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Over the last several years, patient-centricity has been a key theme in the healthcare sphere for improving drug therapies and medical devices for patients all around the world. To better serve patients, life science companies are putting in more effort on listening to the patient’s story before, during, and after clinical trials. Because of this, clinical outcome assessments (COAs) are an integral tool for conducting clinical trials in collecting and analyzing real-world data (RWD) to improve the drug therapy or medical device. For multilingual clinical trials, COA translations are vital not only for complying with local regulatory requirements, but also for empowering the voice of patients of diverse backgrounds.

What is a COA and why is it important?

According to the FDA (U.S. Food and Drug Administration), a COA “is a measure that describes or reflects how a patient feels, functions, or survives.” There are several different kinds of COAs, including patient-reported outcomes (PROs), performance outcome (PerfO), clinician-reported outcomes (ClinRO), and observer-reported outcomes (ObsRO), all of which can be either hardcopy or digital, also known as eCOAs (electronic clinical outcome assessments). COAs are extremely important when conducting clinical trials as they are often used to measure how effective the treatment is. It is important for COAs, especially PROs, to word questions in a targeted way that protects the integrity of the clinical trial. An example of this would be, instead of asking a patient to rate their pain on a scale, which can lead to confusion in interpretation and analysis, to instead ask what their pain prevents them from doing in their day-to-day life, which can provide a much more tangible evaluation.

This means that for global clinical trials, accurate clinical outcome assessment translation is critical for clinical trial success. To gain valuable real-world information from patients of diverse backgrounds involved in clinical trials conducted across different regions and cultures, accurate adaption of questions found in COAs is necessary. Elements like weather, diet, or conceptual semantics can all affect how a patient responds to a question. Without proper adaption, patients of diverse backgrounds can either misinterpret or not understand the questions on a COA, jeopardizing the validity of a clinical trial.

What challenges are there for COA translations?

While there are no technical legal standards for translation of COAs, regulatory bodies like the FDA and EMA (European Medicines Agency) have released general guidelines to follow. In addition, the Professional Society for Health Economics and Outcomes Research (ISPOR) has also released recommendations on best practices for COA translation and adaption to “encourage harmonization between all stakeholders of interest.

When translating COAs, particularly PROs, a process known as linguistic validation is crucial in ensuring effective and controlled cross-cultural adaption of questions. Linguistic validation is a technique of reviewing and validating the accuracy, reliability, and equivalency for measurements of COAs. It’s a crucial component of translating COAs; failure to perform high-quality linguistic validation can cause serious errors in interpreting clinical trial data, which could mean risking regulatory rejection. In addition, as technology continues to advance, new methodologies of collecting, analyzing, and interpreting data from eCOAs is causing shifts in the global regulatory landscape for its use in global clinical trials. For pharmaceutical companies, contract research organizations (CROs), and other companies involved in diagnostics, partnering with a certified language service provider (LSP) that follows ISPOR, FDA, and EMA recommendations can save both time and money, as well as ensure high-quality translation and appropriate cultural adaption of COAs.

As clinical trials are increasingly being conducted in oversea markets, translating and adapting COAs to better fit the lifestyles of patients of diverse backgrounds is crucial not only in gaining market access, but also ensuring the medical device or drug therapy is safe and effective. Doing so also ensures that the voice of patient populations that have been previously overlooked in the past are heard, empowering minorities in the drug development process and as a result, improving global health.