SubscribeThis article discusses some language and translation aspects of international clinical trials, and how a poorly translated 2-page document can delay the registration procedure.
These delays can shorten the patent protection period, costing up to $2 million per week.
Clinical Trial Documents
During clinical trials a range of different documents are used. The documents include Study Protocols, Informed Consent Forms (ICF), Investigators’ Brochures (IB), Patient Reported Outcomes (PRO) forms, Subject information leaflets, Case report forms (CRF), Adverse Events (AE) forms, Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and so on.
Clinical Trial Languages
Clinical trials have become increasingly international and therefore more and more languages are involved. Increasingly, trials are held outside of Western Europe and North America. For example, the number of trials held in Bulgaria increased from 15 in 1996 to 175 in 2006. Most countries have their own (official) language, while some have more than one official language (Belgium, Finland, Switzerland) and other countries share the same language (Spain, Argentina), but with differences. Trials are also frequently held in Africa an Asia, where countries may have several official languages (South Africa and India each have around a dozen) and even more unofficial languages, and trial participants may understand just one of those.
Cost-Benefit of Clinical Trial Translation Quality
The cost of setting up and running clinical trials are considerable and therefore it is crucial that the language aspects are taken care of professionally, in order not to jeopardize the results of the trial. What good does it do to have set up a trial infrastructure, complete with study centers, investigators, physicians, nurses, and recruitment staff, if at the end of the day the patient or study subject does not understand the Informed Consent Form? Or if a participating patient does not understand the wording of a question in a questionnaire? Or if part of the research data can’t be used because translated questions don’t mean the same in all languages. And if questions are not the same, the answers can’t be pooled! This is a very real problem for clinical trials and it is even more valid for manufacturers of new medicines. It is understood that developing a new medicine costs around $1 billion, which must be earned back during the patent protection of approx. 8 years (or $2 million per week).
When marketing authorization is applied for, up to 50,000 pages of dossier information are forklifted (paper) or PIM’d (electronic) over to the EMeA. But if a 2-page patient information leaflet has not been translated well enough in just one of the 25 languages, the Europe-wide registration procedure may be severely delayed, while the clock of the patent protection period is ticking! And even if poorly translated leaflets do survive EMeA scrutiny, they may still be so complicated or unclear that patients simply don’t know how to use the medicine and may decide not to take their tablets at all or take too few or too many of them, and the effect is then either zero or adverse, respectively. When these effects can be linked to unclear instructions this may lead to liability lawsuits!
Risks of Translation Cost Savings
A professionally done translation of a 1,500-word leaflet costs less than Eur 350 per language. Probably, one can try to get this done for Eur 200 and ‘low-cost’ does not always have to mean ‘low-quality’. But why save a few hundred Euros and risk a delay in the registration procedure? Why accept the risk that on Day 215 of the regulatory calendar for central procedures one or more of the two dozen language versions are thrown out?
Why take the risk?
There can be many different reasons why companies would take risks like these, but these often include one of the following:
Unawareness: Many pharmaceutical companies and CROs employ pharmacists, chemists, medical doctors, and others with a science-oriented background. They are typically not language people, and they may simply not be aware of the problems a poorly written text may cause.
Cost: Compared with the total cost of clinical trials, translation costs are negligible, and should never be an issue. The difference between a job well done or poorly done is a few hundred Euros per language. But perhaps that is exactly the problem: because the translation costs are so low, translation does not get the attention it so deserves.