Authors: Beate Hanson and Diarmuid De Faoite
Abstract: There has been a trend toward international multicenter clinical trials in the medical device industry to help increase recruitment figures and to improve the generalizability of results among other factors. However, working globally creates its own unique set of problems which are rarely discussed in the literature. This submission considers these issues from multicenter and multicultural perspectives.
A multicenter study implies a replication of work to coordinate research sites that are working under different regulations. Standardizing elements of the clinical trial is essential to allow proper comparison of results. Multicultural differences manifest themselves in different forms in international clinical research. However, the impact of culture on a study's success is a very real issue, particularly when patient reported outcomes form part of the trial.
Examples from our own clinical investigations are reported throughout this paper.
Keywords: Clinical research; multicultural; multinational perspectives; outcome measures; communication barriers; international cooperation; medical device