International clinical trials, are increasingly taking place in emerging countries, with many conducted in multiple countries simultaneously.
In a fiercely competitive pharmaceutical industry, speed to market is essential, which makes successful patient recruitment more important than ever. But communicating with multinational audiences is about much more than accurate translations.
A Conversis? Senior Project Manager, shares 10 lessons she has learnt from localising clinical trials.
1. Successful patient recruitment saves millions
Patient access and retention (PAR) programmes are a critical factor in the success of any clinical trial. 60 to 70% of study delays occur as a result of patient recruitment targets not being met. These delays can cost a fortune and cause major bottlenecks. In fact, a McKinsey report noted that taking a single month off a trial by improving recruitment could generate millions of dollars in savings.
2. Get the reading age right
All multinational clinical trials communications, whether patient brochures, radio spots or web campaigns, should be easy to understand. Ideally they should be written for a reading age of 10 or 12. You can?t afford to overcomplicate the message; it must be clear and unambiguous.
3. Avoid pejoratives and promises
Take for example the word ?drug?. While it is fine to use in US English, ethics committees in South Africa don?t like its usage, preferring to use ?medication? instead. Clinical trials materials must avoid phrases like ?suffering with?, and drugs should be referred to as ?investigative? never ?experimental?. Also product copy must not make promises ? a drug (or medicine) ?may (not ?will?) help with symptoms? etc.
4. Use translators with medical experience
As well as making sure your translators are native speakers, they must understand the intricacies of healthcare trials and have significant experience of translating similar materials. Which is why it?s important to always check the CVs of the translators working on your studies.
5. Get it right at source
It goes without saying that the importance of accuracy in medical translations cannot be overstated. Communications to patients must be as effective in the target market?s native language as they are in English. Which is why it?s crucial that your English source files are pristine. Any mistakes or typos in these original texts will be amplified by translation, particularly in large studies where 40 or 50 languages would need to be updated to correspond to any changes in the English. And with the rush to approve copy, mistakes are easy to make at source.
6. Beware of the missing font(s)
Indian languages are the hardest to control. India speaks several official languages and there are many different fonts. Often you?ll find that translation reviewers (including the local study teams) don?t have these fonts, which can delay a trial. It?s important to be aware of the software resources of everyone in the workflow and be willing to adapt the standard approach to find a solution that suits everyone.
7. Track changes
Always track the changes made by your translation reviewers. Even minor changes made by the reviewers are sent back to the original translators for their approval before the files are submitted to Ethics Committees. Translations are supplied to reviewers in Word with Track Changes switched on.
8. Don?t forget the ethics committees
Patient materials for multinational PAR programmes must be approved by ethics committees in all the participating countries. If you are conducting a clinical trial in 50 countries, then the communication materials need to be signed off by 50 separate committees. This can have a big impact on your deadlines. Most ethics committees meet only once a month or once every two months, so you have to factor this into the timelines. If your translations aren?t ready in time for these meetings, it can delay a trial by a couple of months.
9. Appoint a dedicated project manager
Having the same project manager for the duration of a clinical trial really helps. But it?s also important for others to be able to quickly pick up the work if extra help is necessary. At Conversis, we keep detailed tracking sheets for each study to ensure this is possible.
10. Review, review, review
Most important of all, keep reviewing and questioning your localisation process for clinical trials. The intricacies and complexities of these projects mean that no two studies are the same, which is why your chosen Language Partner should always be finding new ways to streamline the workflow. Global campaigns can?t afford to be scuppered by slow or substandard translations.
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