EU Clinical Trial Regulation: What Does it Aim to Achieve?
In an interview with Applied Clinical Trials Associate Editor Don Tracy, Xandra Neuberger, associate director, regulatory affairs, PharmaLex, discusses the goals of the EU clinical trial regulation.
ACT: What does the EU’s clinical trial regulation aim to achieve?
Neuberger: That is an important part. Why are we where we are? I think when talking about clinical trial regulation, it is important to remember that we're talking about the framework under which 27 countries agreed to. Until January 2022, we had the old regulatory framework, and that was a clinical trials directive. The nature of the directive is that it needs to be translated into national law. This resulted in 27 local law or legislations, 27 timelines, 27 procedures, at least 27 procedures, member state specific things really diverging quality across the European Union with regards to the clinical trials. That resulted in a lack of oversight in clinical trials. So, it was 27 clinical trials instead of one. That’s why the member states were trying to harmonize clinical trial requirements, timelines, and procedures if you had a multistage trial. That was where we came in with regulation, and this is how we made it to the current regulation.
FDA Outlines Updated Requirement for Placebo-Controlled Trials in Vaccine Research
May 21st 2025In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
