As Korea has increasing number of clinical trials in recent years, institutional review boards (IRBs) are facing new challenges. The IRB should review submitted documents and supervise clinical trials from the beginning to the end to protect human subjects. Although most IRBs invest much time and efforts to initial review, they rarely conduct proper continuing management at the moment. The purpose of this article is to describe challenges involving continuing management, which includes unanticipated problems, subject's complaints, site visit, and continuing review, and to provide suggestions for improving it. Above all, institutions should perceive the importance of continuing management and they should provide sufficient manpower and resources for the management.

Background: It is getting more difficult to involve appropriate investigators in clinical trials. Knowing what investigators want from sponsor initiated clinical trials would help industry cooperate with investigators more efficiently. This study aims to describe the incentives for investigators choosing to participate or not and perform well in sponsored clinical trials. Methods: Investigators who have participated in GSK sponsored clinical trials were interviewed face-to-face or through e-mail using the standardized questionnaire. Investigators were asked to choose five items and determine the ranking or those five items Results: Questionnaires answered by 122 investigators were collected. The top three incentives were "Academic merit" (108, 88.5 %), "Expectation of treatment potentially helpful to patient" (101, 82.8 %), and "Access to new treatments" (92, 75.4 %). The disincentives and the factors affecting an investigator's performance were analyzed separately because of the different questionnaire between investigators for medicine and vaccine. Investigators for medicine choose as disincentives "Insufficient time" (43, 61.4 %), "Difficult protocol" (41, 58.6 %), and "Adverse event concerns" (41, 58.6 %). Vaccine investigators pointed out "Limited support staff" (41, 78.8 %), "Insufficient time" (40, 76.9 %), and "Difficult blood sampling" (333, 63.5 %) as disincentives. Factors adversely affecting an investigator's performance showed similar results to those of disincentives. Conclusion: Investigators focused on academic curiosity and patients and insufficient time mostly inhibits them from participating and performing clinical trials. Our results would help industry cooperate with investigators more efficiently, finally making companies perform clinical trials more effectively.

Background: This study was aimed to investigate recognition of clinical research coordinators (CRCs) among non-nursing major students. Methods: The participants were 424 undergraduate or graduate students whose majors were related to life science, physical therapy or pharmaceutical engineering in three universities located in Busan. Data were collected with self administrated questionnaire including general characteristics (5 items), and recognition of CRCs (4 items). The collected data were coded and was analyzed using SPSS Version 18.0 for Windows for frequency and percentage, or mean and standard deviation. The Chi-squared test was used to assess the relationship between general characteristics and recognition of CRCs. All statistical tests were performed at the 0.05 level of significance for two-tailed tests. Results: The percent of 'ever having heard of CRCs' was 28.3 % and 35.0 % of them showed the intention to work as CRCs. The 'ever having heard of CRCs' was related to major (p<0.001) and 'ever having heard of clinical trials' (p<0.001). The intention to work as CRCs was not related to gender, education, major, and 'ever having heard of clinical trials'. Conclusion: The level of 'ever having heard of CRCs' among non-nursing major students was lower than that of nurses. It is needed that more active introduction or promotion of CRCs to non-nursing major students through both regular curriculum or training programs. And it is also recommended to develop the job description for CRCs with nurse license or CRCs without nurse license.

Background: Risperidone is one of the atypical antipsychotic drugs that have effectiveness in the management of a range of psychiatric illnesses. Orally disintegrating (OD) formulations of risperidone that rapidly dissolve in the mouth, prior to swallowing without water have been developed to overcome any problems related to swallowing and improve acceptability. The goal of this study was to evaluate the bioequivalence of Risperdal OD$^{(R)}$ tablet 1mg and Quicklet$^{(R)}$ tablet 1mg Methods: This randomized, open-label, 2-way crossover trial was conducted in 36 healthy male volunteers that received OD risperidone tablet, either the reference formulation (Risperdal Quicklet$^{(R)}$tablet 1mg), or the test formulation (Risperdal OD$^{(R)}$ tablet 1mg), each in a single administration. Blood samples were obtained during a 24-hour period after dosing. Plasma was analyzed for risperidone by a validated LC-MS/MS. Adverse events were monitored by safety assessments including clinical interview by clinician. Pharmacokinetics were calculated by noncompartmental analysis and compared between two formulations Results: A total of 36 male volunteers (mean age, 24.2 years; height 174.5 cm; weight 67.6 kg) completed the study. The ANOVA showed no significant effect of sequence, formulation and period of Ln ($AUC_{last}$) and Ln ($C_{max}$). The 90 % confidence intervals for the mean treatment ratios of the Ln (AUClast) and Ln ($C_{max}$) were Ln 0.96 ~ Ln 1.12, Ln 0.97 ~ Ln 1.16, respectively. No serious adverse events were caused by both formulations. Conclusion: In this study, a single administration of Risperdal OD$^{(R)}$ tablet 1mg was bioequivalent to a single administration of Risperdal Quicklet$^{(R)}$ tablet 1mg.

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.

배경: 일상 식이 생활에서 흔히 쓰이는 생강(ginger)의 한 성분인 6-gingerol은 질병 치료 과정 중에 사용하는 약물과 상호 작용을 일으킬 수 있다. 그러나 인체 간 대사 효소인 시토크롬 P450 활성도에 대한 6-gingerol의 효과는 아직 알려져 있지 않다. 본 연구에서는 인체 간 미세소체에서 6-gingerol이 시토크롬 P450대사 효소에 미치는 억제 효과를 연구하고자 하였다. 방법: 인체 간 미세소체 모델을 이용하여 다양한 농도의 6-gingerol과 각각의 CYP450에 특이적인 기질을 함께 배양하였으며, 각각의 대사물을 HPLC로 측정하였다. 본 연구에서 사용된 CYP효소에 의해 촉매 되는 반응에는 CYP1A2에 의한 phenacetin O-deethylation, CYP2C9에 의한 tolbutamide 4-hydroxyltion, CYP2C19에 의한 S-mephenytoin 4'-hydroxylation, CYP2D6에 의한 dextromethorphan O-demethylation, CYP2E1에 의한 chlorzoxazone 6-hydroxylation, 그리고 CYP3A4에 의한 midazolam 1-hydroxylation이었다. 결과: 6-gingerol은 $IC_{50}$가 $100{\mu}M$을 상회할 정도로 CYP2C9, CYP2D6, CYP2E1 그리고 CYP3A4의 활성도에 큰 영향을 미치지 않았다. 그러나 6-gingerol은 CYP 2C19과 CYP 1A2에 대하여 Ki 수치가 각각 $13{\mu}M$과 $29{\mu}M$이 될 정도로 강한 억제 효과를 나타내었다. CYP1A2에 대하여 6-gingerol은 상경적인 형태의 억제를 초래하였다. 결론: 이러한 결과는 6-gingerol이 CYP1A2과 CYP2C19의 활성도를 잠재적으로 억제할 수 있음을 시사하였다.