The proposal for a revamped Clinicial Trials Regulation aims to reduce costly and time-consuming administrative barriers in order to create a more favourable European environment for conducting clinical trials and academic research, while simultaneously protecting high levels of patient safety.

In the updated EPHA Position on clinical trials, we welcome the Commission’s commitment to render the regulatory framework less burdensome, e.g. by simplifying, centralising and harmonising certain aspects of the application procedure and introduction of a single European electronic submission portal. These measures should facilitate multi-country clinical trials, prevent duplication of work, and cut down on administrative requirements and costs.

At the same time though, the new rules and ambitious timelines must not work to undermine the health of individuals. EPHA would like to re-emphasise that the approach must be a patient centred one, meaning that at all stages the best outcome for the safety of the trial subject(s), as well as for the health of medicines users and future patients should be considered.

From this perspective it is also vital that clinical trials reflect the populations that are meant to benefit from them - for example women, older people and ethnic minorities - and that access to clinical trial data and reports is as open and transparent as possible, which implies full public disclosure in a central database to protect public health interests. Moreover, patients’ involvement in the process is essential; while this is foreseen in the present proposal, the extent to which patients will be able to influence the process still requires clarification.

That said, while it is key for patient safety that clinical trials are administered in a thorough and precise fashion, and that patients fully understand the potential benefits and consequences of taking part in clinical research, the administrative and reporting requirements attached to them must not overburden the researchers who set up and run the trials: their successful development and execution is vital in order for patients to benefit from better treatments in a timely way. Moreover, it is important that such requirements are unequivocal to avoid confusion and uncertainty that would be detrimental to patient recruitment and the research process. EPHA also welcomes the introduction of the co-sponsorship concept which should work to enable research partnerships, e.g. between universities and hospitals.

EPHA will be following the progress of the Clinical Trials Regulation in the hope that its revised Position will contribute to relevant debates.

- EPHA Position on the Clinical Trials Regulation,

For further information:

- European Commission, DG Health & Consumer Policy - Clinical Trials
- Health Action International - Europe
- Cancer Research UK


EPHA related articles:

- European Commission revamping clinical trials directive - EPHA responds
- Clinical Trials Register goes live
- Clinical Trials Directive: A barrier to research and innovation in Europe?
- Dalli calls for meeting patients’ needs in revision of Clinical Trials Directive

Last modified on January 30 2014.