The changes are being proposed in part with the European Commission and the Member States of the European Union (EU) and have been outlined in a new concept paper released for public comment.
The concept paper, which was released late last week, was prepared by an expert group with members from across the EU and was implemented by the Committee for Medicinal Products for Human Use (CHMP) – the committee at the EMA that prepares opinions on questions concerning medicines for human use.
According to the EMA, the review also takes into account the lessons learned from the Biotrial first-in-human clinical trial in Rennes, France, in January 2016, during which one volunteer died and others were hospitalized.
The ‘Problem statement’ and discussion
The paper outlines a few specific “discussion points” that were identified as part of the EMA’s review of the current guidelines published in 2007.
According to the paper’s “Problem statement,” the guidelines focus on drug development’s non-clinical aspects and use of animal data, and “reflects the practice at the time it was developed which focused on a single ascending dose (SAD) design for first-in-human (FIH) trials.”
However, since 2007, the integration of non-clinical data that is available before FIH administration has evolved – as has the pharmacokinetic (PK), pharmacodynamics (PD), and human safety data.
“Consequently, the practice has evolved and many FIH trials are now performed with integrated protocols potentially combining a number of different study parts,” according to the paper.
As such, the paper explained that FIH and early phase clinical trials with multiple study parts are being submitted as part of a single clinical trial application.
Due to this increased complexity, the paper proposes that the revised guideline “should continue to be followed in conjunction with all applicable national and international guidance in an integrated, risk-based approach.”
The paper adds, “…although already outlined in the current document, there is a need to emphasise that the guideline is applicable for all molecules and not only for biotechnology-derived proteins.”
The guideline update will be based on the concept paper and feedback received from stakeholders. A draft of the revised guideline is expected to be published before the end of 2016.
Comments on the proposals can be sent to SVUemail@example.com until September 30, 2016.