An injection of sense
Proposals to change the EU clinical trials directive could benefit NHS involvement in clinical research, writes Elisabetta Zanon.
The number of clinical trials conducted in the UK has significantly dropped since the introduction of the EU clinical trials directive in 2004.
However, there has been a blaze of positive publicity surrounding clinical research in the NHS recently. We have had league tables showing those trusts most heavily engaged in research, success stories highlighting how organisations of all sizes have increased the number of patients enrolled in studies, and examples of how trusts have increased their income through this route.
These developments, as well as figures showing that 99 per cent of NHS trusts in England had some patients involved in research studies last year, clearly demonstrate that clinical research is becoming increasingly important for the NHS.
Clinical studies involving NHS patients often take the form of clinical trials, which are studies aimed at testing the safety and efficacy of medicines. They are an essential part of the development of new medicines, and also have a role in the improvement of medical care more generally. They allow us to compare treatments and improve the use of medicines which are already authorised. As such, trials are a key element of NHS research, allowing participating trusts to provide innovative treatments and higher quality healthcare.
‘The revised legislation is a clear attempt to speed up the authorisation of new clinical trials’
The process surrounding the approval and the conduct of clinical trials in the UK is governed by EU legislation. The European clinical trials directive aimed to harmonise processes for the conduct of clinical trials across the EU, while ensuring the protection of the health and safety of clinical trials’ participants, the ethical soundness of the trials, and the reliability and robustness of data generated.
Despite these laudable objectives, the directive has contributed to a 25 per cent fall in the number of clinical trials conducted across the EU between 2007 and 2011, with the time taken to launch new trials increasing by 90 per cent and the administrative burden also growing significantly, according to the European Commission’s own figures.
These unintended consequences, mainly due to the diverse interpretation of the EU regulatory framework by different European countries, have restricted innovation and reduced the competitiveness of clinical research in the UK, and the EU more generally, with knock-on effects on patients’ access to new medicines and treatments.
European institutions have acknowledged the difficulties generated by the directive. After an extensive consultation of stakeholders on how the EU law could be improved, the European Commission released legal proposals to amend the existing directive last summer.
Most importantly, the revised legislation now takes the form of a regulation, requiring a one size fits all approach from all countries. Once agreed, the legislation will apply directly in each EU member state, ensuring that the rules for conducting clinical trials will be more consistent across Europe.
The revised legislation represents a substantial change from the current regulatory framework. It is a clear attempt to streamline the existing rules in order to reduce the administrative burden and speed up time for the authorisation of new clinical trials.
The NHS Confederation’s European Office, which represents NHS organisations to the European Institutions, has been pressing for changes to the existing directive for a number of years and is pleased to see that the EU proposals reflect a number of amendments we have called for on behalf of the NHS.
The first significant amendment concerns the application and authorisation process before a clinical trial can start. Current rules require the submission of separate application dossiers for each of the countries involved in a trial, often resulting in a disproportionate administrative burden and delays in the launch of clinical trials.
What is proposed in the new EU regulation is a single application dossier to be submitted via an “EU portal”. While all countries in which the sponsor intends to conduct the trial will be involved in the assessment of the application, they will have to cooperate in several areas of the process with one member state leading and coordinating on their behalf. These changes should reduce the bureaucratic burden, speed up the authorisation process and reduce the lengthy delays that have hindered many clinical trials applications.
Another positive proposal is the recognition that trials which pose no or very limited additional risk to participants compared with normal clinical practice should be subject to a lighter regulatory regime. The proposed regulation identifies a new category of clinical trials, called “low interventional”, which are subject to more proportionate rules around different aspects of the clinical trial process, including timelines for authorisation, monitoring, reporting, and insurance requirements.
This is a positive step forward for NHS organisations. It is in line with domestic efforts to develop a risk-proportionate regulation in clinical trials and responds to a major criticism that the current directive has placed the same onerous burdens on clinical trials irrespective of their level of risk.
The explicit introduction of the concept of co-sponsorship in the new regulation is also a very positive development from an NHS perspective. Unlike the vast majority of other EU countries, the UK interprets the current directive as allowing trials to be sponsored by more than one organisation, meaning the responsibilities for initiating and managing a trial may be shared.
NHS trusts use this model widely, often leading clinical trials jointly with their partner universities, and so maintaining the flexibility of having trials sponsored by more than one organisation was of great importance for the NHS.
The new EU regulation seeks to simplify the insurance compliance requirements for clinical trials. Current requirements have substantially increased the costs and burden of conducting trials and have created difficulties for NHS trusts sponsoring multinational trials in terms of their ability to get insurance cover for clinical trials sites outside the UK.
The new proposal attempts to tackle this by exempting from these requirements those trials that pose only negligible additional risk compared with treatment in normal clinical practice.
More controversially, it proposes that each member state sets up a national indemnification mechanism working on a not-for-profit basis to help non-commercial sponsors comply with insurance requirements.
In terms of next steps, the proposed regulation will now pass through the EU legislative procedure, with negotiations in Brussels expected to last for several months and during which we will continue to press for NHS views to be heard by EU decision makers.
The reform of the EU clinical trials directive was long overdue and after extensive efforts by many health and research bodies, including the NHS, it is encouraging to see that the European Commission has listened to many of our concerns and proposed a way forward.
An improved and streamlined EU regulatory framework for clinical trials is essential for the NHS in light of the increasing importance of clinical research and innovation for the health service.
We are committed to making the most of this opportunity and to ensuring that the new EU law is fit for purpose in terms of maintaining patient safety while promoting high-quality research in the NHS.
Elisabetta Zanon is director of the NHS Confederation’s European Office.