The Importance of Proper Translation and Localization for Clinical Trials

While the bulk of clinical research trials during the past decade have been conducted in predominantly English-speaking nations, like the US, recent years have shown a shift toward globalization. With the rise in clinical trials being conducted outside of the US, the demand for a pharmaceuticals translation agency that can accurately represent the outcome of these trials is also on the rise.

Surprisingly, though the consequences of inaccurate pharmaceutical translations are serious, translation and localization services are often an afterthought. Finding a reputable pharmaceuticals translation agency is frequently the last step in the planning process for an international clinical trial.

However, one need simply imagine spending years and millions in grant funding researching a new Parkinson’s medication, only to have the FDA reject the data collected, to see how crucial translation services are to this process.

This article addresses frequently asked questions and recommendations for best practices designed to help researchers avoid this devastating result.

An Often Overlooked Aspect of Clinical Trials

Every new drug submitted for FDA approval must go through clinical trials. To be successful, researchers must follow clinical trial protocols (CTPs), offer up Patient Reported Outcomes (PROs) for evaluation, and make a compelling case that the drug is safe for humans to consume and doctors to prescribe. So it is crucial to design and implement clinical trials according to the strictest standards.

One often overlooked aspect of a well-designed, successful pharmaceutical study, is translation and localization services. Often clinical trial protocols (CTPs) are created in one country and applied in several locations with different languages, cultures, and values. But with differing clinical trial regulations, some trials are conducted without proper translations, often to save time or reduce costs.

Unfortunately, faulty translations may result in the failure of a participant to behave as required by the study. Other issues include disparities in prescription and administration of drug preparation, the reduced likelihood of follow up appointments, and failure to treat side effects. All of these challenges and more can affect a study’s success. The role of poor translations affecting the likelihood of lawsuits or rejection by regulators also should not be underrated.

Since proper translation should be involved throughout the process, improving the quality of translations can actually reduce the time needed and even save costs. So finding clinical translators is key to implementing trials and to helping researchers and the FDA interpret PROs.

The Importance of Understanding Clinical Trial Protocols (CTPs)

Every clinical trial requires a protocol describing the objectives, design, methods, and structure of the trial. Clinical trial protocols are formal, written documents. They are highly specialized and include a high level of technical complexity. Ambiguity of language must be avoided here.

The language used in CTPs is becoming more and more specialized as researchers aim to blend medical, administrative, and technical jargon (i.e., statistical terminology). Unlike other medical documents, terminology from different subfields of medicine must mix with laboratory protocols and terms taken from regulatory medical manuals. The language of CTPs is nearly unique to every individual trial.

On the other hand, not all documents related to clinical trials involve highly technical content, so it is important to take into account the audiences for each document. Translators must be aware that each participant has a different level of scientific understanding and different procedures to follow in relation to his or her role in the study.

For example, in order to standardize the conduct of the trial and facilitate communication between all individuals, those running the trial need access to several types of instructions, which could be placed in an appendix or on the data collection forms themselves.

Additionally, informed consent forms, which indicate a study participant’s agreement and understanding of the risks associated with the trial, must be easy to understand. A properly trained associate working for a pharmaceuticals translation agency will be able to navigate these different requirements.

The Localization Process for CTPs

Best practices for CTP translation requires multiple steps. The following steps outlined below are recommended for researchers looking to achieve the best outcome when working with translation experts:

• Create an institutional translation memory: Keep mind that clinical trials are rarely isolated events. You will likely want to return to a well-designed study for further information or to further explore avenues of research. It helps to have source materials, existing translations, glossaries, and public databases at your disposal. These make up your institutional translation memory.
• Create a terminology base from the institutional translation memory: It helps future translators if your pharmaceuticals translation agency keeps a running list of terms and consistent, acceptable translations for each term.
• Translate, edit, and proof the first round of translation: Ask to have a different translator go over the first round making edits and proofing the draft. Two heads are always better than one in these cases.
• Clinical review: Have a scientist fluent in the local language and familiar with the study, follow the CTP and take notes about where the translation could use improvement.
• Harmonization conference: Sit down with all the major participants to discuss the proposed changes to the original draft. Again, with the goal of eliminating ambiguity in order to prevent the rejection of the study due to inadequate translation, this step will solidify the unique language in your CTP.
• Final proof: Have the initial translator do a final proof for any tiny tweaks that need to made.

Today, many pharmaceutical companies increasingly need services that go beyond simple one-to-one translation and fall into the realm of localization. Involving not only linguistic transfer, by also content, cultural, and technical assistance. This is particularly true when it comes to studies conducted in emerging and culturally distinct nations in Asia, Africa, Eastern Europe, or Latin America.

Regardless of the aims of your study, when translation and localization are taken into consideration from the beginning, it is more likely that all resources can be efficiently assigned, delays can be avoided, and the documents provided will be understood within the cultural context.

Quality Assurance and Culture

Finally, it is important for researchers running clinical trials to take the proper steps to ensure quality assurance. With the influx of demand for pharmaceutical translation, the sheer volume of documents in need of translation in a short time frame can result in compromised quality.

However, if you find the right translator with the rare combination of professional translation skills and biomedical knowhow, you can be assured that your translation will be high-quality. The most important thing is to be realistic about your timeframe. A valid review process, once the initial translation is complete, can take as long as 15 weeks. Providing reviewers with online tools and outsourcing the review to an independent pharmaceuticals translation agency can speed things up slightly, but it’s always smart to build the time into your study schedule.

Cultural values and customary behavior can present benefits or obstacles for multinational clinical trials. Some cultures are naturally more compliant where participants tend to follow doctors’ instructions to the letter. However, with compliance may also come an unwillingness to report all adverse symptoms or events. What is undeniable is accurate translation of study documents plays an important role in the success of trials in any particular region.

With so many complexities and different steps to be completed by different team members, verification of CTPs and PROs can take months. The worst possible outcome of poor translation is serious injury or loss of life. More common is the expense of delays. As pharmaceutical companies and researchers look for efficiency wherever they can find it, clinical trial language management offers a key competitive advantage. Finding the right pharmaceuticals translation agency is a huge help here!

Translation and localization best practices are critical to delivering good data and maintaining a market advantage for clinical researchers. At Alpha Omega Translations, we have friendly experts who will provide guidance on not only translation, but also best practices for getting your clinical trial through the necessary regulatory channels. Contact us today for a free quote!

Tags: localization

Category: Translation Services