| Mark P Wade at Lionbridge Technologies argues that good translation should be high on the list of priorities when designing a clinical trial abroad
A cursory review of the agenda from the March 2007 DIA Annual EuroMeeting in Vienna, the agenda of the Annual Meeting in June in Atlanta, and almost every publication focused on the pharmaceutical industries, reveal that clinical trials have truly gone global. There is no longer any debate about when or if trials should be conducted globally – it is now accepted business. To meet the demand for global trials, each region is touting the key benefits of conducting business there, typically centred on the speed that appropriate patient populations can be recruited.
According to an April 2007 article posted on Clinical Trials Today, the number of patients participating in clinical trials in Russia tripled between 2001 and 2006. This growth is attributed to a large population of treatment-naïve patients with centralised healthcare, and improvements in other key areas such as a streamline regulatory system and physicians who are eager to conduct clinical trials (1). This experience is replicated in other emerging markets, such as India and China.
Regulators are now demanding increasingly deep population pools, longer term monitoring and more trials. Access to large drug-naïve populations, lower operating costs of running the trials, and the ability to rapidly recruit suitable participants are pushing these boundaries farther and farther across the globe into the so-called ascending markets of Eastern Europe, Asia and Latin America.
Further, according to Thomson CenterWatch, with nearly half of European and US sites indicating that patient recruitment and enrolment is a key factor in programme delays, 20 to 30 per cent of clinical trials are being conducted in ascending regions (2). Conducting a trial on a global scale introduces significant management challenges, many of which can be attributed to simple communication. |
