Scientists and policy makers need all the evidence to make informed decisions about medicines but drug research is an area where privacy concerns and transparency are in conflict.
Like all areas of research, trials with positive results are likely to be published but even then half of all trials for the treatments being used today have gone unpublished. Government officials have seen the studies but not the wide community, with some exceptions. GlaxoSmithKline, the world's fourth largest drug company, has committed to share all Clinical Study Reports going back to the foundation of the company, as part of the AllTrials campaign.
There is legislation mandating greater transparency, such as the U.S. law requiring trial results for potential new medicines to be posted on ClinicalTrials.gov.
Since 80% of the medicines prescribed this year came onto the market more than a decade ago, Ben Goldacre, blogger, author and research fellow at the London School of Hygiene and Tropical Medicine, calls for trials from the past to be fully disclosed.
John Castellani, President of the Pharmaceutical Research and Manufacturers of America (PhRMA), says mandatory disclosure could affect patient privacy, stifle discovery, and allow competitors or unscrupulous actors to use the information. Threats to patient privacy "will jeopardize patient willingness to participate in clinical trials, which would delay the availability of new therapies.
"The biopharmaceutical industry is firmly committed to enhancing public health through responsible reporting and publication of clinical research and safety information," he writes.
Rather than forcing the issue and allowing too much privacy he says industry is "engaged in a dynamic ongoing process to improve on all aspects of clinical trials" ans that should take its course.
Are regulators not enough?
Would science and medicine be improved if the public, trial lawyers and anti-medicine activists had access to all trial data, or would it lead to more promotion of fear and doubt by advocacy groups exploiting lack of knowledge to advance an agenda? Goldacre sides with more transparency, saying there is greater chance of "real and unnecessary risks" when only regulators see all the information on trials - because problems with evidence are also identified by academics and doctors working outside of regulatory bodies.
He says that Clinical Study Reports – long documents held by regulators and companies on the full methods and results of trials – should be shared publicly, with information about individual patients redacted where necessary. He says that 1.6 million pages of this material have already been shared by the European Medicines Agency (EMA).
On the issue of patient privacy, he does not call for individual patient records from trials to be published openly, but does point to several examples of "sensible and cautious sharing of [these] detailed datasets" among professionals.
The problem of missing trials "is one of the greatest ethical and practical problems facing medicine today," writes Goldacre. "The AllTrials movement is driving the solution forwards: patients need industry to engage constructively with this widespread consensus, on the practical details – urgently – so that we can all move on."
Castellani disagrees. Mandatory public disclosure of clinical trial information, without appropriate scientific and clinical context, could undermine patient trust and confidence in the safety and effectiveness of approved medicines, he writes.
He also raises concerns over disclosure of intellectual property, confidential commercial information, and proprietary scientific methods found in clinical trials, saying this "could stifle discovery and open the possibility of competitors or unscrupulous actors using the information for their own products in other markets or countries."
He outlines the huge investment and "considerable risk" involved in the search for new treatments, and concludes that "only a carefully balanced regulatory and competitive environment can foster the future investments in this research necessary to produce new treatments to benefit current and future patients."