Clinical Research Translation for Global Access to Medical Innovations

What Are Some Requirements for Clinical Research Translation?

As one of the most regulated industries in the world, the translation of all medical documents, particularly research documents, necessitates exceptional service. We provide three main requirements that must be fulfilled by your LSP of choice:

1. Precision

All medical translations should meet the requirements and standards set by international and national regulatory authorities and more so if they’re clinical research that involves real consequences on patients’ health.Professional medical translators deal with more than just precise word-for-word translation. They have to be fluent in medical terminology and have advanced knowledge of protocols, and medical translation types.As a highly technical field, medical translators can be specialized in different directions such as genetics, pharmacology, epidemiology, oncology, etc. They should also be up to date with the existing body of research and recent innovation in the field. As such clinical research translators can be classified as researchers in themselves since they have to deal with translational science which is the field of research aimed to understand the fundamental principles of science.

2. Compliance with Regulatory and Standard-Setting Authorities and Laws

In contrast to other studies, clinical research takes longer and follows a slower procedure to ensure no errors are made. As a result, a long chain of quality assurance and quality control processes is in place, with each country having a complex regulatory system that is also standardized by international bodies.To give you an idea, a principle of Good Clinical Practice (GCP) guidelines is that the well-being of the participant is more important than that of the study or society at large.As a result, even before the clinical trial begins, all risks should be meticulously measured, and the investigators should ensure that no harm will be inflicted on the participant. A clinical trial can begin only after regulatory bodies have reviewed and approved this statement’s accuracy.Another important element is record-keeping; Every step taken during the clinical trial is accompanied by a document that should be compiled and stored in a way that ensures accurate reporting, and allows for verification.In the United States, the Food and Drug Administration (FDA) is responsible for ensuring the safety and efficacy of drugs, biological, and device products in the United States. That includes regulating all research on new drugs or devices that intervene in human health to prevent, diagnose or treat different medical conditions. In the European Union, the equivalent institution is the European Medicines Agency (EMA). Other examples of organizations that set standards in clinical trials include:

• Japan’s Pharmaceutical and Medical Devices Agency (PMDA)
• Canada’s Health Canada
• Switzerland’s Swissmedic

Some global bodies that regulate clinical research include:

• International Compilation of Human Research Standards: This institution consists of over 1,000 standards on human subjects’ protection in 131 countries such as laws, regulations, and guidelines.
• CAMPUS for Regulatory and Ethical Requirements: Ensures that sensitive information and confidential data are protected and secure. 

3. Cultural Sensitivity

Personal experience and culture influence how the research community thinks about their questions, methods, and population. As a result, when translated to a new culture, the same procedures, questionnaires, and wording must be adapted to stay relevant to the new target population.In consent forms, patient information forms, and the like, patients should be able to clearly understand each word and sentence and not find it invasive, confusing, or, worse, offensive.Furthermore, cultural patterns must be incorporated into research design, conduct, and interpretation as well. By properly including different target groups and being aware of how they function, we ensure diversity which helps improve the outcomes of the study findings and their veracity.We must exercise extreme caution when copying and pasting the same clinical research document from, say, a Western perspective to a non-Western country. As a result, cross-cultural clinical research presents numerous challenges that necessitate cultural sensitivity on the part of the translation service providers as well.