Recent News that May Impact Clinical Trial Disclosure

Posted by Thomas Wicks on Jan 18, 2016 5:02:23 PM


INTRODUCTION:

With the serious Adverse Events, including one fatality related to the Phase I study in France last week, we expect to see an increased call for making information on Phase I trials publicly available.  AllTrials has already made a statement related to this event.


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Dr Ben Goldacre, co-founder of the AllTrials campaign for clinical trial transparency, said:

“We have a responsibility to do all we can to make phase 1 trials as safe as possible for those who are brave and altruistic enough to volunteer for them. That means learning from past mistakes wherever we can. The medical, academic and regulatory community have still not fixed the known problems around phase 1 trial transparency that were identified during the UK government’s own inquiry into the TGN1412 trial. We do not yet know what went wrong in this phase 1 trial in France. But for as long as we continue to allow dangerous secrecy to persist around such trials, we make these disasters more likely.

“The UK medical, academic and regulatory community must do all we can to ensure phase 1 trials are run as safely as possible. That means addressing all known, identified risks, including failure to share results.”

This push for publicly available posting of all clinical trials, including healthy volunteer studies, has previously been called for by the World Health Organization (WHO) and the World Medical Association (WMA). 

Information on clinical protocols related to Phase II – IV interventional trials have been made publicly available on various trial registries around the world for the last few years. 

  • In the EU, the protocol information for Phase I studies is submitted to the European Medicines Agency (EMA), but unlike Phase II – IV studies, the EMA does not make Phase I studies publicly available on the EU Clinical Trials Register.
  • In the US, sponsors are able to make Phase I studies publicly available on gov voluntarily.  A growing number of trial sponsors are making information on Phase I studies public, but it is not a regulatory requirement and often does not include the initial ‘healthy volunteer’ or Phase Ia studies. 


CONCLUSION:

As public scrutiny continues to pressure sponsors into moving toward greater clinical trial transparency, we can expect greater press coverage of incidents such as these and more voices to join the call for greater transparency, including Phase 1 studies.

 



 

Topics: Clinical Trial Disclosure