Every year 20 May is an auspicious date in the clinical trials calendar because it commemorates the day on which James Lind began his trial comparing treatment for scurvy in 1747. The event is still marked each year by the European Clinical Research Infrastructures Network (ECRIN), an organisation set up to enhance communication and coordination of clinical research between countries and better meet the needs of patients globally.
Much has changed, of course, in the intervening 266 years, and the regulatory landscape is about to undergo another period of upheaval with the publication of a new EU Clinical Trials Regulation aimed at simplifying the bureaucratic red tape surrounding the trials process in Europe and making the data more readily available and the results more transparent.
Certainly there is much to commend these aims. A series of scandals and controversies in recent years involving falsified data, exaggeration of positive results and the playing down of negative outcomes has further tarnished the already none-too-shiny reputation of the pharmaceutical sector, and greater scrutiny of trials data is highly desirable.
But at the same time there is a fine balance to be struck between greater transparency of data and the risk of compromising patient confidentiality. And while making Europe a more attractive location to hold clinical trials, the danger is that things go too far the other way and jealously guarded intellectual property could be jeopardised.
Reaction to the proposals among pharma companies has been mixed. Some, like GSK, have embraced the concept wholeheartedly and are acting ahead of the legislation, while others are much less enthusiastic.
At the end of April the EMA suffered a setback when the General Court of the European Union made an interim ruling that the EMA should not provide documents as part of two access-to-documents requests made as part of court cases brought by AbbVie and InterMune, challenging the Agency’s decision to grant access to non-clinical and clinical information (including clinical-study reports) submitted as part of marketing authorisation applications.
There are many reasons why many drug trials are unsuccessful, not all of them clinical. It must surely be in the interests of all parties – patients, regulators and the research community – to understand what happened to avoid similar outcomes in future.
