Current Status of Clinical Research Coordinator's Employment

BACKGROUND: This study was aimed to investigate the current two years' clinical research coordinators (CRCs) employment and estimate total number of CRCs in Korea. METHODS: The participants were administrative officers or head CRCs in institutions designated by Korea Food & Drug Administration (KFDA). Data on the current status of CRCs' employment was collected with self-administered questionnaires or telephone interview. And total number of CRCs in Korea was estimated based on ratio between the number of the KFDA approved clinical trials and current number of CRCs. RESULTS: The number of CRCs was 1381 at 36 centers in 2009 and 1444 at 37 centers in 2010. About 79 percent of CRCs were employed by investigators. The estimated number of CRCs was from 1677 to 1763 at 135 centers in 2009 and from 1802 to 1890 at 142 centers in 2010 based on number of clinical trials approved by KFDA. Two third of regional clinical trial centers (RCTCs) had written employment policy, and 25 percent of RCTCs employed CRCs in a regular position. All RCTCs had educational programs for CRCs and supported CRCs for training outside. 75 percent of RCTCs provided ID card for CRCs belonging to investigators to access to hospital document. Half of RCTCs had CRC registration system in hospital-wide. CONCLUSION: The number of CRCs in Korea can be easily estimated with the number of KFDA approved clinical trials. Majority of RCTCs still employed CRCs in an irregular position, which should be switched to regular position to reduce the CRCs' unsatisfaction. It is also needed to develop centralized CRC management system for CRCs belonging to investigators.

Pharmacokinetics of ofloxacin in Patients with Multidrug-Resistant Tuberculosis / 결핵

BACKGROUND: There are few studies that have reported on the pharmacokinetic(PK) disposition of fluoroquinolones in patients with multi-drug resistant tuberculosis(MDR-Tb), even though fluoroquinolones are frequentl y co-prescribed to those patients. In this study, the PK disposition of ofloxacin, a fluoroquinolone, was evaluated in patients with MDR-Tb. METHODS: Twenty patients with MDR-Tb were given 2nd line Tb drugs including ofloxacin (300mg twice a day), prothionamide, cycloserine, para-aminosalicylic acid, kanamycin, and streptomycin. The patients were grouped according to their body mass index(BMI) as an index of emaciation (group A: 18.5