Last month, the FDA issued guidance designed to help clinical trial sponsors select, use, and optimize clinical outcome assessments (COAs) in their trials. The administration releases such guidance regularly, with the goal of helping the pharma and medical device industry use these tools appropriately before the FDA reviews them as part of the drug or device’s approval process.
As the FDA notes in its paper, this guidance strives to help sponsors use the highest-quality measures of patients’ health in their medical product development programs. High-quality measures better delineate what matters to patients, ensure clarity, appropriately evaluate the tolerability, safety, and efficacy of treatments, and help sponsors avoid misleading claims.
At RWS, we have an entire department dedicated to COA management, translation, and linguistic validation. We’re committed to serving the industry to the best of our ability, and our expert team and comprehensive processes help shape guidelines in this sector.
Incidentally, in this most recent guidance, the FDA referenced a paper co-authored by our own Shawn McKown, VP of Clinical Outcome Assessments. Shawn served as lead author of this paper, which focuses on best practices in the translation, cultural adaptation, and linguistic validation of ClinRO, ObsRO, and PerfO measures, in his role as the co-chair of the TCA-SIG; a translation special interest group within the International Society for Quality of Life Research (ISOQOL).
What the guidance says
This new guidance focuses on helping sponsors ensure high-quality measurement of patients’ health during medical product development, including during clinical trials. As the guidance notes, “Ensuring high quality measurement is important for several reasons: measuring what matters to patients; being clear about what was measured; appropriately evaluating the effectiveness, tolerability, and safety of treatments; and avoiding misleading claims. Such findings may help support regulatory decision-making in a variety of contexts.” This guidance effectively gives trial sponsors a roadmap for selecting, modifying, or developing COAs.
Part of this guidance addresses the importance of COA translation. According to the document, trial sponsors or COA developers “should consider the most likely interfering influences on responses to items or tasks and assess the presence and strength of those influences.” In trials that include patients who speak multiple languages, a lack of linguistic or cultural understanding could be an interfering influence. It is thus crucial that sponsors ensure their COAs can be understood and utilized by all trial participants, regardless of their native language.
The guidance notes: “For some trials, COA instruments are used for patients with diverse linguistic and cultural backgrounds. Therefore, it is important to show that such differences are unlikely to influence response to COA items. It is recommended that translation, cultural adaptation assessment, and linguistic validation are conducted early in the COA selection and development process following good practice methodology (Eremenco et al. 2017; McKown et al. 2020; Wild et al. 2005).”
As the guidance notes, it’s critical that sponsors demonstrate that all patients can understand the COAs they employ in their trials. This new guidance recommends that sponsors “describe in detail the process of language translation and/or cultural adaptation (including cognitive interviews) to support the quality of the resulting translation and/or adaptation.” By demonstrating a robust, comprehensive translation and cultural adaptation process, trial sponsors can reassure the FDA that all patients understand a given COA’s instructions, items, tasks, and response options.
We’re COA Experts
At RWS, we’re COA experts—and our robust process allows sponsor clients to comply with the FDA’s recommendations regarding language translation, cultural adaptation, and linguistic validation.
We’re an industry-leader when it comes to linguistic validation: a critical process that ensures translated COAs are linguistically and culturally accurate, so trial sponsors can use them to demonstrate the patient’s response as accurately as possible. Our process relieves pressure from sponsors; we manage the entire lifecycle of COA translations and work across all COA types. We’ve particularly specialized in linguistic validation since 2003 and have linguistically validated over 20,000 COAs into 500+ language pairs in over 200 different specific therapeutic areas over the past two decades.
Ultimately, our team is our greatest strength. Our experts are well-versed in the latest guidance—indeed, some even contribute to it. When you work with RWS, you’re working with professionals who understand the needs and nuances of trial sponsors, and who are always seeking to apply new, innovative approaches to their needs.
Click here to learn more about how we can help you navigate your COA/eCOA linguistic validation challenges.