A new European Union Clinical Trials Regulation is lined up to replace 14-year-old Directive 2001/20/EC. In this blog post, I’ll outline some of the changes and discuss how Regulation EU No. 536/2014 might affect translators. In my next post, I’ll take a look at some terminology changes, explain how to align the Regulation in any European language pair and share my Spanish-English tmx alignment.
Clinical trials in Europe: the figures 1
- Some 4400 clinical trial (CT) applications are submitted every year in the EU.
- Only 24% of CTs are multinational, but they account for 67% of all trial subjects.
- Clinical trial applications fell by 25% from 2007 to 2011.
- Staffing needs for CTs have more than doubled since 2001 (when the EU Directive came into effect).
- For non-commercial sponsors (40% of clinical trials), administrative costs have almost doubled since 2001.
From Directive to Regulation
In view of declining clinical trial numbers and rising CT costs, the European Commission has decided to change the legislation governing CTs. Member States will no longer implement the Directive in their national legislation; instead, an EU Regulation will automatically apply to all interventional trials in Europe.
The Regulation was adopted in April 2014, but it will probably not come into effect until the end of 2017,2 when the new associated EU Portal and EU Database (see below) have been up and running for six months.
What will the Regulation bring?
Streamlined application process: there will be a single application dossier (instead of one dossier per Member State) and a single online portal for submitting applications.
Simplified review process: for Part I (review of general regulatory compliance, anticipated benefits, risks for subjects, etc.), the trial sponsor will propose one reporting Member State to act as the spokesperson for all Member States concerned (Member States where the CT is to be conducted). Part II will cover compliance at a national level for matters such as informed consent, recruitment arrangements, sample processing and compensation for subjects. A single decision will be issued. Under certain circumstances, a Member State may opt out if it disagrees with the decision.
Faster time to trial start: Instead of the current average time of 152 days, approval could take just 60 days for straightforward trials under the new Regulation.
Increased transparency: The EMA will set up an EU database with information relevant to each trial, including the trial protocol, start and end dates, and results – regardless of the trial outcome – in a lay-friendly summary.
New clinical trial category: low-intervention clinical trial. In 2012, the OECD defined three risk categories for clinical trials, according to the marketing authorisation status of the investigational medicinal product (IMP).3 The new EU Regulation will consider risk categories A and B(1) as low-intervention clinical trials, because they pose only a minimal additional risk to subject safety compared to normal clinical practice. As such, they will have less stringent rules for monitoring, master file contents and IMP traceability.
This has been a very brief summary of the changes that the new Regulation will bring. For more details, I recommend an Xtalks webinar recorded last July by Dr. Martine Dehlinger-Kremer, Global VP, Medical and Regulatory Affairs, SynteractHCR.
Implications for translators
The new Regulation makes almost no reference to specific translation requirements and so, in theory, our workload will not be affected by these changes.
Language requirements are mentioned three times in the new Regulation:
1. Article 26
The language of the application dossier, or parts thereof, shall be determined by the Member State concerned.
Member States, in applying the first paragraph, shall consider accepting, for the documentation not addressed to the subject, a commonly understood language in the medical field.
Since English is the most commonly understood language in the medical field, I think it is likely that the application process will be conducted in English, with translation into the languages used by the Member States concerned. Considerations put forward by those Member States are likely, in my opinion, to require translation into English. I look forward to readers’ thoughts on this in the comments below. What is a commonly understood language in the medical field for you? French? German?
Of course, translation requirements of clinical trial documentation itself remain unchanged. The CT protocol, Investigator’s Brochure and Informed Consent will still need translation and back translation, where appropriate.
2. Article 69
The language of the information on the label shall be determined by the Member State concerned. The medicinal product may be labelled in several languages.
Language requirements for IMP labelling remain unchanged from Directive 2001/20/EC.
3. Article 81
The user interface of the EU database shall be available in all official languages of the Union.
Also, according to the EMA Functional Specifications of the EU Portal and EU Database, issued in March 2015,4 the portal interface is to be in English initially at the time of the audit with the technical capability for the user interface to be displayed in the official EU languages when the system is launched.
Translation of the Portal and Database interfaces will be a one-off need and presumably will be undertaken by the CdT (EU Translation Centre).
This brings me to the end of this brief analysis of the new Clinical Trials Regulation and its implications for translators. In my next blog article, I’ll look at some major and minor changes in terminology definitions in English and some of the translation decisions made in the Spanish version of the Regulation. Plus, as mentioned above, I’ll walk you through a source/target alignment to create a reference translation memory in TMX format. Stay posted!