Here’s how to ensure your multinational clinical trials meet international guidelines

Here’s how to ensure your multinational clinical trials meet international guidelines

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With an estimated market size of USD 44.3 billion in 2020, the global clinical trials market is expected to reach USD 69.5 billion by 2028. This exceptional growth is primarily attributed to the increasing prevalence of chronic diseases, the growing demand for clinical trials in developing countries, the adoption of new technology, and the COVID-19 pandemic. As we look to the future of this highly regulated market, globalization of clinical trials, continued technological advancements, and the rising demand for Clinical Research Organizations (CROs) to conduct clinical trials are expected to further fuel its growth. 

The complexities of clinical trials when they become a global affair

CROs are becoming increasingly aware of the myriad of challenges when taking clinical trials globally. Governed by strict guidelines, an incorrect translation could result in delays, rejections, penalties or disciplinary action from regulatory bodies, adverse participant side effects or even fatalities. Unfortunately, many CROs don’t take translation into consideration during the planning phase. When left as an afterthought, translations can be inaccurate, which could result in serious consequences and undesirable effects on the clinical trial such as trial participants not being able to follow instructions, inconsistencies in taking medications, delayed or inappropriate followup/treatment, as well as the possibility of emotional or physical damage to clinical trial participants. 

When taking clinical trials across borders, CROs encounter regulatory differences that have to be taken into consideration. Let’s take a look at how translation requirements differ between countries. In the U.S., documentation including those for participants and investigators must be in the local language, however some countries assume that the majority of researchers are able to read and write English – making translation of these documents optional. What makes not translating these documents a stumbling block is that for review and approval the majority of regulatory bodies and ethics committees require documents to be in the local language. In addition, investigator brochures, clinical trial protocols, clinical trial agreements (CTAs), informed consent forms (ICFs), patient reported outcomes (PROs), case study report forms (CRFs), patient diaries, etc. need to be easily understood, indicating that these forms should be in the local language.

Although translation requirements may vary across nations, the importance of using professional language translators shouldn’t be underestimated. With so much at stake, CROs can’t afford for critical information to be untranslated or mistranslated. For this reason professional language service providers (LSPs) are becoming an increasingly critical component of clinical trials – both nationally and internationally. In fact, one can say that the success of clinical trials is largely dependent on timely and accurate language translation. 

Why an LSP is essential for your clinical trials

Extending across the many stages of clinical trials, from clinical research and regulatory submission through review and production to marketing, translation isn’t just about language and dialect, it also needs to take into consideration culture. Documentation for each of these stages vary and can include medical terms, technical jargon, and administrative terminology. With time and cost paramount to the success of your clinical trial, you need an LSP that will get translations right the first time. When shopping for an LSP, be sure the provider can deliver: 

As clinical trials continue to become more global, you’ll increasingly need to rise above the competition for a market advantage. Doing this cost effectively requires a LSP that has proven success in multinational clinical trial translations.

Streamline your next clinical trial with the right LSP

As the path to clinical trials becomes increasingly global, you can’t leave anything to chance. Instead of language translation being an afterthought, set your next clinical trial up for success by partnering with a qualified LSP. With the right LSP at your side, you can rest assured that translations will be done on time, with quality, and cost efficiently.

If you’d like to learn more about how BURG Translations helps you ensure high quality translations, contact us today.