Should Clinical Pharma Trial Data Be Made Public?

Sunlight has a generally positive impact on everything, but especially when it comes to data.  JL

The Financial Times comments:

The proportion of trials that remains unpublished is hard to estimate but may be as much as half. Negative results are naturally less likely to be published than positive ones — skewing the whole evidence base underlying medical practice.
The much needed drive to open the results of clinical trials to public scrutiny is gathering momentum. Last week 85 institutional investors threw their weight behind activists demanding more transparency in pharmaceutical research; this week 50 patient and medical organisations in the US will add their voices to the international AllTrials campaign.At issue is the longstanding failure by researchers, in industry and universities, routinely to release the results of studies in which people are subjected to experimental drugs and other medical interventions. The proportion of trials that remains unpublished is hard to estimate but may be as much as half.
Negative results are naturally less likely to be published than positive ones — skewing the whole evidence base underlying medical practice. While regulators such as the US Food and Drug Administration and European Medicines Agency receive details of all clinical data used to support applications to introduce new drugs, these are not routinely released for scrutiny by the wider world of medicine and academia. And trials of failed and abandoned drugs may not even reach the regulators, let alone the outside world, although understanding the reasons for failure could help scientists to develop safer and more effective medicines in future.
In the pre-internet era, when everything was published on paper, partial and biased dissemination of trial results was inevitable. The process then depended on medical journals, whose editors preferred to select papers that came to positive or surprising conclusions over those showing that an intervention worked poorly.
Journal editors today have similar preferences but scientists no longer depend on them to release results. Several specialist websites with open access exist for researchers first to register clinical trials before they begin and later to post the results for others to view; the largest is clinicaltrials.gov, maintained by the US National Institutes of Health.Pressure to use such facilities is growing, as medical academies, funding agencies and international organisations join the campaign. The World Health Organisation made a timely declaration this year that researchers have an ethical duty to report all clinical trial results, including those of unpublished past studies.
The pharmaceutical industry’s response has been mixed. Plaudits go to GlaxoSmithKline, which publishes all current trial results and is progressively releasing data from old trials. Johnson & Johnson and Bristol-Myers Squibb are doing well too. Unfortunately, several other drug companies insist that a commitment to full publication could undermine commercial confidentiality — an argument that GSK’s example shows to be bogus.
Legislators and regulators must also take clinical trial transparency more seriously. In the US the FDA has failed to exercise its power to fine companies that do not report results within a year of the trial’s completion. In Europe a welcome EU regulation will require the registration and publication of trials from 2016 — though here too there are doubts about how vigorously it will be monitored and enforced.
Transparency brings obvious dividends for society as a whole, including avoiding unnecessary repetition of fruitless research and making a treasure trove of existing data available for reanalysis and innovation. But drug companies should also recognise the business case, that clinical openness reduces risk and increases investor confidence. Open data will benefit all, from patients to shareholders.