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beyond the minimum requirements, however, it is considered good practice to translate the summaries into the local language of the countries in which the trial took place. This is in line with the good practice of translating patient information sheets and informed consent forms. From a readability and target audience perspective, local language summaries should be offered to all trial participants in their native language with culturally sensitive terminology adjustments as needed.
As EFGCP chair Ingrid Klingmann noted,
“ideally, lay summaries should have patient involvement in their development, as well as professional user testing of the master version and translations.... Early planning should protect budget for the lay summary and its translations.” In reality, translation budgets vary greatly depending on the type and funding of trial sponsors. From a language quality perspective, lay summary translations should include both a forward and a back-translation step by independent native translators, followed by a comparative review by a third independent reviewer. Such quality steps can pinpoint potential misunderstandings or discrepancies in the forward translation that can be adjusted during the translation process. The back- translation workflow can be replaced by a linguistic review, which should be considered a minimum quality assurance.
‘Faithful’ and automated translations Language is subjective, so any translation comes with a risk of misinterpretation once it reaches its target audience. Layperson summaries are no exception, especially given that the medical writer must transform complicated scientific results into a plain language summary. Successful translation cannot be quantified and is often referred to as a ‘faithful’ translation, which means that the translation successfully reflects the message in the source document and the intentions of the author. Besides inserting quality control steps such as back-translation and linguistic review, trial sponsors can include readability testing in the translation process with people representing the target audience or with the use of automated readability tools. Guidance documents for plain language communication often refer to known readability formulas such as the Flesch-Kincaid readability
score and the Flesch reading ease score. But these tools have their limitations. Using Lionbridge’s proprietary Linguistic Toolbox and automated lexical profiling technology, sponsors can obtain a more advanced automated readability analysis to aid the development and translation process for layperson summaries as well as other plain language content.
The complexity of simple communication At first glance, a layperson summary may seem like a simple task in the wider context of the resources and skills required for the execution and reporting of clinical trials. But authoring and disseminating objective and accurate summaries of clinical trial results in plain language from scientific source documents does require a mix of skills and knowledge including communication skills, scientific knowledge, translation skills, visual design skills, and insights into patient- relevant aspects of clinical trials. From a linguistic perspective, one particular challenge in authoring and translating successful layperson summaries is the difference between the scientific language conventions used in regulatory medical writing and the plain language needed to render scientific results accessible and understandable for trial volunteers. To tackle the transition from scientific to plain language, sponsors are encouraged to apply principles of health literacy and numeracy and to train resources involved in the writing, review and approval of the summaries.
Stepwise methodology
The GLSP guidance recommends a four-step approach to layperson summaries. It starts with an early planning phase during protocol preparation followed by three execution steps after trial completion including development, translation and dissemination stages. A stepwise approach helps ensure a smooth process, provides clarity in the selection and presentation of results, and guides how the layperson summary will eventually be disseminated to trial participants via direct dissemination methods (eg via the investigator), or indirect dissemination methods (eg via a webpage). A major benefit from a structured stepwise process is that a master layperson summary can be controlled and ‘locked’ in source language before the translation process commences.
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