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why linguistic validation is crucial to ensuring eCOA is culturally and conceptually equivalent

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 using 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 several activities may contribute to an increased participation in clinical trials, as it gives patients and healthcare providers the flexibility of data completion from anywhere (home, clinic, etc.) making it more convenient for patients to fill it out and accurately record observations.  

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.

Best results through cultural accuracy

prevention of data inconsistency/conflict:

Guiding patients or clinicians through an electronic data collection questionnaire prevents them from entering inconsistent or conflicting data. It also increases the patient’s willingness to answer sensitive questions that they otherwise may not be comfortable answering in person. Pre-defined responses options are also a big help when it comes to data consistency. Also, eCOA ensures that patients are always asked the same questions in the same order at every visit, without error, variation, halo, bias, interpretation, or mood.

prevention of data inconsistency

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. Data quality issues will be detected in real time at data capture, such as inconsistencies, missing data, and others, eliminating the need to input them later.

ensuring quality control

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.


chronic disease treatments

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.

We at CQ fluency provide global translations and linguistic validation services including cognitive debriefing within both the clinical trial setting and in the real world. By providing value and data quality with our validated translations, we are aware of the importance that PROs and other clinical materials have as they demonstrate the value of new treatments in terms of health outcomes that are important to support regulatory approvals. 

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.

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