EMA and industry clash over clinical trial transparency

Three_wise_monkeys_figure The war over clinical trial transparency has escalated, with the European Medicines Agency (EMA) and pharmaceutical company AbbVie clashing over what data are “commercially confidential”.

AbbVie, which has sued the EMA to stop it publishing the clinical data relevant to its regulatory decisions, told the regulator that details of a company’s clinical trial design and outcomes should be protected.

Hans Georg Eichler, the EMA’s Senior Medical Officer, declared himself “totally flabbergasted” by the assertion.

The EMA, as instructed by the European Ombudsman, has declared that from January 2014 it will make details of clinical trial studies submitted to it for regulatory purposes available to public information requests.

However, US companies AbbVie and MedImmune have legally blocked it from disclosing clinical data regarding their products.

At a meeting, AbbVie’s Neal Parker said details of adverse drug reactions could be “commercially confidential”.

Broadly, he argued, information on “tactical decisions on how we are going to run a study, engage with regulators, and confront and solve problems and challenges we have uncovered during clinical trials” might be of advantage to competitors.

Aginus Kalis, head of the Dutch Medicines Evaluation Board, replied: “Are you aware you are working in the healthcare industry, with patients and human beings?”

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) have published a draft policy on clinical data transparency.

However, doctor and writer Ben Goldacre told the meeting that the draft policy contains “huge loopholes”, most notably the exclusion of all trials conducted before 1 January 2014 deadline – the evidence base for all drugs currently available.

GSK has agreed to publish all clinical trial results, past and future; however, the industry as a whole has not followed this lead.