Proceedings from AHPPI’s conference on Risk Management in Early Phase Clinical Trials, 29 Oct 2015 (link).
The new EU Clinical Trials Regulation (EU CTR) is intended to stimulate innovation, research and development in Europe. One of its key aims is to reverse the decrease in the number of clinical trials performed in Europe, by simplifying clinical trial application and authorisation processes. The second key aim is to increase transparency and availability of information on clinical trials and their results.
Phase 1 clinical trials are usually conducted early during a new medicine’s development. At this stage, particular care needs to be taken to find the right balance between protecting commercially confidential information and making relevant information about the trial available to the public.
The presentation described how the AHPPI, as a member of the European Federation for Exploratory Medicines Development (EUFEMED), participated in stakeholder discussions led by the European Medicines Agency (EMA) over the last year. We made proposals on how the transparency requirements of the EU CTR could be suitably implemented for Phase 1 trials, within the framework of the functional specifications of the EU portal and database.
The presentation goes on to describe the outcomes of the stakeholder discussions. In early October 2015 the EMA published the finalised disclosure rules. These rules give a clear definition of what types of trials are defined as “Category 1”, i.e. trials – including Phase 1 – that do not intend to treat, prevent or diagnose a condition. For Category 1 trials the disclosure rules allow adequate time windows for publication of trial information and results that are of sufficient length to protect commercially confidential information and patent rights. Equally, the time windows are appropriate for publication at a time when the information becomes relevant for the public.
Written by Dr Ulrike Lorch Richmond Pharmacology Limited. Ulrike trained as an anaesthetist in London and has more than 15 years’ experience in conducting early phase clinical research as a principal investigator. She is an appraiser for physicians revalidating with the UK’s General Medical Council and a member of the Faculty of Pharmaceutical Medicine’s Board of Examiners and an Educational Supervisor for specialist trainees in Pharmaceutical Medicine. Dr Lorch is the AHPPI Chair-elect.