With the increased threat of COVID-19, and country-wide lockdowns in effect, pharmaceutical and contract research organizations (CROs) are evaluating the impact to current clinical trials. According to a recent article in FierceBiotech, the COVID-19 pandemic has forced companies including Eli Lilly, Addex Therapeutics, Iveric Bio and Provention Bio to rethink their clinical trial programs. Many sponsors are pausing or delaying the start of new trials given the safety challenges to enroll and dose participants. Trial continuity is important, especially for patients who actively rely on medications or therapies.
Decentralizing clinical trials could ease the burden as health authorities struggle to react to COVID-19. With mounting pressure, on March 19 2020, the U.S Food and Drug Administration (FDA) issued Guidance for Industry, Investigators and Institutional Review Boards on the Conduct of Clinical Trials of Medical Products during the COVID-19 pandemic. Requirements have been eased for adopting alternative methods to collect safety assessments by phone, conducting virtual visits to gather patient data and remote safety monitoring.
With patient centricity on the rise, virtual clinical studies are removing physical and geographical barriers and virtualizing patient reporting, interactions with doctors and study management teams.
While these are viable alternatives to conduct virtual clinical trials, consideration must be given to non-native language speaking study participants, healthcare providers and caregivers. A wide variety of patient-facing digital technologies are deployed to support virtual clinical studies. These may include wearable sensors, ePRO, tablet and smartphone apps, video telephony, patient portals and a variety of electronic data capture tools.
These patient-facing technologies add additional challenges where local or native language is concerned. This goes beyond translation and localization of clinical trial documents—normally associated in a ‘traditional’ randomized clinical trial. Now consideration must be given to the various patient-facing interactions—this includes target language user interfaces, real-time virtual interpretation, translating documents for regulatory authorities, informed consent forms and other patient-related materials.
Language plays an even more important role when it comes to virtual clinical trials. Patients must adapt from face-to-face interactions to digital. The precise meaning of what’s being communicated is critically important to ensure patient reported data is accurate.
When implementing global virtual clinical trials, sponsors need to consider these best-practices when selecting a language partner:
- Proven experience providing over-the-phone interpretation (OPI) and video remote interpretation (VRI).
- Expertise and resources to translate not just words, but the meaning and cultural nuances for patient responses with experience to culturally adapt content for the layperson and clinical audiences.
- Ability to leverage the advances in linguistic artificial intelligence to amplify translation output.
Implementing or converting to a global virtual clinical trial impacts trial documentation and digital communication based systems which require a thorough evaluation, modification or in some cases updated formats. Clinical trial managers should consider the impact and solutions for the following:
- IRB/Independent Ethics Committee documents
- Protocol amendments
- Telemedicine (dubbing and subtitling)
- Patient and PI education (eLearning and documents)
- Safety monitoring
- Multilingual chat
- Mobile device applications (multilingual formats, testing, content delivery)
- Remote patient monitoring
Our experience and our technology solutions are our differentiator—we are the trusted translation partner for 6 of the top 10 CROs, and offer pharmaceutical and biotechnology expertise. We deliver translation services to support documentation and communications throughout the entire study lifecycle from study setup through submission. SDL’s OPI/VRI service connects your clinical trial participants to highly qualified interpreters to achieve understanding, regardless of language. Our verification process ensures interpreters have proven ability with clinical expertise to meet the highest standard of service. We deliver fast access to interpreters, in a simple and secure environment, with 24/7/365 support by phone, email or live chat.
Our in-house team of 1300+ translators, with expertise in 30+ therapeutic areas, you can feel confident that your virtual clinical trial content is clinically accurate and meets regulatory requirements.
Published on March 31, 2020 in Life Sciences