Clinical trials around the globe are growing at a rapid pace and due to this, translation services for these complex and sensitive documents are in high demand. According to ClinicalTrials.gov of the U.S. National Library of Medicine, there are already 277,228 registered clinical trials from around the world in their database from January to July 2018. In 2016, the total for the entire year was only 262,446. ClinicalTrials.gov is a global database of publicly and privately funded clinical studies.
Need for translation services
Clinical trials are conducted in many places around the world and the speed of their expansion means that more translation services are needed. The globalization of clinical trials conducted by clinical research organizations and pharmaceutical companies had a deep effect on the way the trials are conducted.
In medical translation, one of the many challenges faced by translators is medical terminology. With clinical trial translations, translators have the added responsibility of handling different languages and cultures, making the translation process more complex. It is likewise of utmost importance to have the documents accurately translated.
There is no room for even the minutest of errors in clinical trial translation. From finding the right language services provider (LSP) to the review process of the translation, expert translators and linguists are critical in ensuring that the results of the clinical trials are cost-effective, efficient and globally successful.
Clinical trials are regulated by several strict guidelines. They encompass a standard for ethical practices, an in-depth review process and a ton of paperwork. Clinical trials are able to have a profound effect on the pharmaceutical industry that is worth billions of dollars. Every new drug and medicine that the industry produce must undergo a clinical trial.
While some clinical trials only last for several weeks or months, it takes about 10 to 15 years before a clinical trial for a new drug is concluded. A clinical trial undergoes three or four phases, so it is understandable that the project typically involves mountains of written documents. Given this scenario, you can already gauge the amount of work translators have to do when accepting a clinical trial translation project.
The project demands hiring excellent linguists who are subject matter experts. Thus, for a pharmaceutical company or a clinical research organization, it is critical to have a strategic translation plan to ensure a seamless process to achieve the expected results.
Have a translation strategy
Clinical trials have their own set of jargon and terminology, which can become very complex when the documents are written in languages other than English. This is something that should not be underestimated by a company’s translation manager. The entire process can be compromised by a single error. It is vital that the standards and strategy for the translation are set at the start of the process.
The recommendation is to find the right LSP and determine the linguists who will be working on the project from the start, even before the company recruits participants for the clinical trial.
This strategy helps the company establish a streamlined process from the beginning. The LSP should be able to set procedures to prepare a solid plan to meet the particular needs of the product and find the right translators for the job and ensure that translation quality is maintained from the start.
Aside from the comprehensive plan or clinical trial protocol and the documents that will be produced during the trial, the expert translators also have to translate other clinical trial-related documents, such as informed consent forms and clinical trial agreements.
Establish integrated translation processes
The company must establish a process that integrates all actions, including the tools to be used and the translators. It is better to work with one LSP and have a centralized translation memory system for each target language to ensure consistency in the terminology and increase the speed of translation.
Clinical trial translations have several important steps compared to standard translations. This ensures that the translations are accurate, acceptable and complies with the requirements of the International Society for Quality of Life Research (ISOQOL) and the International Society for Pharmacoeconomics and Outcomes Research. These organizations validate the translations of clinical trials.
Establish a review process
Standard translations are reviewed by a copy editor and a proofreader before they are approved by the project’s translation manager. The requirements for reviewing translation of clinical trials are more stringent.
You can ensure that the review process is streamlined by collaborating with a translation company that is an expert in clinical trials. It is to your advantage if the LSP is amenable to working directly with your reviewers, whether they are external or internal, to see to it the translations meet your standards. A professional and expert LSP will ensure that the language quality is above par, which will help speed up the review process.
Globalization of clinical trials
Although there are clinical trials that are conducted in their country of origin and are utilized there, many more clinical trials are going global as well. The trend today is to delocalize clinical trials and conduct them in emerging countries. Because of the new trend, translation and localization are becoming increasingly necessary. There are several instances where the clinical trial protocols are created in one country and implemented in different locations where the cultures and languages are different. Therefore, clinical translators are essential in the proper implementation of the trials.
Gaps in global clinical trials
It’s a fact the inaccurate translation is a very serious matter because it affects the economic revenues of various stakeholders, company credibility and the lives of humans. However, there are still many international companies that do not give more importance to translation.
Accurate translation is important anywhere you go. If a clinical trial is mistranslated, the participant may not be able to follow the instructions and there could be differences in the prescription and administration of the preparation for the study. The required follow-up may be reduced and the treatment of inherent conditions resulting from the side effect of the clinical trial may be decreased.
Faulty translation may also cause emotional or physical damage, waste of money and time and the trial labeled as misconducted.
Responsibility to translate
Different countries have varying obligations when it comes to the translation of documents related to clinical trials. In the U.S., every document for the participants and investigators (researchers) should be in English. In other countries however, if is often assumed that people conducting the experiments know how to read and write in English. Therefore, for them, it is not necessary to translate the documents that pertain to them even if the ethics committees and regulatory groups require that all documents submitted to them for review and approval should be in the local language.
Due to the differing regulations in international clinical trials, some of them are conducted but not fully translated. Some do this as a means to shorten the time before the trial is approved. It can be because they want to minimize the costs. However this would be detrimental to the trial’s results.
For clinical trials it is important for the translators to be involved in the various stages of the experiment, from the research period to the submission of documents to the regulatory bodies for review. Translators are also involved in the production and marketing of the trial therefore, with high quality translation services, the company can decrease its timeline and save money in the process.
Accurate translation minimizes the risk of rejection of the results by the regulators. It can help avoid lawsuits and improve the efficiency and safety of the final product.
Clinical trial protocols are very specialized documents that have a high level of technical complexity. They need accurate, concise and clear style to prevent anything from being unclear. Today the language used in clinical trial protocols is a mix of technical, administrative and medical terminology that is not seen in other medical documents. The terminology is often unique to each clinical trial.
Not every clinical trial-related documents use very technical terms and translators must consider the users of the translation. It is important to consider that the level of understanding of the participants is different.
Clinical trials are important and translation makes the clinical trials available to all concerned users. Here are some things to remember:
- Make sure that your company develops a strategic plan for translators to be involved from the very beginning of the project.
- Follow the standard processes and establish the stringent review methods. Work with a language services partner that has the right experience handling clinical trial translations.
- Your LSP partner should understand the regulations in different countries and could provide you with the solutions for regulatory dossier submissions, management of the master file, labeling and version control. When all your processes are streamlined, your time and resource allocation to review and submit the documents decreases.
The professional medical subject matter experts of Day Translations, Inc. have vast experience in handling medical translations, such as clinical trials and have worked with some of the major pharmaceutical companies. We are HIPAA compliant and we guarantee the accuracy of all our translations, whether they are standard translations or something as complex as clinical trial translations. Our translations come with a Certificate of Accuracy to guarantee our work. Collaborate with us for your medical translation requirements. You can reach us by phone at 1-800-969-6853 or send us an email at Contact us. Our offices are open 24/7 so we can immediately respond to your translation needs anytime, anywhere you are in the world.