Impacts of New EU Clinical Trials Regulation Framework on Translation

The impending EU Clinical Trials Regulation (Regulation EU No 536/2014)—commonly referred to as CTR—is set to make significant changes to the way clinical trial applications are managed in Europe once implemented in 2019. While the CTR is sure to bring added transparency, harmonization, and modernization to clinical operations, the regulation also presents specific challenges, some of which will have a significant impact on both the documentation and the translation process. Delivering a high-quality translation is imperative at the core of the process. With a focus on workflow, proactive planning, and a capable partner, these challenges can be averted while maintaining—if not improving—quality of final documents.

1. Develop a successful process for authoring and translating Plain Language Summaries (PLS).

   One of the most notable new requirements in the CTR is the need to publish a summary of every clinical trial conducted in the EU within one year of trial completion. Intended for laypersons, these are referred to as Plain Language Summaries (PLS) or lay summaries. The PLS should be provided in the official language of the country/ies in which the study was conducted. Some companies opt to translate into additional languages for the EU or ROW, but this is not technically required.

   In order to maximize the efficiency of this workflow and final quality of the PLS, it is important to author the documents at a translation-friendly, sixth grade reading level—with concise language, clear sentence structure, consistent vocabulary/syntax, and clean formatting. When moving on to the translation process, it is important to consider a number of factors. Should back-translations be performed? Will there be an in-country review by your affiliates of the translation? Will they review the translation or back-translation? In what format should final deliverables be provided? Depending on the answers to these questions, the workflow can become somewhat complex, but can be controlled by selecting a partner that can manage the process from start to finish in a transparent method, streamlined through technology.

2. Create an efficient workflow to deliver all core national documents for the initial assessment.

   While the regulation asserts that Member States have the authority to establish language requirements for the application dossier, companies should plan, at a minimum, to submit documents intended for subjects in local languages during the initial assessment phase. Previously, sponsors and CROs had some freedom to proceed with the customization and translation of Informed Consent Forms, for example, at different rates depending on approval and activation timelines on a national level. Under the new model, it will be necessary for all of this to be prepared for one initial deadline, adding timeline pressure across the workstream.

   With a shift from thinking of translation as an afterthought at the end of the process, to looking at the full document authoring and translation workflow, there is opportunity to gain significant efficiencies. Starting with the global English master documents, content management and authoring tools can be used to eliminate redundancies, ensure appropriate reading levels, and make your documents as translation friendly as possible. Then, after country-level customization where applicable, (i.e., for consent forms) the translation process begins. At this stage, working with translators who have extensive experience with clinical documentation and an understanding of the intricacies and differences between patient-facing and investigator-facing materials is critical to ensuring the highest quality output. Use of this end-to-end process results on average in a 30% reduction in translation costs and 50% reduction in overall cycle time.

3. Review your process for IMP label creation and translation.

   The CTR includes a refresh of requirements for immediate and outer packaging of investigational medicinal products (IMP), building on the current standard Annex 13. The efficient preparation of IMP labels is a critical point within study start-up, and delays here can have serious implications on overall study timelines. Unfortunately, IMP labelling can also easily become a bottleneck point if not managed appropriately. One of the reasons for this is that there are often a large number of stakeholders involved in the labelling process—including sponsor, CRO, CMO, and other third-party labelling support vendors. TransPerfect has developed an approach to manage this workflow efficiently across all involved parties—working from initial label creation, to regulatory approval and national label customization, to translation, and finally proof review and approval. For a top-10 global pharmaceutical company, this workflow reduced overall label production timelines from initiation to proof approval and printing by over 60%.

4. Ensure that your safety reporting workflow is up to standard.

   A primary reason for the implementation of the CTR is to ensure the highest standards of patient safety. In line with this goal, the CTR contains significant guidance on the safety reporting process. Timelines are rarely more critical than when facing a tight turnaround with regulatory authorities. Having a translation workflow for SAEs/SUSARs/CIOMS/etc. that runs like a machine helps to reduce risk of late reporting and ease pressure within your safety/PV team. Bottlenecks often arise at handoff points between CRO, sponsor, and translation agency. With a central online tool for managing translations that enables visibility between all parties in the process and agreed-upon translation cycle times of 24–72 hours for urgent reports, these bottlenecks are eliminated, resulting in an efficient workflow guaranteed to meet even the most urgent reporting timelines.

For more information on how TransPerfect can assist with your company’s CTR readiness strategy through consulting, medical writing, e-clinical technology, and language services, please contact regulatory@transperfect.com.