The Impact of Translations on Clinical Trials

These days, hundreds of clinical trials enable pharmaceutical and medical companies all over the world to advance pharmacological knowledge and enhance patient care. Accurate, professional translations of Clinical Trial Protocols (CTPs) are a core element to conducting effective, safe international multi-centre trials: they facilitate the enrollment, treatment and monitoring of a diverse cross-section of participants at the same time. What’s more, efficient translations foster collaborative work among researchers from different countries and backgrounds.

While CTP translation has been considered important enough to warrant studies, it often comes too late in the planning of an international clinical trial, or falls short in terms of quality. With so much at stake, it’s worth going the extra mile with translations to ensure optimal comprehension and application of CTPs. If you’re weighing up potential translation partners for your Clinical Trial, here are some key factors to bear in mind.

Participation

Precise, clear and comprehensive CTP translations can ensure that participants feel as informed and comfortable as possible with the objectives, procedures and terminology of the trial. Doubts, confusion and misinterpretation inevitably lead to lower enrollment figures and higher dropout rates.

Consistency

CTP translations should be as uniform as possible, to ensure consistency in the trial results. A specialized pharmaceutical translation provider will help you to balance essential technical language and medical jargon with clear, approachable explanations. This is essential when it comes to combining scientific data with consent forms and patient Reported Outcomes (PROs), where “layman’s” language is more appropriate.

One version doesn’t fit all

Translating CTPs is about more than just linguistic transfer. A common complaint among international trial participants is a lack of country or culture-specific translations. An experienced translation provider will identify and respect cultural differences between countries involved in an international clinical trial. A sound understanding of ethics, values and behaviour is crucial, as these aspects can raise challenges – particularly regarding relationships with subjects, researchers and regulatory bodies.

Regulatory constraints

Some countries, like the U.S, make it compulsory to translate clinical-trial related documentation for all participants and researchers in local languages. Others, like Spain do not. While there is still a general assumption that most researchers have a proficient level of English, many regulatory bodies and ethics committees insist on the importance of local language documents – and with good reason.

Localization

These days, specialized translation providers help pharmaceutical and medical companies tailor their products and services to accommodate variations across markets and regions. Localization services encompass content, cultural and technical issues, variations in information, functionality and instrument design, and other aspects that facilitate quality assurance. It is especially vital when trials are conducted in culturally distant countries.

Behind every accurate translation is a specialized translator…

From clinical research and regulatory submission and review, to production and marketing. Working with experienced, specialized translators at every stage of the CTP process can save time, money and headaches.

Enlisting the help and expertise of a specialized translation provider from the very beginning of a clinical trial can ensure that resources are more efficiently assigned, delays prevented and the documentation provided is culturally and linguistically appropriate.