Role of Translation in International Clinical Trials

A well-designed and implemented clinical trial involving researchers, scientists, physicians, clinics, pharma, and life sciences companies, CROs, and regulators – is critical as it guarantees the safety and effectiveness of drugs and medicines and helps avoid such disasters.

With technology breaking down the barriers of communication and patient-centricity gaining momentum, patient engagement has become a critical factor in clinical trials.

Why is translation necessary for international clinical trials?

In recent years, clinical trials have become a global affair, with clinical trials being conducted in many emerging countries. Clinical Trial Protocols (CTPs) developed in the land of origin must be implemented in locations where there are differences in languages and cultures.

To ensure the proper and successful implementation of clinical trials globally, the organization and management of the linguistic translation of the materials involved in these trials become critical in the success or failure of such clinical trials.

Good translation bridges communication gaps in countries and cultures where different languages are spoken when done correctly. Consequently, inaccurate translation can cause a breakdown in communication which can be extremely serious in terms of human lives, the credibility of the clinical trial, and ultimate economic revenue.

Yet, translation is often the last factor to be considered in planning a global clinical trial.

How to properly manage the translation of Clinical Trial Protocol (CTP)?

\When translating the CTP, the recipient of the translation, the clinical trial participants, must also be considered.

In the translation of CTP, it is vital to consider the following process:

  • Create Translation Memory (TM) from existing source materials and its corresponding approved translations.
  • Create a terminology from the approved translation
  • Mandate Translation-Editing-Proofreading process with each process handled by independent linguists (ISO 17100)
  • Review
  • Back Translation (if applicable)
  • Final Proof

With the extensive process taken for translation, review, back translation, and validation, the final approval of multilingual CTP may take months. However, this is a critical process, which may have a serious adverse effect on the clinical trial when skipped.

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