Clinical Trials Insight How we got here: EU’s clinical trial regulation had a three-year rollout
CTIS goes live; sponsors can submit trial applications
Jan 2022
One-year grace period: sponsors can apply via CTIS or via established systems
Jan 2022
Apr Jul Oct Jan 2023
Apr Jul Oct Jan 2024
of disclosing commercially confidential information by adopting ‘lean writing’ practices. In other words, writing with care and restraint, especially when content will be made public. This is where AI tools are being put to the test. Powered by large language models and natural language processing, AI can now auto-draft, summarise, translate and simplify complex clinical content with a surprising degree of fluency. Writers are using these tools to rapidly produce first drafts of lay summaries and protocol synopses, then refining them with expert oversight. “We’ve developed and optimised a set of tailored prompts designed specifically for each section of the document. These prompts help generate initial content in plain language, providing a solid starting point for our writers,” Künnemann explains. The result? A process that used to take days now often completes in hours. However, one must proceed with caution. “It is not possible – or advisable – to fully rely on the accuracy of AI-generated content in regulatory medical writing. Every piece of information produced with AI support must be carefully reviewed and validated by a qualified medical writer,” Künnemann notes. Like in many industries concerned with quality output, AI doesn’t replace the writer; it removes the repetitive, mechanical burden – freeing human experts to focus on accuracy, coherence and compliance. A key strength of AI lies in its ability to translate scientific language into something a lay audience can digest – without losing precision. Tools can analyse complex paragraphs and offer suggested rewrites in simpler terms, flagging obscure phrases or overused technical jargon. Many platforms now include models trained specifically on biomedical data, allowing for greater contextual awareness and fewer misinterpretations. These models can even offer graded reading levels, so that lay summaries can be appropriately targeted – something regulators are increasingly encouraging.
Speaking my language
Language diversity in the EU adds another layer of complexity. Regulation 536/2014 requires lay summaries and participant-facing documents to be translated into
www.worldpharmaceuticals.net
Apr Jul Oct Jan 2025
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the official languages of all participating countries in a trial. Here again, we’ve moved beyond Google Translate. Tools like DeepL and domain-specific machine translation engines can generate initial translations rapidly. However, these outputs still require review by local language experts, but the groundwork – once laborious – is now substantially lighter. For medical writers, this is a major time-saver. Transparency also brings risk. With the increase in public-facing documentation comes a heightened need for sensitive data redaction, particularly under GDPR and EMA guidelines. AI tools can assist by identifying personally identifiable information and suggesting anonymisations or redactions. Künnemann cautions, however, that: “It’s essential to confirm that any AI tools used are handling sensitive data appropriately and transparently… A formal agreement outlining the responsible use of AI should be in place and signed by all relevant stakeholders before these tools are incorporated into regulated workflows.”
The European Medicines Agency has stressed the importance of applying critical thinking and proper oversight when using large language models. In short, AI can support, but not replace, human responsibility. Writers must still ensure that all documents comply not just with content guidelines but with ethical and legal standards.
Perhaps the most valuable contribution of AI is the time it gives back to medical writers. By handling initial drafts, managing formatting, auto-filling metadata for CTIS submissions and offering suggestions for simplifying content, AI lets professionals focus their attention where it’s needed most: getting the science right, ensuring compliance, and making sure every document tells the truth clearly and responsibly.
Looking ahead, Künnemann believes this collaboration between humans and machines is only just beginning: “AI has already made its way into medical writing, and it’s clear that it’s here to stay… Gaining hands-on experience will be key to understanding their capabilities, limitations and how best to use them responsibly.” ●
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All new trial applications must be submitted through CTIS
Jan 2023 Source: Clinical Trials Arena
All new and
ongoing trial must go through CTIS
Jan 2025
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