13 Nov The role of medical translations in decentralised clinical trials

Ten years ago, we could not have imagined that COVID would change our lives. Nor could the pharmaceutical companies. In fact, the pandemic forced a rethink of the system in which clinical trials required participants to make numerous visits to hospitals, companies, universities and research centres, as such travel was not safe. This led to the rise of decentralised clinical trials and, consequently, to medical translations in these trials. Here’s how and why:

What do we mean by decentralised clinical trials?

Plain and simple: those that leverage technology to cover aspects of a trial from the patient’s home or office, without the need for hospital admission, allowing individuals to participate from home and researchers to use technology to communicate with volunteers. Only now have they really come into their own, making it easier for a more diverse population to participate in clinical trials.

The benefits of decentralised clinical trials

The benefits are immense: they can improve the comfort of trial participants, expand access to more diverse populations, improve trial efficiency and facilitate research into rare diseases and diseases affecting populations with limited mobility…

• Patient care: it is more convenient to receive a video call at home than having to travel to the company, hospital, research centre or university premises from time to time.
• Better patient recruitment: Reduced site visits also geographically expands the boundaries for recruitment, making it possible to reach untapped locations such as rural populations.
• Increased participation. Increased accessibility for people with rare diseases or mobility problems, which will facilitate drug development, including in areas of medical need.
• Reduced costs and increased efficiency: The costs of operations at a physical site can be exorbitant. In a decentralised trial, the involved entities reduce or eliminate many site fees.
• Patient diversification: Due to the global accessibility of trials conducted in different locations, cultures, languages and ethnic groups, they help achieve diversity in clinical trials.
• Optimised data collection and more accurate reporting: Most of the experiences you are trying to capture occur at home, at work, or in some other aspect of daily life. In a decentralised clinical trial, participants can report and record their data in the moment.

The future of decentralised trials after the end of the pandemic

Although the pandemic seems to have come to an end, we have adopted new ways of working that are here to stay, such as teleworking. The same goes for decentralised testing.

The pandemic has been the perfect opportunity to demonstrate its effectiveness and its importance for the advancement of research, so the mindset has shifted to a future where decentralised testing can help solve problems and enable a more innovative future that will be enhanced by expertise and advances in technology and communications.

In addition, there are many factors driving the growth of this market: the demand for faster and cheaper drug trials, the increasing number of patients willing to participate in remote clinical trials, and the availability of electronic patient-reported outcomes, sensors and wearable devices that can capture patient data in a less cumbersome way.

What role do medical translations play in this context?

Decentralised clinical trials are conducted at multiple sites or even in the comfort of the participant’s home. Due to the diversity of regions and cultures involved, clinical trial translation services must translate documents such as informed consents, study protocols, procedure manuals and study results into the local languages of each participant. This ensures that all involved fully understand the procedures, risks and benefits, improving the safety and accuracy of the data collected.

Clinical trial translation in these kinds of trials must not only be scientifically accurate, but also culturally sensitive, as clear and effective communication is key to the success of trials and, ultimately, to the development of safe and accessible treatments worldwide.