If you are interested to find examples of the consequences of not reporting the results of clinical trials, then look no further than
Ben Goldacre and his book Bad Pharma (2012)
If you saw the recent BBC programme about the clinical trial (anti-CD28 antibody) that went wrong (what a pile of Pants! the programme), then the alarm bells should have been ringing.
This is because doing a similar thing was tried years before in humans and caused the same problem but the academic (not pharma) doing that trial did not report and publish the work.
This could have saved six guys from a lot of problems and one guy would have their fingers and toes still.
Ben Goldacre suggests a number of things to encourage pharma to publish the results within 1 year of completion of the trial,
I say "If the regulators implemented a requirement to publish the trial data on clinical trial.gov or they could not file for another trial. This is a stick to make change as carrots don't seem to work. Would it cause all trials to be published?
There is a UK website called research fish were each UK government grant has to have output recorded for 5 years after completion of the grant, with the threat of no more funding if you don't complete it...will they have teeth to do this..
Many trials don't complete on time, and then would have the data appearing on clinical trials.com before publication of the trial results. However these aspects could be addressed. Would a stick work
Probably not, because the (UK) regulators are paid for by pharma and are not going to bite the hand that feeds them.
If the Eli Lilly failed, it is informative, if it made people worse it is informative and then scandelous that it was not reported.
The Merck trial of ataceicept (anti- BAFF & APRIL) was reported as recruiting in March 2008 and it was terminated, because if made people worse in Sept 2009.
The Lilly trial on talabumab (anti-BAFF) was reported starting April 2009 and recruiting was reported complete in Sept 2010. So it was recruiting a full year after the atacicept trials...yes there were two, were terminated.
Their is data not yet published from the atacicept trials that may allow us to try and understand the apparent failure better, we know this becuase of the protocol.
Labels: Bad Pharma