The New Clinical Trial Regulation
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On 16 April 2014 the new Regulation EU No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC was adopted, and published in the Official Journal on 27 May 2014 (the "Clinical Trials Regulation").
The Clinical Trials Regulation aims to create an environment that is favourable for conducting clinical trials, with the highest standards of patient safety, for all EU Member States. Intrinsic to this is the simplification of current rules, for example:
- A streamlined application procedure via a single entry point - an EU portal and database, for all clinical trials conducted in Europe. Registration via the portal will be a prerequisite for the assessment of any application;
- A single authorisation procedure for all clinical trials, allowing a faster and thorough assessment of an application by all Member States concerned, and ensuring one single assessment outcome and authorisation per Member State;
- The extension of the tacit agreement principle to the whole authorisation process which will give sponsors and researchers, in particular SMEs and academics, more legal certainty;
- Strengthened transparency for clinical trials data.
Ethics committees will be involved in the assessment of clinical trials application. However, as with the current situation, their responsibilities and detailed composition will be determined independently by each EU country. In this way the different traditions in the various Member States are respected.
The Regulation, while continuing to uphold patient safety, takes better account of the actual risk to which subjects will be exposed during the clinical trial and adapts the regulatory burden in relation to the risk posed. It introduces the concept of a 'low-intervention clinical trial' - an example being clinical trials comparing already authorized medicines. In such cases, the regulatory requirements will be lighter.
The Regulation extends the concept of tacit agreement to avoid bottlenecks and delays in the procedure. This is to alleviate an unnecessary and frustrating restriction that trial sponsors face under the current rules. It is important, however, to emphasize that Member States will always have the possibility to stop any clinical trial, which they consider could endanger the heath of the participants.
Transparency on the conduct and results of clinical trials has several benefits, and the Regulation strengthens the rules accordingly. Transparency avoids redundancy and duplication. It ensures that even clinical trials with unfavorable results are made public, thereby avoiding 'publication bias'. Finally, transparency gives patients the possibility to find out about on-going clinical trials in which they may wish to participate.
The Regulation will ensure that, no matter where a clinical trial is being performed, the fundamental rules for the protection of subjects are applied. It therefore includes rules for clinical trials which are conducted outside the EU but referred to in a clinical trial application within the EU. For such trials, the rules call for compliance with regulatory requirements at least equivalent to those in the EU, including rules on transparency.
Why should you Attend:
It is important to know the new procedures for approval of clinical trials to avoid delays and minimize the time for approval. Especially the procedure for assessment and approval of multinational clinical trial authorisation applications will change. A single authorisation procedure for clinical trials will be introduced that will be performed electronically via a new EU portal
In the current situation, a common protocol is proposed in all EU Member States that participate in a clinical trial but requests for amendments may result in country-specific changes that require subsequent amendments in other countries to maintain a common protocol. In the Webinar it will be explained how in the new procedure this problem will be avoided.
A detailed knowledge of the new procedure are all key to personal responsible for clinical trial applications.
Additionally, the new Regulation will affect how the conduct of a clinical trial is managed after approval has been granted. New provisions for public access to an EU clinical trials database will enforce disclosure of clinical trials data and information.
The new Regulation will change the way pharmaceutical companies handle the clinical trial approval process, and companies need to start preparing for these changes now. The timelines for implementation will be discussed in this Webinar to allow optimal preparation.
Areas Covered in the Session:
Who Will Benefit:
- Disadvantages of the current situation
- Overview of the Clinical Trials Regulation
- Scope of the Regulation
- Low intervention clinical trials
- EU portal and database
- Authorisation Procedure
- Regulatory Affairs personnel
- Clinical Operations personnel