Global standards agreed for clinical trial reporting
There’s little doubt that the medical and pharmaceutical worlds depend on clinical trials to test the safety of new drugs, along with a variety of related medical items, and other therapies which may well benefit those afflicted with a variety of diseases and conditions. However, as vital as these trials are it seems not all lead to outcomes being openly reported and recorded.
Why is reporting weak?
It’s not entirely clear why around half of all clinical trials do not lead to the results being published and made available to others in the field, although there are indications this issue could be linked to those which produce negative results. Now, this is about to change following a commitment from those responsible for funding most medical research to ensure clinical trials they are connected to in any way are officially registered and publish openly accessible results.
The implications of this agreement
Having a dynamic group of medical research organisations such as the Wellcome Trust, the UK Medical Research Council, and the Médecins Sans Frontières research unit come together to work on policies to both shape and force change can only be a positive thing. It is expected that most clinical trial results will be published in a relevant journal, with more detailed findings being available elsewhere for others to consult and use.
The World Health Organisation (WHO) is tasked with setting and maintaining expected standards of commitment to this scheme, following its efforts to raise the ethical standards of clinical trial reporting. Its argument is that results which are shelved not only fail to add to the knowledge bank regarding a device, drug, or vaccine under development, but could even cause harm in the process, as important information regarding such things as side effects or contra-indicators could be overlooked – http://www.un.org/apps/news/story.asp?NewsID=56783#.WS0OU2jyu00.
Thorough QT studies organised by experts such as http://www.richmondpharmacology.com/specialist-services/tqt.php play a vital part in the development of drugs and treatments, so combining professional trials with full disclosure on outcomes is a very positive move forward.
Whether the results of a trial are positive and potentially life changing, or entirely unoptimistic, the priority must always be to produce and share honest results, as real progress happens when genuine outcomes are openly available to others researching in the field.