On 20 July 2017, the EMA published the updated guideline on first-in-man (also known as phase I) clinical trials. First-in-man trials often carry the greatest risks, and have been the ones that generate the biggest headlines when they have gone wrong, for example the Phase I trial in France by Bial-Portela & CA SA in 2016. The new guideline, which applies not only to first-in-man trials, but also to all ‘early phase clinical trials’ that generate initial knowledge on tolerability, safety, pharmacokinetics and pharmacodynamics, aims to ensure such trials are conducted as safely as possible, and assists sponsors in the transition from non-clinical to early clinical development.
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Clinical Trials
Consultation on serious breaches of clinical trial protocol
By Arnold & Porter on
Posted in Clinical Trials, EMA
Under the new Clinical Trials Regulation 536/2014/EU, it is now a requirement for the sponsor of a clinical trial to report to the regulatory authorities a serious breach of the Regulation or to the clinical trial protocol (Article 52). A serious breach, in this context, is defined as “a breach likely to affect to a significant degree the safety and rights of a subject or the reliability and robustness of the data generated in the clinical trial“. This requirement is currently contained in the legislation of some Member States, such as in the UK (Regulation 29A Medicines for Human Use (Clinical Trials) Regulations 2004/1031), but was not previously included in Directive 2001/20/EC or in ICH GCP (although a sponsor should list all significant protocol non-compliances in the clinical study report). This is, therefore, the first time that there is such a requirement in all EU countries.
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