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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Guidance
Update on personalised medicines: Predictive biomarkers
By Libby Amos-Stone & Ian Dodds-Smith on
We have previously reported on the European Medicine Agency’s (EMA) increased focus on the area of personalised medicines. The original blog post can be found here.
The EMA and the Committee for Medicinal Products for Human Use (CHMP) has now released for consultation a concept paper on predictive biomarker-based assay development in the context of drug development and lifecycle. The use of predictive biomarkers is an aspect of personalised medicine used to decide treatment or dose selection.Continue Reading Update on personalised medicines: Predictive biomarkers
Innovative approaches to paediatric drug development
By Jackie Mulryne & Libby Amos-Stone on
On 6 July 2017, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced a joint proposal to promote the use of innovative approaches to paediatric drug development. The proposal focuses on paediatric Gaucher disease, but the intention is for the principles underlying the so-called “strategic collaborative approach” to be extended to other areas of development for rare paediatric diseases.
The collaborative approach was considered necessary as, given the limited number of patients with Gaucher disease, identifying multiple candidate target products, and running multiple clinical trials, may actually hinder the development of an effective treatment.
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