Clinical research is fundamentally changing: First clinical trials are going global and second Quality of Life (QoL) data is becoming more and more important during drug clinical research.
QoL data has always been part of clinical research, of course. Recently though there have been a couple of developments that have pushed QoL into the foreground: On the one hand, pharmaceutical companies are looking for non-scientific justifications to broaden the claims for their medicines. On the other hand, patients are increasingly interested in minimizing side effects of the treatment that they receive so that they can go on living as normal a life as possible.
The challenge is that QoL data, which is almost synonymous with patient-reported outcomes (PROs) in clinical trials, is highly subjective and thus open to "creative" marketing claims. That is difficult enough for English-only trials (most QoL questionnaires are written in English) but becomes a real challenge because of the above-mentioned globalization of clinical research.
The translation and validation of PROs is a laborious (read: time-consuming and expensive) process that seems foreign to most medical translators. (You can get a sense of the complexities by reading Initial validation of the Argentinean Spanish version of the PedsQL™ 4.0 Generic Core Scales in children and adolescents with chronic diseases.)
Luckily, there is help available. the excellent Linguistic Validation Manual for Patient-Reported Outcomes (PRO) Instruments provides the "gold standard" for the translation and validation of PROs.
The book is divided into six easy-to-use chapters and provides lots of hands-on information such as process diagrams and decision-making trees.
While Linguistic Validation Manual follows the basic process outlined in Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: Report of the ISPOR Task Force for Translation and Cultural Adaptation and others, it also goes beyond it. For instance, the book provides more details regarding participants, different types of process flows, and variations in languages (i.e., questionnaires that were developed in languages other than English).
Linguistic Validation Manual is highly recommended for anybody interested in learning about the translation and validation of PROs.
For further reading, also take a look at:
- Our recent audio conference on Translation & Linguistic Validation of PRO Measures
- Ideas for using translation memories in clinical research settings
- FDA's draft guidance on PROs
ForeignExchange Translations provides specialized medical translation support for all stages of drug and device clinical research.
Categories: clinical research