By Glenis Willmott - 28th March 2013
A new EU database will be set up to record all trials carried out in the EU, which will be a fantastic step forward
The full results of all clinical trials carried out in the EU must be published if Europe is to remain an attractive place for medical research, argues Glenis Willmott
Everybody agrees that the legislation on clinical trials must change. Many have criticised the current clinical trials directive, saying it is partially to blame for the drop in clinical trials over recent years. Between 2007 and 2011, the number of clinical trials in Europe dropped by 25 per cent.
Of course that is not to say that we do not need European legislation on clinical trials. Without harmonised rules across the EU it is very difficult to conduct cross-border trials. And EU legislation has set minimum standards for patient safety across Europe. Unfortunately many requirements were made with large pharmaceutical companies in mind, overlooking those trials carried out by non-commercial sponsors. Most importantly the directive was implemented differently across the EU, resulting in a patchwork of laws, which are extremely difficult for researchers to navigate. Cross-border trials needed to be authorised in each member state, each using slightly different rules. Research into rare diseases is suffering, which, due to small patient populations, has to be done in a number of countries. For these trials the administrative costs can be prohibitive.
The commission’s proposal for a clinical trials regulation has generally been welcomed by stakeholders. The fact that the legislation will be a regulation rather than a directive will leave no room for differences in implementation. An even bigger step will be the single EU portal, where all clinical trial applications will be sent, regardless of where in the EU they are conducted, and in how many member states. National authorities will work together on the scientific assessment of multistate trials, with one member state taking the lead. These assessments should be completed within strict timelines. Simplifying trial applications in this way will once again make Europe an attractive and competitive place for medical research.
We must also take a more risk-based approach to trials. At the moment a medical research charity looking at the effects of vitamin D and a pharmaceutical company testing a new experimental drug must fulfil similar requirements. To deal with this the new definition of ‘low intervention’ trials will be introduced. If a trial uses a well-known drug and doesn’t include any risky interventions, the researchers will have fewer obligations and less paperwork to fill out, and the trials will be authorised faster.
A more controversial issue will be the idea of national indemnification systems. Since the directive came into force some clinical trial insurance costs have risen by 800 per cent. The fees greatly outweigh the claims. Some member states, such as Denmark, already have indemnity schemes in place. This means the state can insure the trial. I want these schemes to be available in every EU country, free of charge for academic sponsors. I know it will be difficult to convince governments to agree to this. However, when you consider that public money on medical research is being spent on extremely expensive insurance cover, it makes sense.
All of these measures should make the work of researchers easier, whether they are developing a drug for a pharmaceutical company, or conducting academic research. In return I want to see more responsibility from researchers in terms of reporting their results. Transparency in clinical trials is in the interests of public trust in medicine and good science. The results of around half of all trials are never made known, and the majority of those are unsuccessful trials. A trial can be carried out repeatedly before it becomes clear that it is ineffective, or even dangerous.
A new EU database will be set up to record all trials carried out in the EU, which will be a fantastic step forward. However, the commission wants just a summary of the results to be made public on the database. I do not think this goes far enough, as summaries can be biased and misleading, and we need to see fuller results to allow for systematic reviews. In my report I proposed that full clinical study reports are published on the database, and I will be holding an event on April 10 to get some more views on the feasibility of this for non-commercial sponsors.
There are over 700 amendments for us to consider in the environment, public health and food safety committee. We are hoping to reach an agreement with the council before 2014. It is crucial that we get some better legislation in place soon to enable and encourage life-saving research.
Glenis Willmott is parliament's rapporteur on clinical trials on medicinal products for human use