Why do digitalized clinical trials require language solutions?

Today, over 70% of clinical trials use digital tools, from electronic health records to mobile health apps, showcasing a shift toward more accessible and streamlined research methodologies. The leap towards technology extends beyond mere logistical enhancement, representing a strategic approach to engage a broader and more diverse participant base. Such an expansion requires language solutions, especially crucial in decentralized clinical trials (DCTs) that leverage digital technologies to facilitate remote participation. These solutions ensure that all participants can fully engage with and benefit from digital clinical platforms. Adopting these solutions not only breaks down language barriers but also makes trials more inclusive and comprehensible globally, ultimately improving the quality and reach of clinical research.

At RWS, we specialize in language solutions that focus on clear, accurate, and culturally appropriate communication across all stages of the clinical trial process. Our expertise in this area can significantly contribute to the success of your clinical trials.

The rise of decentralized clinical trials (DCTs) resulted due to the need for flexibility during the COVID-19 pandemic. The transition to DCTs represents a shift towards more participant-centric research methodologies, where the convenience and safety of participants are prioritized. This model is particularly beneficial for reaching underserved populations or those in remote areas, thereby enhancing the diversity and representativeness of clinical research. However, the international scope of DCTs introduces significant communication challenges due to language barriers and cultural differences.

Effective communication in DCTs requires more than direct translation; it requires culturally relevant and understandable messaging. Tech-first language solutions are vital in ensuring that all digital content, from consent forms to treatment instructions, is accurately translated and localized. This ensures clarity and consistency in communication, critical for participant comprehension and adherence to trial protocols.

• Enhanced Data Collection and Management: Digital tools such as electronic Case Report Forms (eCRF) and electronic Clinical Outcome Assessments (eCOA) facilitate the remote monitoring of participants, improving the efficiency and accuracy of data collection. These technologies reduce the reliance on manual data entry, minimizing the risk of errors and improving the quality of data collected. This shift is crucial for trials that require precise measurement of participant responses and outcomes, ensuring that researchers can rely on the integrity and accuracy of the data for study conclusions and regulatory submissions.
• Improved Participant Accessibility and Engagement: The use of digital tools in clinical trials dramatically improves accessibility. Participants can easily access study materials and actively engage with the trial process from their homes or local settings. This positively impacts the retention rates and overall satisfaction of the trials, as participants are less burdened by travel and can manage their participation alongside daily life. Digital tools create a more inclusive trial environment by allowing underrepresented groups and individuals in remote areas to participate. 
• Cost-Effectiveness: Digitalization reduces the logistical costs of clinical trials by reducing the need for paper-based communications and in-person visits. Sponsors and research organizations benefit from decreased overheads and operational expenses, which can be redirected towards enhancing other aspects of the trial, such as participant recruitment strategies and advanced data analysis tools.
• Robust Data Security: Implementing digital tools requires rigorous data security measures to protect sensitive information and ensure compliance with global regulatory standards such as HIPAA and GDPR. The advanced security protocols integrated into digital platforms safeguard participant data against breaches, maintaining the trial's integrity and its participants' trust.