Since 1991, our company has specialized in translation, cultural adaptation and validation of Patient Reported Outcomes (PRO) measures and Quality of Life (QoL) instruments.
The terms “cultural adaptation” and “linguistic validation” refer to a multi-step methodology designed to ensure that the data collected with the same instrument in different countries are comparable across different countries. This is particularly important in clinical trials and medical research because even the very perception of quality of life, health and symptoms may be quite different in different nations.
During the 20 years of our existence we have developed an extensive network of local translators and physicians in almost 20 countries, and have conducted linguistic validation of hundreds of Health-Related QoL instruments (HRQoLI) in the fields of Cardiology, Endocrinology, Gynecology, Hematology, Oncology, Ophthalmology, Nephrology, Neurology, Psychiatry, Psychology, etc. We work with any indication and condition, including rare diseases. We have access to physicians of all specialties. Through this experience we have acquired a deeper understanding of the meaning and value of each step within the standardized methodology for cross-cultural adaptation and validation of PRO measures.
Validation methodology provides for rigorous translation analysis, for an input from medical professionals as well as from the patient population the instrument is intended for. It is also the best way to demonstrate content validity to regulatory authorities, such as the Food and Drug Administration (FDA), which states in the guidelines for the industry that “we recommend that sponsors provide evidence that the content validity and other measurement properties are adequately similar between all versions used in the clinical trial. We will review the process used to translate and culturally adapt the instrument for populations that will use them in the trial” (U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH) “Guidance for Industry – Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims” December 2009, p. 22).
Sergei Varshavsky, MD, PhD
162 Duncan Street
San Francisco, CA 94110
Phone: 1 650 575 2044
1831 Belmont Rd., NW
Washington DC 20009
Phone: 202 441 64 82