1.The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group
Bum Jun KIM ; Chi Hoon MAENG ; Bhumsuk KEAM ; Young-Hyuck IM ; Jungsil RO ; Kyung Hae JUNG ; Seock-Ah IM ; Tae Won KIM ; Jae Lyun LEE ; Dae Seog HEO ; Sang-We KIM ; Keunchil PARK ; Myung-Ju AHN ; Byoung Chul CHO ; Hoon-Kyo KIM ; Yoon-Koo KANG ; Jae Yong CHO ; Hwan Jung YUN ; Byung-Ho NAM ; Dae Young ZANG
Cancer Research and Treatment 2025;57(1):39-46
Purpose:
The Korean Cancer Study Group (KCSG) is a nationwide cancer clinical trial group dedicated to advancing investigator-initiated trials (IITs) by conducting and supporting clinical trials. This study aims to review IITs conducted by KCSG and quantitatively evaluate the survival and financial benefits of IITs for patients.
Materials and Methods:
We reviewed IITs conducted by KCSG from 1998 to 2023, analyzing progression-free survival (PFS) and overall survival (OS) gains for participants. PFS and OS benefits were calculated as the difference in median survival times between the intervention and control groups, multiplied by the number of patients in the intervention group. Financial benefits were assessed based on the cost of investigational products provided.
Results:
From 1998 to 2023, KCSG conducted 310 IITs, with 133 completed and published. Of these, 21 were included in the survival analysis. The analysis revealed that 1,951 patients in the intervention groups gained a total of 2,558.4 months (213.2 years) of PFS and 2,501.6 months (208.5 years) of OS, with median gains of 1.31 months in PFS and 1.58 months in OS per patient. When analyzing only statistically significant results, PFS and OS gain per patients was 1.69 months and 3.02 months, respectively. Investigational drug cost analysis from six available IITs indicated that investigational products provided to 252 patients were valued at 10,400,077,294 won (approximately 8,046,481 US dollars), averaging about 41,270,148 won (approximately 31,930 US dollars) per patient.
Conclusion
Our findings, based on analysis of published research, suggest that IITs conducted by KCSG led to survival benefits for participants and, in some studies, may have provided financial benefits by providing investment drugs.
2.The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group
Bum Jun KIM ; Chi Hoon MAENG ; Bhumsuk KEAM ; Young-Hyuck IM ; Jungsil RO ; Kyung Hae JUNG ; Seock-Ah IM ; Tae Won KIM ; Jae Lyun LEE ; Dae Seog HEO ; Sang-We KIM ; Keunchil PARK ; Myung-Ju AHN ; Byoung Chul CHO ; Hoon-Kyo KIM ; Yoon-Koo KANG ; Jae Yong CHO ; Hwan Jung YUN ; Byung-Ho NAM ; Dae Young ZANG
Cancer Research and Treatment 2025;57(1):39-46
Purpose:
The Korean Cancer Study Group (KCSG) is a nationwide cancer clinical trial group dedicated to advancing investigator-initiated trials (IITs) by conducting and supporting clinical trials. This study aims to review IITs conducted by KCSG and quantitatively evaluate the survival and financial benefits of IITs for patients.
Materials and Methods:
We reviewed IITs conducted by KCSG from 1998 to 2023, analyzing progression-free survival (PFS) and overall survival (OS) gains for participants. PFS and OS benefits were calculated as the difference in median survival times between the intervention and control groups, multiplied by the number of patients in the intervention group. Financial benefits were assessed based on the cost of investigational products provided.
Results:
From 1998 to 2023, KCSG conducted 310 IITs, with 133 completed and published. Of these, 21 were included in the survival analysis. The analysis revealed that 1,951 patients in the intervention groups gained a total of 2,558.4 months (213.2 years) of PFS and 2,501.6 months (208.5 years) of OS, with median gains of 1.31 months in PFS and 1.58 months in OS per patient. When analyzing only statistically significant results, PFS and OS gain per patients was 1.69 months and 3.02 months, respectively. Investigational drug cost analysis from six available IITs indicated that investigational products provided to 252 patients were valued at 10,400,077,294 won (approximately 8,046,481 US dollars), averaging about 41,270,148 won (approximately 31,930 US dollars) per patient.
Conclusion
Our findings, based on analysis of published research, suggest that IITs conducted by KCSG led to survival benefits for participants and, in some studies, may have provided financial benefits by providing investment drugs.
