Perception on Working Conditions and Utilization of Clinical Research Coordinators among Investigators and Sponsors

BACKGROUND: This study was aimed to investigate the perception on working conditions and utilization of clinical research coordinators (CRCs) among investigators and sponsors. METHODS: The participants of this cross-section study were 114 investigators and 138 sponsors including clinical research associates (CRAs) who have worked with CRCs. Data was collected with paper or electronic form of self-administered questionnaires and analyzed with descriptive statistics and chi2 test or t test. RESULTS: Among investigators and sponsors, 56.1 % and 95.0 % perceived regular full-time positions as proper type of CRC employment, respectively. Those who perceived monthly salary with incentive as proper payment system were 67.5 % of investigators and 68.8 % of sponsors. The proper salary for 2-year CRCs and 5-year CRCs were significantly higher in sponsors than investigators. Investigators perceived CRCs could handle 3 studies as the same time and 5 studies per year. In regard to the difficulty in utilizing CRCs, 68.4 % of investigators perceived lack of experienced CRCs and 84.8 % of sponsors did frequent turnover. Those who responded pooling CRCs by hospital or clinical trial centers as a good solution to hire CRCs easily were 81.6 % of investigators and 58.0 % of sponsors. CONCLUSION: Almost all investigators and sponsors perceived CRCs were helpful for improving the quality of clinical trials. We recommend each institution or clinical trial centers could introduce the central CRCs' employment and management with proper salary and workload based on the results to maintain experienced CRCs and lessen the turnover of CRCs.

3-week-scheduled combination chemotherapy of gemcitabine and cisplatin in patients with advanced NSCLC / 대한내과학회지

BACKGROUND: The combination chemotherapy of gemcitabine and cisplatin has been proven effective in the treatment of advanced non-small cell lung cancer (NSCLC). However, the optimal schedule for administration of the two drugs has not yet been determined. We therefore started a phase II trial to evaluate efficacy, toxicity and dose intensity (DI) as three-week scheduled chemotherapy of gemcitabine and cisplatin. METHODS: Between October 2000 and March 2003, a total of 56 patients with stage IIIB and IV NSCLC were enrolled in this study. Treatment schedule consisted of gemcitabine 1200 mg/m2 i.v. on days 1 and 8, and cisplatin 80 mg/m2 i.v. on day 1 of each chemotherapy cycle followed by two weeks of rest. RESULTS: Forty-eight patients were evaluable in response and adverse effects in this study. The median DI was 529 mg/m2/week for gemcitabine (66%) and 22 mg/m2/week for cisplatin (83%). Partial response was observed in 23 patients. The overall response rate was 47.8% (95% confidence interval [CI], range from 33.6% to 61.9%). Anemia and thrombocytopenia were the main hematologic adverse effects, with 8.3% and 8.3% of patients experiencing grade III to IV toxicity, respectively. The median survival time was 11.78 months (95% CI, range from 8.59 to 14.97months). No significant differences in response rate were observed according to sex, age, histology and DI of gemcitabine and cisplatin. CONCLUSION: The 3-week-scheduled combination chemotherapy of gemcitabine and cisplatin has feasibility to treat advanced stage IIIB and IV NSCLC with modest adverse effects. The regimen deserves further evaluaton in a phase III prospective randomized trial.

A Case of Primary Esophageal Bezoar / 대한소화기내시경학회지

Bezoar is a persistent concretion of indigestible materials, usually found in the stomach, and most cases have been managed by surgical methods. Esophageal bezoars are very rare and have been mainly reported in patients with esophageal motility or anatomical abnormalities. We experienced a case of primary esophageal bezoar dissolved with pancreatic enzyme extracts. A 79-year-old man complained of dysphagia of a 15-day duration. Esophagoscopy revealed a large, yellow-brownish, round, hard mass obstructing the esophageal lumen and a deep ulcer, 30 cm from the incisor teeth. Multiple attempts to break or retrieve it were tried, but failed. He accepted surgical treatment and took a pancreatic enzyme preparation during preoperative evaluation of his heart problem. After 20 days, his symptom was relieved, and bezoar disappeared completely on a follow-up endoscopy. Esophageal manometry disclosed nonspecific esophageal motility disorder.

Endoscopically Removed Granular Cell Tumor of the Esophagus: A Case Report and Review of Korean Literature / 대한소화기내시경학회지

Granular cell tumor is a benign tumor, commonly found in the skin, tongue, and breast but rarely in the esophagus. A 44-year-old man was referred from the private clinic because of an esophageal lesion found on endoscopy. Esophagoscopy revealed a white-yellowish polypoid lesion covered with normal looking mucosa in the upper esophagus. It was movable within the wall by pushing with forceps. Endoscopic polypectomy after ligation with elastic "O" band was performed without complication. Histologic diagnosis of granular cell tumor was made. It was stained strongly positive for S-100 protein. Another 20 cases of esophageal granular cell tumors reported in Korean literature were reviewed.