Reasons for Investigators to Participate Industry Sponsored Clinical Trials

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.

Frequency and Pattern of Hemoglobin Cycling in Korean Hemodialysis Patients Treated with Erythropoiesis Stimulating Agent / 대한신장학회지

PURPOSE: It is frequently observed that the level of hemoglobin (Hb) widely fluctuates during treatment of erythropoiesis stimulating agents (ESAs) in hemodialysis (HD) patients, known as Hb cycling. The purpose of this study was to describe the frequencies and the characteristics of Hb cycling in Korean HD patients treated with ESA. METHODS: Data were analyzed for 49 patients on maintenance HD at our unit between August, 2005 and July, 2006. The patients treated with ESA and oral iron > or =6 months before study period were eligible. Only Hb cycles of duration > or =8 weeks and amplitude >1.5 g/dL were included in the analysis. RESULTS: Forty-seven of patients (96%) had experienced Hb cycling. The mean number of Hb excursions (a half of Hb cycle) was 2.5+/-1.3 times/year/person. The mean amplitude and duration of Hb excursions was 2.4+/-0.7 g/dL and 10.0+/-4.2 weeks, respectively. The mean nadir Hb level of excursions was 9.2+/-0.8 g/dL which was quite lower than 10 g/dL, the lower limit of Hb range recommended in Korea. Down Hb excursions were associated with ESA withdrawal in 78.3%. Patients who were frequent cyclers (> or =2 times/year/person) significantly had a higher prevalence of diabetes mellitus than others (57.1% vs. 28.6%, p=0.047). CONCLUSION: Hb cycling is a common and a serious feature in HD patients treated with ESA. It is primarily a result of anemia treatment practices, especially holding of ESA and, in part, underlying diabetes.

Hemobilia from Pancreatic Arteriovenous Malformation: Successful Treatment with Transportal Coil Embolization of Draining Veins / 대한소화기학회지

Pancreatic arteriovenous malformations (AVM) are extremely rare diseases frequently complicated by gastrointestinal hemorrhage. While surgical resection of affected lesion is preferred for the treatment of pancreatic AVM, angiographic intervention can be used as an alternative treatment, especially in surgically high-risk patients. We experienced a patient with pancreatic AVM manifested by hemobilia and biliary sepsis. Superior mesenteric and common hepatic arteriography showed pancreaticoduodenal AVM composed of nidus supplied by numerous fine feeding arteries and of draining veins encircling the common bile duct (CBD). Hemobilia was controlled by transportal coil embolization of draining veins of AVM around the CBD. Herein, we report this case with the review of literatures.

Safety of Completion Thyroidectomy for Thyroid Cancer

PURPOSE: Completion thyroidectomy is defined as the surgical removal of the remnant thyroid tissue following procedures less than total thyroidectomy. However the roles and indications of completion thyroidectomy remain controversial. This study was performed to review the clinical and pathologic features of patients who underwent completion thyroidectomy and to evaluate the safety of this procedure. METHODS: A retrospective analysis from Nov. 1994 to Dec. 2002 at Samsung Medical Center yielded 36 patients, 11 male and 25 female, who had undergone completion thyroidectomy. Their median follow-up was 29 months. RESULTS: The patients ranged in age from 20 to 58 years. Of the 36 patients, 24 had undergone prophylactic thyroidectomy and 12 therapeutic thyroidectomy for recurrence. The most common cause of completion thyroidectomy was cancers undiagnosed during the primary operation and 12 cases (75%) among these 16 undiagnosed cancers were follicular carcinoma. Three patients harbored carcinoma at the perithyroidal lymph node or remnant thyroid as a result of prophylactic completion thyroidectomy. Postoperative complications occurred in 11 patients (31%): 10 transient hypocalcemia and 1 transient hoarseness. There were no differences in postoperative complication rate between total thyroidectomy group and completion thyroidectomy during the same period at our hospital. CONCLUSION: The most common indication that is considered for completion thyroidectomy is a follicular carcinoma undiagnosed during primary operation. Completion thyroidectomy might be a safe operation with minimal morbidity if it is performed meticulously by an experienced surgeon.

Regrowth of Grafted Lower Half of the Hair Follicle

We have examined the regenerative capabilities of the human scalp hair follicle after grafting the lower half of the follicle. Twenty-eight of 32 intact whole-hair follicles isolated from the human scalp regenerated hairs when grafted onto the forehead of the same person. Seven of the 15 lower-half follicles regenerated complete hair follicles 8 months after grafting showed that the lower-half follicle implant reconstituted the complete hair follicle. The sebaceous gland was not regenerated, but there was an outgrowth in the sebaceous gland regPark ion. Some grafts formed epithelial cysts. Two years after grafting, the histological examination of the regenerated follicle from the lower-half implant showed that the sebaceous gland was completely regenerated. While an intact follicle shows prominent naked shaft outgPark Park Parkrowth, the sheath grows concomitantly with the shaft in lower-half follicles in culture. If grafted lower-half follicles were located too deep, the regrown sheath could not reach the epidermal layer. In this situation, the formation of an epidermal cyst was likely.