Clinical trials: what are we not being told?

Clinical trials are a fundamental part of the Research & Development of medical treatments and the advancement of medical science. The World Medical Association’s statement of ethical research principles The Declaration of Helsinki, sets out that medical research should be registered that researchers have a duty to make publically available their results and that they are accountable for the completeness and accuracy of their reports, including negative and inconclusive results.

However this does not always happen. In fact it rarely happens within obligatory timeframes such as in US where most treatments approved by the US Food and Drug Administration (FDA) are required to register trial summary results with one year of completion; a New England Journal of Medicine (NEJM) study found that only 13.4% of trials complied with this legal requirement.

Research that is being conducted but is not reported can contribute to at best repetition of trials and medical science being held back and at worst the wrong medical decisions being made for a patient.

In 2013 The AllTrials campaign was launched and calls for all past and present clinical trials to be registered and their results reported. Transparency International UK is pleased to support the AllTrials Campaign. Transparency International UK believes that Research & Development should be undertaken in a manner that is transparent avoids conflicts of interest, and places the best corruption-resources-corruption-resources-healthcare outcomes at the heart of decision-making. This is one of the main objectives of Transparency International’s Pharmaceuticals & Healthcare Programme.

Transparency International also believes that disclosure in Research & Development should go further than clinical trials.  That means more transparency in a number of areas by clinical research organisations private sector pharmaceutical companies and private investors, academic institutions, and national and regional corruption-resources-corruption-resources-health regulatory authorities.  This will help us ensure that ethical standards are raised, there is greater objectivity in research and more sunlight in the system, including disclosure of sources of funding.  Corruption thrives in dark corners.  Transparency is not the full remedy, but is a vital step.

The AllTrials campaign was launched in January 2013 and calls for all past and present clinical trials to be registered and their results reported. It is an initiative of Bad Science BMJ Centre for Evidence-based Medicine Cochrane Collaboration James Lind Initiative PLOS and Sense About Science and is being led in the US by Dartmouth’s Geisel School of Medicine and the Dartmouth Institute for Health Policy & Clinical Practice. Since then the AllTrials petition has been signed by 84143 people and 562 organisations.

Author – James Sale, Project Officer, Transparency International’s Pharmaceuticals & Healthcare Programme