clinical trial transparency

With shocking new findings revealing that around half of all clinical trial results in Europe go unreported, Matt Fellows explores the roots of this not-so-surprising revelation, what can be done, and why it all is so important.

Transparency is one of those words for which the exact meaning has become clouded by murkier connotations. The chances are that if most people were asked to associate the word with an event, it’s more than likely that the example would be negative, whether it be a lack of government transparency, an example of a tech firm refusing to be clear on its data use, or a company not being completely honest about its wrongdoing.

Amid the global political and economic turmoil taking place, one small pharma story got much less attention than it should have.

Not for the first time, the ombudsman for the European Union, Emily O’Reilly, issued a statement calling on the European Medicines Agency (EMA) and AbbVie to cease the withholding of trial data for blockbuster drug, Humira (adalimumab). The company took the EMA to court in 2013 to prevent the publication of data, but reached a compromise, of sorts, whereby redacted documents could be released.

Credit: alphaspirit - Fotolia.com

Even in an industry as litigious as pharma can sometimes be, the recent legal drama that has played out in the High Court has been unprecedented.

And in an industry used to changes in guidelines and demands from watchdogs, it’s unusual for a company to take a regulator to court, and publically accuse it of acting unlawfully in introducing new obligations for firms in the industry to adhere to.

During the time I worked as research, medical and innovation director at the ABPI, between October 2012 and January 2015, there were dramatic changes in the way in which clinical trial transparency was being discussed throughout the R&D ecosystem, resulting in long-awaited improvements.

Thankfully, this time, there will be no turning back.

Trade bodies and transparency campaigners say work on transparency must not be reversed

The Ethical Medicines Industry Group and Sense About Science - a co-founder of the ALLTrials campaign - have written a joint letter, in support of the Health Research Authority's work to bring about greater transparency in clinical trials to the industry. 

In a statement, the two bodies say the recent Court has shown "that there are people who want to reverse its recent attempts to do so."

There is a danger that politicians and others will see this backward-looking view as significant and representative of industry. It isn’t.