BY DANIELA RUGHETTI AND STEPHANE MILLET
Translation of clinical trial submissions and follow-up responses to requests for information cannot be left to chance now that regulatory processes have been streamlined and timescales tightened. Advanced planning is essential to maintain quality and ensure patient engagement and safety.
As of Jan. 31, 2023, all new life sciences clinical studies conducted by or for organizations with sites in one or more EU countries must be submitted under the new EU Clinical Trials Regulation (EU-CTR) using the European Medicines Agency (EMA)’s new, centralized Clinical Trials Information System (CTIS). The new platform and portal are designed to streamline the submission, assessment, and approval of clinical trials across multiple EU markets.
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This streamlining offers many benefits to stakeholders on all sides. But it also presents new regulatory process challenges. That’s because sponsor/clinical research organizations (CROs) with operations spanning multiple markets are required to bring together all of their submissions-based content in a concentrated, consolidated way and satisfy any follow-up queries (requests for information or RFIs) within a short time window — of just 12 days (all in).
Too often, factoring translation/language expertise is left too late. That now needs to change if the overarching goal of clinical trials transformation is to be assured — expediting and democratizing patient access to important drugs, therapies, and vaccines.
Whereas translations and wider language services were previously accessed on a more ad-hoc basis for submission country by country, the emphasis now is on consolidating everything and channeling it through one reporting EU Member State. Once all of the materials have been collated, the work is then typically fed to a designated language service provider (LSP) on the assumption that the necessary resources and experts will be available to process what can amount to a significant batch of work requiring a fast turnaround.
With so many considerations, it’s important that life sciences companies stay ahead of EU-CTR demands. That means having in place optimized processes and maintaining ongoing dialog with providers of language services. This ensures that content throughput and associated deadlines can be anticipated and planned far in advance. Foresight and forward planning will uphold the highest levels of quality — which are crucial for patient safety and engagement — while keeping pace with tight timelines.
Given that regulatory requirements are evolving all the time, having access to focused expertise is important, too, which is a further reason to be mindful and communicative about what is coming up. There may be a specific call for language service experts who understand document redaction requirements, for instance, to protect patient identities and commercially confidential information. Or there may be an upcoming requirement around the specifics of informed consent requirements or plain language summaries. For marketing-type materials used for patient recruitment and engagement, the skills needed are likely to be different again — geared more to hitting the right tone and level of empathy with the required content, as well as all-important message clarity.
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When it comes down to it, getting all of this right — ensuring that content is spot on for the target audience — is as crucial as all other aspects of patient centricity in clinical trial planning.
In other words, the goal and challenge are not only to ensure the accurate translation of medical information when preparing content for each market but also to convey it in a patient-friendly manner.
In this light, plain language summaries (PLS), or “lay” language summaries, have been introduced as a novelty in the new regulation that repeals the Clinical Trials Directive of the EU. Even though the concept is not new to the industry, it has certainly gained importance as making health and science communications intelligible to a broader audience is placed front and center of this new regulation.
This is largely due to the ethical considerations that need to be addressed when talking of clinical trials, as securing informed consent by clinical trial participants is paramount to driving ethical trials where participants learn not only how the trial operates but also the potential risks and expected outcomes.
Mirroring this greater emphasis on providing understandable information for lay audiences and fostering transparency at every stage of the trials is the guidance note co-created and endorsed by the European Commission to help organizations implement key capabilities to write and share PLS. This, too, speaks to the pivotal role of language and context-based information in clinical trial submissions in the EU.
At a high level, there is a need to close the communication gap between clinical researchers and patients, ultimately contributing to more informed and empowered participants in clinical trials.
A consolidated submission process for clinical trials that may involve multiple European countries also adds further complexity to language requirements as sponsoring entities have to provide translations of study documents for each country involved, and the regulatory and ethics review process may differ from one country to another. This further emphasizes the need for careful language planning and coordination regarding clinical trial submissions.
With consolidated and centralized submissions, many administrative hurdles have been eliminated. Still, other factors have grown in importance and demand a more robust approach: Language planning under the new consolidated clinical trial submission process has become a priority for many organizations. It should remain important in securing the accessibility of information and regulatory compliance at all stages of clinical trials.
Daniela Rughetti is a strategic account manager for Acolad Life Sciences, committed to delivering quality language services to the largest healthcare brands around the globe.
Stephane Millet is the director for strategic accounts of Acolad Life Sciences, dedicated to providing cutting-edge clinical and patient engagement solutions that cater to the informational needs of patients globally.
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