Over the last 20 years, the worldwide number of clinical trials has increased exponentially. Clinical trials also become more complex, with the adoption of multi-center, international interventions becoming the norm. This means that the pharmaceutical industry is confronted with the exponential growth in costs associated with running such clinical trials, with each molecule requiring approximately US$48 million to develop. A new layer of complexity was added with the COVID-19 pandemic, when numerous trials have been delayed or postponed, with resumption happening at a slow pace.
While decentralization of clinical trials has been a growing topic of discussion and development over the last few years, the pandemic created an inflection point for the pharmaceutical industry to start evolving their traditional site-centric clinical trial model, aided by the advancement of available technologies.
One rapidly expanding area is the use of technology-enabled data collection, such as the use of wearable sensors to collect electronic clinical outcome assessments (eCOAs), facilitating the acquisition of more data, as well as having real-time insights into patient safety. However, one of the main challenges in collecting accurate patient data is guaranteeing that COA measures are culturally relevant and accurately translated for each target market.
Improving data quality with eCOA
Moving from traditional, paper-based methods to digital forms of collecting COAs is a more reliable and cost-effective way to retrieve clinical data. Outcomes can be recorded through the use of specific apps installed on the patient’s smartphone, complying with the important endpoints to be gathered and ensuring that no data is forgotten or lost. The increase in smartphone ownership among Limited English Proficiency (LEP) communities and their reliance on such devices for a number of activities may contribute to an increased participation in clinical trials, but also shape the way they log the required data.
Here are some of the ways the use of eCOA can improve clinical data quality:
- Increased patient compliance: Patients using ePROs demonstrate significantly higher protocol compliance. Electronic reminders/alerts, animated compliance feedback and dynamic, context-sensitive messaging, allows for data capturing in real-time, delivering accurate, reliable information on patients’ trial experiences. The use of alerts can prompt the patient to record an outcome (e.g., pain score) at a given time, avoiding recalling bias when such data is recorded later.
- Prevention of data inconsistency/conflict: guiding patients or clinicians through an electronic data collection questionnaire prevents them from entering inconsistent or conflicting data.
- Elimination of transcription errors: human errors are inevitable when transcribing data from paper forms into digital ones; the elimination of the paper step avoids such errors.
Ensuring consistency in the collection of high-quality data across all sites of a complex, multicenter clinical trial—one that includes a diverse patient population speaking different languages—is a challenge that requires proper management of linguistic nuances. That is why culturally relevant and scientifically accurate translations are a fundamental aspect of eCOA planning.
Translation and cultural adaptation of eCOAs
To ensure consistent interpretation of the collected data in diverse cultural groups, eCOAs must go beyond translation—linguistic validation is essential. An eCOA that did not undergo a linguistic validation process may jeopardize the validity of research data and impair the ability to pool global data sets.
This is especially true for clinician-, caregiver-, and patient-reported questionnaires and diaries because they provide information that plays a crucial role in whether a device or medication reaches the market. A well-translated text has the same meaning as the original. However, in questionnaires used in clinical trials with a multilingual population, it’s more effective to aim for construct equivalence than just equivalent meaning. For example, if one questionnaire item calls for the “ability to ingest soft foods, like pancakes”, the example food given should reflect the type of foods that are common in the culture and country for which we are adapting our questionnaire. Other examples include types of physical exercise, equivalence in pain scales, or examples of daily activities, which illustrate the need for revision by a subject matter expert linguist.
But how exactly do we achieve this complete linguistic equivalence? Take our cognitive debriefing process, for example. This is just one of the steps necessary to confirm content validity in all translations, which is particularly important considering that a mistranslation or even a misunderstanding of a translation could result in an entire clinical research project being rejected. At CQ fluency, our cognitive debriefing includes partnering up with small and medium enterprises to deliver exceptional quality and cultural relevance from start to finish, ensuring cultural and technical accuracy for all your clinical trial materials and for your target population, including children and the elderly. For this process, we handpick talented linguists who are fully trained for this scope of work and interacting closely with trial participants.
CQ fluency’s linguistic validation processes are based on self-correcting iterations that deliver complete psychological similarity. By going beyond the minimum requirements and focusing on global clinical trials, we achieve meaningful texts for the target audience, allowing our clients to collect accurate, meaningful data. Our approach to linguistic validation is managing it as a holistic research activity as opposed to a ticked check-box.
Excellence is in the details
While clinical trials are getting bigger and enrolling more people from diverse backgrounds, it may be tempting for multinational pharmaceutical companies to massify their procedures in an attempt to be more efficient. However, to protect the integrity and value of eCOA data, it is paramount to take linguistic validation and cultural adaptation seriously from the start—failing to do so can invalidate the clinical data collected and endanger market access for the intervention, leading to major financial losses.
At CQ fluency, we understand the pharmaceutical industry needs trustworthy translation services, especially in highly regulated markets such as healthcare and clinical trials, but we also recognize the demand for efficiency in such fast-paced areas. That is why we are leveraging technological innovation and automation to extend our translation capacity and enhance risk management in collaboration with drug safety departments, taking advantage of tools like machine translation, centralized glossaries, and translation memory to mitigate risks. Our dynamic approach is rooted in our unique attitude toward technological innovation—we are continually developing and customizing one-of-a-kind technologies based on client needs, setting us apart from other language service providers.
The best way for health sciences companies to ensure eCOAs have appropriate linguistic validation and cultural adaptation is to partner up with an experienced provider. At CQ fluency, we go beyond clinical document translation, we ensure cultural relevance of all your clinical trial materials. Contact us today to discuss your specific needs.