The RSS has reaffirmed its support of open data in clinical trials in the light of recent developments that may lead to data from clinical trials of pharmaceuticals being more readily available.
In September this year, doctor and columnist Ben Goldacre published his second book, Bad Pharma, which is heavily critical of the availability of clinical trial data, or lack thereof, regarding certain pharmaceuticals. In a recent interview, Goldacre stated: ‘We need to make sure that all results from all clinical trials are always published, with no exceptions. What’s more, we need to go and dig up all the results from trials that were run in the past, because those are the trials that were done on the drugs that we are currently using.’
In October, GlaxoSmithKline announced
that from January 2013 it will allow researchers to have access to data relating to its clinical trials, subject to approval from an independent panel of experts. Trial data collected since 2007 will be placed on a password protected website and earlier data, in non-digital formats, would be made available on ‘an ad hoc basis’.
The British Medical Journal’s editor-in-chief, Fiona Godlee, praised GSK’s decision
and said medical journals ‘could leverage their power and publish only where there is a commitment to make the relevant anonymised patient level data available on reasonable request.’ She announced that as of 1 January 2013, BMJ would only publish clinical trials of drugs for which full data are openly available.
Availability of social and scientific data has long been championed by the RSS; back in June 2011 the Society issued a statement on the matter
, saying that it was ‘crucially important that the results of scientific research should be made publicly available and disseminated as widely as is practical in a timely fashion after completion of the scientific investigation.’ The RSS statement also stressed that ‘decisions to publish should not be based on whether research findings are “positive” or “negative”’.