Clinical research is fast becoming an everyday part of our NHS, and an everyday part of the patient journey. The aim is, of course, to improve existing treatments and develop new ones, thus improving healthcare and allowing patients to benefit earlier
from innovative treatments they would not otherwise have had access to.
While virtually all NHS trusts in England now have some patients involved in research studies – reflecting the increasing importance of clinical research for the NHS – our researchers have been particularly vocal about the bureaucracy and complexities surrounding the launch and the conduct of these studies. I have been told repeatedly by colleagues from across England of the need for a simplification of these processes, as a necessary requirement to unleash the NHS’ great research potential.
Many of the difficulties we face originate from Brussels: it’s European legislation that regulates the authorisation and conduct of clinical trials – studies involving the development of new medicines or looking into new treatments with medicines that have already been authorised.
Since its introduction ten years ago, the EU Clinical Trials Directive has, in the European Commission’s own words, contributed to a significant fall in the number of clinical trials conducted across Europe, with the time taken to launch new trials increasing by 90 per cent, and the administrative burden also growing significantly.
But there is good news: the time for change has finally come!
The extensive lobbying in Brussels – by the NHS European Office
and other medical research groups – calling for the EU rules to be rewritten has, eventually, paid off. After extensive debates and negotiations at EU level, a new EU regulation on clinical trials entered into force in June 2014, bringing with it a number of positive changes.
Addressing many of the shortcomings of the Clinical Trials Directive, the new EU regulation will:
- Streamline the procedures for assessing and authorising clinical trials, removing duplication and reducing delays in launching new clinical studies.
- Introduce a lighter regulatory regime for trials conducted with medicines that are already authorised and which pose only minimal risk compared to normal clinical practice. This is a particularly significant change from an NHS perspective, as many of the trials led by NHS hospitals study the efficacy of medicines that are already authorised.
- Simplify reporting requirements, sparing researchers from submitting largely identical information on the conduct of the study to various bodies.
- Improve transparency, by requiring the publication clinical trial results, whether positive or negative, so that both researchers and patients can be made aware of past trials and their outcomes, and avoid the same studies being repeated unnecessarily.
- Recognise that a trial can be led by more than one organisation, by formally introducing the concept of co-sponsorship – this is of great importance for many NHS hospitals that have put in place co-sponsorship arrangements with academic partners.
It’s important to note that the new EU law takes the form of a regulation. This means the rules apply directly in each member state, ensuring a level of consistency that has been severely lacking over the past decade.
As an example of the practical impact of these positive changes, it will soon be possible to launch a clinical trial with patients in several different countries through the submission of a single application dossier, instead of having to apply separately in each of the countries involved. This is a significant change and will certainly speed up the time for launching multi-country clinical trials, such as those looking into treatments for rare diseases which, by their very nature, require the participation of patients from several different countries.
The NHS European Office lobbied hard in favour of more proportionate and sensible EU rules that fully protect participants in clinical trials without hindering research in the NHS.
We welcome this new EU regulation and look forward to a speedy development of the EU infrastructure that will support its implementation, so that these positive changes can be applied without delay.
Elisabetta Zanon is director of the NHS European Office. Follow the organisation on Twitter @NHSConfed_EU