Consultation on the European Medical Association’s draft policy on the publication and access to trial data ends on 30th September. What will it mean if the policy comes into force in January 2014, as the EMA expects? Will it bring in a new era of openness or make it even harder for pharma companies to protect the fruits of their research investment?
It’s all about trust.
GCP provides the framework for effective and reliable trials – but not all trials are published. This is understandable if there is a breach of best practice that throws the results into doubt – but what if the trial methodology seems flawless?
What if, as some claim, pharma companies only release data that shows their products in the best light, burying those with less clear outcomes?
In 2009, the world was in the grip of the Swine Flu epidemic. Keen to protect their citizens, the UK and Australian governments commissioned work to update a report on the efficacy of Roche’s antiviral, Tamiflu. They chose the Cochrane Group to oversee the work – after all, they had published a review of Tamiflu’s effectiveness a few years before.
To put things in perspective, in 2009, Tamiflu, had sales of £2 billion – 60% of which came from governments stockpiling the drug to protect against swine flu.
What should have been a straightforward update became complicated when questions began to be asked about one of the main studies referenced by the original review.
The “Kaiser” study pooled the results of 10 clinical trials but the results of only two of those trials had been fully published in medical journals. With the data from eight trials missing, how could the researchers be sure of their original conclusions that Tamiflu reduced risk of complications from flu?
Since the researchers would not sign Roche’s confidentiality agreement, the company did not release the remaining data. Without more complete data, the Cochrane group decided not to include the Kaiser study in its review and concluded that Tamiflu could not be shown to reduce the complications of influenza.
This prompted a change in policy at the BMJ (British Medical Journal), who will now only publish results of drug trials if the sponsor agrees to provide data on request.
Since then, Roche has agreed to supply the Cochrane Group with clinical study reports for all Roche-sponsored Tamiflu trials. It also commissioned researchers at the Harvard School of Public Health to re-analyse the Tamiflu clinical data, and they largely confirmed the company’s previous positive conclusions.
So has this ushered in a new era of openness?
GlaxoSmithKline has announced its intention to share data from all global clinical trials dating back to 2000 - over 1,000 trials. In February of this year, Roche said that it would be releasing detailed clinical data to outside researchers who request it.
The EMA’s policy can be seen as the next logical step and has been supported by both GSK and Roche. However, support is far from universal. The Pharmaceutical Research and Manufacturers of America group believes it goes too far. The industry body maintains that the policy is tantamount to passing competitors the results of billions of dollars of research. Some also believe that the policy could dissuade companies from investing in European research.
US federal laws restrict what types of information can be released in the country, particularly personal or commercially confidential information. However, understandably, the FDA is closely monitoring developments in Europe.
There are still two things that could affect the implementation of the EMA’s trial data policy – on-going legal challenges seeking to clarify the concept of commercially confidential information, and the impending overhaul of the EU’s clinical trials directive (which includes the proposal that, “in general the data included in clinical-trial study reports should not be considered commercially confidential once a marketing authorisation has been granted or the decision-making process on an application for marketing authorisation has been completed”). But it looks like years of suspicion around selective publication of trials data could soon be a thing of the past – in Europe at least…
Will European research suffer from such enforced openness or does the pharma sector stand to gain from the trust gained from such a “warts and all” approach?
I’d love to know what you think!
Blog Author: Dr. G.C. Practice
Whitehall Training provides online training courses developed to meet the learning needs of both the clinical and pharmaceutical sectors. Clients range from clinical research doctors and nurses to international Pharma companies and CROs.
Students develop their skills and earn CPD points with industry-recognised compliance training. Trainers and administrators save time by assigning and managing licences with our easy-to-use admin system.
To date we have trained over 21,000 students across 40 plus countries.