3.The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group
Bum Jun KIM ; Chi Hoon MAENG ; Bhumsuk KEAM ; Young-Hyuck IM ; Jungsil RO ; Kyung Hae JUNG ; Seock-Ah IM ; Tae Won KIM ; Jae Lyun LEE ; Dae Seog HEO ; Sang-We KIM ; Keunchil PARK ; Myung-Ju AHN ; Byoung Chul CHO ; Hoon-Kyo KIM ; Yoon-Koo KANG ; Jae Yong CHO ; Hwan Jung YUN ; Byung-Ho NAM ; Dae Young ZANG
Cancer Research and Treatment 2025;57(1):39-46
Purpose:
The Korean Cancer Study Group (KCSG) is a nationwide cancer clinical trial group dedicated to advancing investigator-initiated trials (IITs) by conducting and supporting clinical trials. This study aims to review IITs conducted by KCSG and quantitatively evaluate the survival and financial benefits of IITs for patients.
Materials and Methods:
We reviewed IITs conducted by KCSG from 1998 to 2023, analyzing progression-free survival (PFS) and overall survival (OS) gains for participants. PFS and OS benefits were calculated as the difference in median survival times between the intervention and control groups, multiplied by the number of patients in the intervention group. Financial benefits were assessed based on the cost of investigational products provided.
Results:
From 1998 to 2023, KCSG conducted 310 IITs, with 133 completed and published. Of these, 21 were included in the survival analysis. The analysis revealed that 1,951 patients in the intervention groups gained a total of 2,558.4 months (213.2 years) of PFS and 2,501.6 months (208.5 years) of OS, with median gains of 1.31 months in PFS and 1.58 months in OS per patient. When analyzing only statistically significant results, PFS and OS gain per patients was 1.69 months and 3.02 months, respectively. Investigational drug cost analysis from six available IITs indicated that investigational products provided to 252 patients were valued at 10,400,077,294 won (approximately 8,046,481 US dollars), averaging about 41,270,148 won (approximately 31,930 US dollars) per patient.
Conclusion
Our findings, based on analysis of published research, suggest that IITs conducted by KCSG led to survival benefits for participants and, in some studies, may have provided financial benefits by providing investment drugs.
4.Diagnostic Role of Bile Pigment Components in Biliary Tract Cancer
Keun Soo AHN ; Koo Jeong KANG ; Yong Hoon KIM ; Tae-Seok KIM ; Kwang Bum CHO ; Hye Soon KIM ; Won-Ki BAEK ; Seong-Il SUH ; Jin-Yi HAN
Biomolecules & Therapeutics 2023;31(6):674-681
Bile pigment, bilirubin, and biliverdin concentrations may change as a results of biliary tract cancer (BTC) altering the mechanisms of radical oxidation and heme breakdown. We explored whether changes in bile pigment components could help distinguish BTC from benign biliary illness by evaluating alterations in patients with BTC. We collected bile fluid from 15 patients with a common bile duct stone (CBD group) and 63 individuals with BTC (BTC group). We examined the bile fluid’s bilirubin, biliverdin reductase (BVR), heme oxygenase (HO-1), and bacterial taxonomic abundance. Serum bilirubin levels had no impact on the amounts of bile HO-1, BVR, or bilirubin. In comparison to the control group, the BTC group had considerably higher amounts of HO-1, BVR, and bilirubin in the bile. The areas under the curve for the receiver operating characteristic curve analyses of the BVR and HO-1 were 0.832 (p<0.001) and 0.891 (p<0.001), respectively. Firmicutes was the most prevalent phylum in both CBD and BTC, according to a taxonomic abundance analysis, however the Firmicutes/Bacteroidetes ratio was substantially greater in the BTC group than in the CBD group. The findings of this study showed that, regardless of the existence of obstructive jaundice, biliary carcinogenesis impacts heme degradation and bile pigmentation, and that the bile pigment components HO-1, BVR, and bilirubin in bile fluid have a diagnostic significance in BTC. In tissue biopsies for the diagnosis of BTC, particularly for distinguishing BTC from benign biliary strictures, bile pigment components can be used as additional biomarkers.
