As the second biggest market in the global clinical trials market, Europe offers a number of distinct benefits when it comes to clinical trials. Not only does the continent provide large private and public incentives for scientific research, but it offers a diverse environment that can boost the study’s credibility and recruitment numbers. By basing a clinical trial in Europe, you also get access to EU based grants and well-equipped sites, all whilst putting your team within social reach of Key Opinion Leaders in a wide range of therapeutic areas.
Oftentimes, however, these benefits are overshadowed by the perception that navigating EU regulation in clinical trials is difficult. This is not true and the reality is that, with a roadmap of key issues in mind, navigating regulatory affairs cro can be easy. In fact, they offer a number of structural advantages.
In this article, we’re going to outline 4 key issues to consider when navigating EU clinical trial regulations.
1. The Regulatory Framework
All trials held in the European Union need to be registered with the European Medicines Agencies. The EMA reviews clinical trial data and currently publishes information about clinical trials and study results in their database — the European Union Drug Regulating Authorities Clinical Trials (EudraCT) database. For this reason, all clinical trials and the people working on them need to attain a EudraCT ID number. This can be a fairly complicated process; to find out how to apply for this ID number, learn more with Dokumeds’ ebook.
2. Upcoming changes
Over the coming months, the EudraCT system is set to be replaced. Under EU Regulation
N° 236/2014, which comes into full effect in December 2021, the EU will implement a web-based unified information management system. Getting to grips with what this involves — from sponsor updates to public information—will be a key issue in upcoming months. These changes are covered in more detail in the Dokumeds ebook.
3. Unified Legal Change
At the same time as this change is implemented, the EU will become united under new legislation. EU Regulation N° 236/2014 lays out guidelines on everything from adverse reactions to information transparency. It also establishes a singular process that will be used to register and approve clinical trials. It is, of course, crucial that anyone involved in clinical trials reads up on this legislation and the impact it might have on trials.
4. Privacy Regulations
Patient privacy rules in the EU are among the strictest in the world. The European Union uses a broad definition of “protected data” and outlines all regulations within GDPR, which can be difficult to interpret. Since failure to comply with GDPR can result in fines of up to 20,000,000 Euros, complete familiarity with these regulations is key.
For information on how to adhere to privacy regulations as well as all the other information, you need for a straightforward path to regulatory approval. Learn more today with Dokumeds’ guide to navigating EU clinical trial regulations.
Author – Janis Brix, CEO Wigwam