MEDICAL TRANSLATION
Please can you provide some context regarding the motivations behind providing effective translations for all parties involved? Firstly, let’s look at this from the perspective of the pharma and biotech industry – its goal is to advance science, whether that be through a drug or a new device. It is therefore looking to advance health in humanity, and so translation is key to this to ensure the drug or device can be understood by all patients. Directors, investigators and research assistants want to involve trial participants; they want to have diversity and create a relationship of trust with participants. This will in turn improve engagement and retain those people involved. Language service providers want to provide an excellent service to keep their clients happy, to help them meet their needs. And lastly, medical translators want to do an excellent job with the translation; they want to refine their reputation and they want to continue business.
What is the role of regulation in translation? All research must be approved by the Institutional Review Board (IRB) and sometimes other regulatory associations such as the US Food & Drug Administration (FDA), the sponsor themselves or data-monitoring organisations. The IRB approves all informed consents and that is to ensure that the rights and the welfare of the subject are protected. These regulations aim to protect participants from coercion and undue influence. They have exculpatory language so that participants won’t feel guilty if they don’t participate or stay in the trial. The IRB review also ensures that the institution has complied with all the applicable regulations.
What is your advice for researchers to work effectively with medical translators? For researchers, an important tip is that we do like to have the final version of a protocol – and it must be finalised with no track changes. For the most effective review, we like to have it in Word format and it may help if someone else reads it just to make sure that it is finished. Another important tip is that it’s a good idea to use the same language for the product in the protocol as you do verbally. We’ve seen protocols that may say “the XYZ 500 device” and it turns out this device is an insulin pump, for example. This should be included in the protocol so that
78 | Outsourcing in Clinical Trials Handbook
“Use qualified interpretors. Bilingual staff may help too but make sure they have adequate and proven proficiency in the language. You want to engender trust so communication must be crystal clear.”
participants know what device you’re talking about. Then, for units of measurement, it’s essential to be as clear as possible. For example, make sure you put millilitres in your protocol as well as “spoons” as the volume of a spoonful can vary widely. Giving patients and trial participants as much clear information as possible in protocols is helpful as it allows them to know what to expect in the study. Another tip is to use qualified interpreters. Bilingual staff may help too, but do make sure they have adequate and proven proficiency in the target language. Remember you want to engender trust in your trial participants and so the communication has to be crystal clear. There should always be an adequate budget for language services in your clinical trials.
What are your tips for using adequate vocabulary in protocols that need to be translated?
I would advise researchers to always write the protocol as though it’s going to be translated right from the start. Please make sure there are no ambiguities or idioms that may be difficult to understand for a non-native speaker and try to use plain (or lay) language. Also check for health literacy in your participants: this is the level of their understanding of the health information provided, and it may vary. Explain the difficult terminology, because while patients understand best when you speak in plain language, they will encounter difficult terminology later on and so these terms need to be clarified. Make sure that you are taking on board feedback and ensuring that the protocol is written in the correct register, while upholding a high standard of professionalism and respect for your participants in all communications.
Another important tip is to know your audience, know your target population. Instead of
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100
