COSTA MESA, Calif., Dec. 14, 2012 /PRWeb/ — WCCT Global, LLC, a contract research organization (CRO) supporting Phase I – IV biopharmaceutical and device development, today announced beginning its tenth year as an industry leader in the design, execution and evaluation of Ethnic Bridging Trials for the Global Pharmaceutical Industry. Mel Affrime, Pharm. D., Sr. VP, R&D at WCCT Global said, “The possibility that ethnic differences exist in different populations with regard to metabolism and distribution of drugs has been recognized for years. These differences may be expressed as alterations in safety, efficacy and/or dose, or in terms of adverse event profiles in these ethnically diverse populations. These observations ultimately lead to the publication of ICH E-5 Guidance Document”. WCCT Global has carried out over 60 ethnic bridging trials and recruited over 1200 Asian volunteers since 1993. Kenneth Kim, MD, WCCT Global’s CEO said, “WCCT Global will strive to maintain its industry leadership role in this important area of biopharmaceutical research and development”.
More information on WCCT Global’s Ethnic Bridging Studies History:
In the last 5 years alone, WCCT Global has conducted over 50 ethnic bridging/ Japanese bridging/ Chinese bridging clinical trials. In an interesting WCCT case study, a sponsor conducted a 120 volunteer study with 5 key endpoints: SAD, MAD, food effect, ethnobridging comparison, and monitoring of the primary pharmacodynamic endpoint (platelet aggregation). Such a study was a pivotal part of the development plan for allowing the program to include Japan and the rest of Asia in the global phase III program.
In another landmark ethnic bridging clinical trial, WCCT, as a single site, recruited 26 Japanese, 26 Caucasian, 26 Asian Indian, 26 Korean, 26 Chinese, 26 Filipino, and 26 Vietnamese volunteers for a rosuvastatin study. This study, along with other data generated, resulted in a label change for rosuvastatin stating that Asians, but not Asian Indians, needed to be given half the dose as compared to Caucasians. It is not uncommon to add small cohorts of Korean or Chinese subjects in addition to Japanese subjects to an ethnic bridging trial depending on the company goals for the compound. Results of the trial can be found here: