The Ethical Medicines Industry Group has weighed into the debate over data transparency that has again come to the fore following a UK Parliament report into stockpiling of Roche’s Tamiflu and a more general look at access to clinical trial information.
At the end of last week, the House of Commons Public Accounts Committee issued a hard-hitting report saying it was “surprised and concerned to discover that information is routinely withheld from doctors and researchers about the methods and results of clinical trials on treatments currently prescribed in the UK”.
EMIG represents the interests of over 200 mainly small to medium-sized companies and organisations based in the UK and chairman Leslie Galloway said the body welcomes the PAC’s calls to improve transparency. However, it has concerns that the report “fails to take into account the totality of organisations that perform clinical research to enhance the understanding of a medicine’s effectiveness throughout its entire lifecycle”.
Mr Galloway stated that “the true nature of a medicine’s effectiveness…can only be made after it is approved by a regulator and made available to the markets worldwide. This enables further clinical trials to be done by the inventor company, sometimes because of regulatory requests or for marketing reasons, but also, importantly, by national publicly-funded bodies and academia”.
As such, he argues that “an inventor company often has little or no control over the design or conduct of the latter group of studies, yet it is these that add significantly to the totality of evidence about an individual medicine’s effects”. Often, these studies investigate these effects “in a much wider context of a therapeutic landscape than is possible at the initial regulatory stage of marketing approval”.
Mr Galloway concluded by saying that EMIG is keen to work with all stakeholders “to develop and implement a transparent clinical trials system and recognises that, while industry must improve, the onus must be on everyone involved in the clinical trials process to do the same”.
