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Conducting International Clinical Trials During COVID-19

Jul 14, 2020

With people everywhere anxiously awaiting word of an effective treatment or vaccine for COVID-19, clinical trials have never before been so closely watched by so many. There are, according to one count, over 1700 novel coronavirus-related clinical trials underway around the world as of this writing.

Fast track approval

When a drug is urgently needed for a serious, currently untreatable disease, such as COVID-19, it may be possible to gain “Fast Track” approval, an emergency-case designation awarded as necessary by the FDA in the U.S and by other nations such as China and the U.K.

This recently occurred with Gilead’s drug remdesivir, which had already gone through clinical trials for treating Ebola. The Ebola trials ultimately proved disappointing for remdesivir’s efficacy in fighting that disease, though there were no questions regarding its safety. When COVID-19 arrived, Gilead revived remdesivir as a drug candidate because it did seem able to inhibit SARS-CoV-2 in vitro.

Granting fast-track approval for a COVID-19 drug that was known to be safe was an easy choice for the FDA, and remdesivir was made available for use by emergency physicians treating COVID-19 patients. The results, however, are mixed: While some limited data suggests remdesivir may shorten the duration of the illness, a large Chinese study of patients with more severe cases of COVID-19 found no statistical benefit from the drug.

Clinical trial documents

Pharmaceuticals are, of course, a field where the smallest details matter, and nuance can be everything. One of the trickiest, most critical, parts of international clinical trials is making sure that everyone involved shares a common understanding of the clinical trial process and its findings. That is why clinical trial document translation is required by law across the globe.

Every trial participant must be able to access all materials in their native language in order to avoid errors and invalid results. It’s also important to translate all documentation for those who will be planning, administering, and conducting the trials. This is the best way to ensure that no misunderstandings occur between parties operating in different regions, and that important implications and subtleties in one language are faithfully communicated to everyone involved.

How an LSP can help

When clinical trials are conducted internationally, clinicians, patients, sponsors and regulatory bodies must be able to communicate easily and with a high degree of accuracy. Engaging a qualified language service provider (LSP) such as Morningside increases the likelihood of better outcomes, ensuring that multilingual communication never stands in the way of a trial’s productive completion.

A good LSP can also help to quickly move a study forward by providing rapid turnaround of the necessary translated documentation, allowing medical research teams to meet critical regulatory deadlines. With the added pressure of finding a vaccine for COVID-19 as quickly as possible, quick turnaround is more important now than ever before.

If you are involved in COVID-19 clinical trials, feel free to contact us about how to achieve the best translation results. We are experts at translating and validating a wide range of clinical trial documents — from informed consent forms (ICFs) to questionnaires, COAs of all types and case report forms (CRFs). Our team of linguists consistently deliver accurate, culturally adapted translations for clinicians, review boards, and regulatory bodies.


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