Imagine standing at the crossroads of hope and uncertainty, armed with a diagnosis but left in the dark by a wall of complex medical jargon. A grandmother with a rare condition, eager to understand her options; a young parent, desperate for answers to help their child. For them, clinical research holds the promise of life-changing treatments—but the language of that research often feels like a foreign code.
Consider this: “The investigational drug demonstrated a statistically significant improvement in primary endpoint measures of progression-free survival (PFS) and overall response rate (ORR) compared to the placebo group, as evidenced by a hazard ratio (HR) of 0.65 (95% CI: 0.50-0.85, p<0.001)”.
To many, it sounds like a riddle wrapped in statistics. Yet, what if that same finding were translated into something simpler and clearer? “The experimental drug showed a clear improvement in how long patients lived without their disease worsening and in how well they responded to treatment compared to those who received a placebo. The results indicated a 35% lower risk, which is highly unlikely to be due to chance.”
Plain Language Summaries (PLS) do exactly that —cut through the complexity and speak directly to those who need it most. They transform vital discoveries into accessible insights, turning data into understanding, and, ultimately, into empowerment. For patients and families, PLS are becoming a beacon of clarity in a world where every word matters.
the impact of the EU-CTR
The introduction of the European Union’s new Clinical Trials Regulation (CTR) has transformed how Plain Language Summaries (PLS) are implemented and standardized across the industry. By mandating that trial results be accessible and comprehensible to the public, the CTR aims to enhance transparency and readability, building greater trust in clinical research.
Since the CTR went live on January 31, 2022, EU Member States and EEA countries have used the Clinical Trials Information System (CTIS) to fulfill their legal responsibilities in evaluating and overseeing clinical trials. For the first year of its implementation, until January 30, 2023, clinical trial sponsors could apply either through CTIS or under the previous Clinical Trials Directive. However, from January 31, 2023 onwards, all new clinical trials must be initiated exclusively through CTIS. By January 31, 2025, any ongoing trials originally approved under the Clinical Trials Directive must also comply with the new regulation, ensuring all information is recorded in CTIS.
This regulatory shift underscores the importance of patient-centric communication, with PLS playing a critical role. PLS not only help participants and the broader community understand clinical findings, but also promote a culture of openness and engagement in healthcare. By translating complex research data into clear, straightforward language, PLS bridge the gap between the scientific community and the public, allowing everyone to understand the latest clinical trials, regardless of their background.
The rise of PLS has brought a profound realization: democratizing information is essential to empowering patients. When researchers and healthcare professionals make their findings accessible, they foster a more informed and engaged patient community. This shift isn’t just about simplifying language; it’s about building trust and transparency. As PLS became more widely adopted, their impact is increasingly recognized. Patients gain confidence in their healthcare decisions, equipped with the knowledge they need to actively participate in their treatment plans. Healthcare providers, too, benefit from these summaries, which facilitate clearer communication and stronger patient-provider relationships.
Ultimately, PLS are more than just simplified clinical reports. They are a testament to the power of inclusivity in healthcare, ensuring that vital knowledge is not confined within the walls of academia but is shared openly and generously with all.
regulatory compliance with timelines
Under the CTR, sponsors must submit PLS typically within 12 months following the conclusion of a clinical trial. Ensuring compliance with these timelines is crucial to avoid penalties and maintain transparency with regulatory bodies. While the United States does not universally mandate PLS, initiatives like ClinicalTrials.gov encourage their use to improve accessibility.
Adhering to regulatory timelines is paramount. While regulatory requirements may vary across geographies, making PLS available at key study milestones is advised. The following best practices for creating and submitting a PLS include:
- at the start of the trial: Plan for the PLS from the beginning of the trial by outlining key messages and ensuring data collection methods support clear, concise communication.
- during the trial: Regularly update the PLS draft to reflect ongoing findings, ensuring it is ready for finalization promptly after the trial concludes.
- end of the trial: Finalize the PLS once the trial is complete and all data have been analyzed. Submit the summary to the relevant regulatory authorities alongside the clinical trial report.
- post-submission: Ensure that the PLS are accessible to the public through appropriate platforms, such as the regulatory databases, company websites, or patient advocacy group portals.
The implementation of Plain Language Summaries in clinical trials is a vital step toward enhancing transparency and fostering trust in medical research. By adhering to best practices in PLS timelines —from early planning and stakeholder involvement to timely release and effective dissemination —researchers can ensure that their findings are accessible to all. This inclusive approach empowers patients and the public, allowing them to make informed decisions and actively participate in their healthcare journey.
As the adoption of PLS continues to grow, so does the appreciation for their impact in democratizing information and bridging the gap between science and society. Stay tuned as we delve deeper into best practices for creating and translating Plain Language Summaries, making the complexities of science accessible and meaningful to everyone. At CQ fluency, we are committed to bridging the gap, one clear, concise summary at a time.
AUTHOR
Clio Schils
vice president, global life sciences
As VP of Global Life Sciences at CQ fluency, Clio ensures the highest quality and efficiency across a broad spectrum of clinical translations, from pharmacovigilance to linguistic validation. She has played a pivotal role in fostering global partnerships with leaders in pharmaceuticals, medical devices, biotech, and more. With a passion for patient understanding and advocacy, Clio continues to drive innovation in multilingual communication. Reach out to Clio and her team to learn how CQ fluency can help bridge communication in the life sciences industry.