Sometimes researchers who want to test the effectiveness of a simple thing, such as how daily vitamin D supplements help patients with a certain disease, are prohibited from doing so by the sheer cost and administrative demands of setting up a trial. Then there are those who want to test a drug for patients with a rare disease, but can’t find enough patients in the UK to get reliable data.
It’s clear that something needs to be done to address these problems.
Clinical trials legislation comes from the European Union (EU) to ensure that trials are carried out under good safety and quality standards, wherever they are done in the EU. It is also meant to enable cross-border trials to be carried out easily. While parts of the current Clinical Trials Directive are very good, there are two big problems.
Firstly, the demands the directive places on researchers can end up costing a lot of money in insurance and staffing fees, and a lot of time in terms of administration and authorisation delays.
Secondly, the directive has been written into national law differently in each country of the EU. This has resulted in a patchwork of regulation, which makes the cross-border trials, which the directive should facilitate, extremely difficult to manage in practice.
Sadly, these problems have led to a significant decline in the number of clinical trials that take place in the UK and elsewhere in the EU. Between 2007 and 2011, the amount of clinical trials in the EU fell by 25 per cent. In terms of research, we are losing out to emerging markets. And patients are missing out on life-saving medicines.
In response to these criticisms, the European Commission has proposed new legislation, and we are now beginning our work on this in the European Parliament.
I am delighted to have been named ‘rapporteur’, which means I will be the leading MEP on clinical trials, responsible for drafting the Parliament’s report, negotiating with other political groups, and eventually agreeing the final legislation with EU governments. The Commission has given me a decent starting point with its proposal.
Firstly, it has come up with some good ideas for addressing the bureaucratic burden of the current rules. The new concept of a low-interventional trial will mean trials using different doses or indications of well-documented drugs will have less administrative hoops to jump through. And strict deadlines for regulators will mean the time between submitting the application and getting the first patient started on the trial will be greatly reduced.
Secondly, the Commission has made big steps towards making simple cross-border trials a reality. It has proposed a regulation to replace the current directive. This means that, once agreed, the Clinical Trials Regulation will become law directly in all 27 EU countries, leaving no room for differences in regulation. The idea of a single EU portal for all clinical trials has also been proposed, which will mean that researchers will need to prepare just one application, regardless of how many countries the trial will take place in.
While these positive steps forward have been made, there are many areas that I want to work on in my report. Firstly, we have to look at transparency of trial results. If a trial is abandoned early, it is in the public interest that we know why that was. Was it because of safety concerns, was it that the researchers weren’t getting the result they wanted? All of this information is crucial for other researchers looking into the same or similar drugs, or the diseases they treat.
We also need to make sure that information from a trial is not being unfairly withheld under the guise of ‘commercial confidentiality’, especially if it has implications for patient safety.
I am going to need to look carefully at the Commission’s proposals on how a trial is authorised, how cross-border trials are regulated, and the feasibility of having a single EU portal for applications. It may also be necessary to address the issue of ethics committees, and the different roles they play across Europe. At the end of the day, I want to make sure that we reach a balanced piece of legislation that will benefit good research and science, and most importantly, patients.
I am currently consulting with all relevant stakeholders on clinical trials, and would be happy to hear the views of those who work in the field or have an interest in the legislation.
You can read more about the proposal for a new Regulation on EU clinical trials on the NHS European Office website.
Glenis Willmott is a member of the European Parliament (MEP) for the East Midlands region.For more information about Glenis and to let her know your views, please visit her website, follow her on Twitter @GlenisWillmott or view her Facebook page.