in easily accessible electronic formats
- Governments to consider introducing legislation requiring data from all trials to be made public within 12 months from the end of the randomised phase of the trial, in accordance with most international calls for data sharing
- Governments to also consider the following measures: punitive measures for non-compliance; a requirement to continue to hold and make available core data indefinitely, or to pass such data to a central and accessible repository; and recognition that ownership of trial data should be shared among sponsors, investigators and trial participants.
Ben Adams
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