弥合语言鸿沟：通过翻译加强临床试验

Enhancing Clinical TrialsWith Translation Bridging The Language Gap: Enhancing Clinical Trials With Translation TABLE OF CONTENTS: Introduction .............................................................................................................................3Why translation is critical to patient engagement .........................................................4The specialist’s advantage ................................................................................................ 5Case study: The power of specialization ....................................................................... 6 Introduction Language solutions influence the speed and cost of clinical trials and the experiences of clinical teamsand patients involved in studies. The stakes are high: poorly implemented language solutions result inchaotic studies that take longer and cost more than expected, exposing entire trials to high risks. Equally, Sponsors must carefully weigh both the risks and benefits when implementing language solutions. Today,specialized, industry-leading language solutions are available to every sponsor, regardless of which CRO The need for top-tier language solutions is greater than ever. Phase 2/3 oncology trials use sites in 13.1countries, on average.1Studies beyond cancer are slightly less globalized, using sites in 8.4 countries, butsponsors routinely need to translate documents into multiple languages across all indications. Companies headquartered in China accounted for 30% of global trial starts in 2024, compared to 35%and 21%, respectively, for businesses based in the U.S. and Europe.2Single-country trials accounted for85% of studies run by emerging biopharma companies and 63% of trials initiated by larger companies. After decades of globalization, managing parallel translations for multiple countries is standard practicefor study teams. Yet, the task is still a cause of complexity, particularly when last-minute changes triggerrework across multiple languages, and tightening regulatory timelines are adding to the challenge. Amid “In clinical settings, precision isn’t just a virtue; it’s a regulatory and ethical imperative,” Richard Parnell,Vice President, IQVIA Language Solutions, said. Why translation is critical to patient engagement Patient-facing documents shape the experiences of clinical trialparticipants, the rate of enrollment and data quality. Studies have shownplain language and simplification to the documents can significantlylower consent anxiety, raise consent rates, increase patient satisfaction According to Melanie Johnstone, Associate Director, MedicalCommunication at IQVIA, the translation of “study drug” is the clearestexample of the nuance that is needed in clinical trials. IQVIA prefersthe term “study medication” but uses “study drug” when that is the “In some languages,‘drug’ can betranslated to meannarcotic drugs or “In some languages, ‘drug’ can be translated to mean narcotic drugs orstreet drugs and this would completely misrepresent the IP in the clinicaltrial,” Johnstone said. “This would give completely the wrong impression Sergi Martínez Torregrosa, Associate Director at IQVIA, said translationsaffect patient engagement and other metrics. Because engagedpatients are more likely to adhere to the protocol, accurate translations“improve the quality and the reliability of the study,” Torregrosa said. Given the high stakes, translators must go beyond literal languageconversion when engaging patients across diverse cultures andgeographies. Materials must be linguistically and culturally translated tosupport patient-centricity. Katy Thompson, Director, Regulatory Affairs at MELANIE JOHNSTONEAssociate Director Parnell advocates for integrating native-speaking subject matterexperts into the process to ensure translations “resonate with localpopulations.” The position is based on Parnell’s clinical experience,including a global diabetes trial that was being held back by low The team identified an educational pamphlet that used examples offood that were not common in the country as the cause of the lowengagement. Once local foods and culturally familiar terms were Johnstone provided another example of the importance of culturallycorrect translations. Some materials feature recipes to encouragehealthy eating or compliance with a particular diet. Measurements must “If we don’t make these changes then participants don’t feel valuedbecause it’s clear the materials were not really intended for them,” The specialist’s advantage Generalist language vendors, who work on everything from sneakers todrugs, lack the industry expertise to reflect cultural differences, adjust “For patient-facingmaterials, at least twopeople need to workon the translation.We recommend anadditional review of Specialized providers enhance speed, ease of implementation, qualityand cost control because they employ clinical trial experts and designworkflows and technologies to meet the