5.Postoperative mortality in patients with end-stage renal disease according to the use of sugammadex: a single-center retrospective propensity score matched study
Sanghoon SONG ; Ho Bum CHO ; Sun Young PARK ; Wan Mo KOO ; Sang Jin CHOI ; Sokyung YOON ; Suyeon PARK ; Jae Hwa YOO ; Mun Gyu KIM ; Ji Won CHUNG ; Sang Ho KIM
Anesthesia and Pain Medicine 2022;17(4):371-380
Methods:
We retrospectively collected the medical records of 2,134 patients with end-stage renal disease who were dependent on hemodialysis and underwent surgery under general anesthesia between January 2018 and December 2019. Propensity score matching was used. The primary outcome was the 30-day mortality rate, and secondary outcomes were the 1-year mortality rate and causes of death.
Results:
A total of 2,039 patients were included in the study. Sugammadex was administered as a reversal agent for rocuronium in 806 (39.5%) patients; the remaining 1,233 (60.5%) patients did not receive sugammadex. After matching, 1,594 patients were analyzed; 28 (3.5%) of the 797 patients administered sugammadex, and 28 (3.5%) of the 797 patients without sugammadex, died within 30 days after surgery (P > 0.99); 38 (4.8%) of the 797 patients administered sugammadex, and 45 (5.7%) of the 797 patients without sugammadex, died within 1 year after surgery (P = 0.499). No significant differences in the causes of 30-day mortality were observed between the two groups after matching (P = 0.860).
Conclusions
In this retrospective study, sugammadex did not increase the 30-day and 1-year mortality rate after surgery in end-stage renal disease patients.
6.Recent Surgical Outcomes ofCongenital Heart Disease according toKorea Heart Foundation Data
Hong Ju SHIN ; Young Hwan PARK ; Bum-Koo CHO
Korean Circulation Journal 2020;50(8):677-690
Background and Objectives:
This study presents an update of the surgical outcomes ofcongenital heart disease (CHD) according to Korea Heart Foundation (KHF) data.
Methods:
We investigated the data of the 7,305 patients who were economically supportedby KHF in 2000–2014. Of them, we analyzed surgical outcomes of the 6,599 patients whounderwent CHD surgery.
Results:
The median patient age was 1.9 years (range, 0–71.5 years). Of the 6,599 patients,5,616 (85.1%) underwent biventricular repair and 983 (14.9%) underwent palliativeprocedures. The mean Basic Aristotle Score was 6.6±2.2. A complex procedure (definedas Basic Aristotle Score above 6) was performed in 3,368 patients (51.0%). The earlymortality rate was 3.8%, while the late mortality rate was 1.8%. Previous reports of the KHF(1984–1999) showed that the early surgical and late mortality rates were 8.6%, and 5.3%,respectively. There were 491 neonates (7.4%); among them, the early mortality rate was 12.2%and late mortality rate was 3.7%. There were 2,617 infants (40.0%); among them, the earlymortality rate was 6.0% and the late mortality rate was 2.3%. A total of 591 patients from 30countries were helped by the KHF.
Conclusions
More neonatal surgeries (491 vs. 74 patients) were performed than those inthe past (1984–1999). The surgical outcomes were much better than before. Our surgicaloutcomes revealed that the Republic of Korea has been transformed from a country receivinghelp to a country that helps other low socioeconomic status countries.
7.Analysis of Asian Mitochondrial DNA Haplogroups Associated With the Progression of Knee Osteoarthritis in Koreans
Bon San KOO ; Yoonah SONG ; Seunghun LEE ; Yoon-Kyoung SUNG ; Kyoung-Jin SHIN ; Nam H. CHO ; Jae-Bum JUN
Journal of Rheumatic Diseases 2020;27(3):168-173
Objective:
. We investigated Asian mitochondrial DNA (mtDNA) haplogroups associated with knee osteoarthritis (OA) progression in a prospective community-based cohort comprised of Koreans.
Methods:
. Epidemiologic data and Kellgren-Lawrence (K/L) scores of knee radiographs were obtained from the second (2005∼2006) and sixth (2013∼2014) follow-up, and patient DNA was analyzed. The mtDNA haplogroup frequencies (M, G, D, D4, D5, M7, M8, M9, M10, N, A, N9, R, F, and B) were compared between the progression (K/L score change on either knee ≥2 or arthroplasty) and non-progression (K/L score change on both knee ≤1) groups at the sixth follow-up. Multiple logistic regression was performed to determine relative risk (RRs) of mtDNA haplogroups for OA.
Results:
. In total, 1,115 participants were included, 405 of whom had early OA (higher K/L score on both knees of 1 or 2). Among them, 143 and 166 patients were classified in non-progression and progression groups, respectively, at the sixth follow-up. The most frequent haplogroups, B and D4, in Koreans also showed a high frequency in our study. There were no significantly different haplogroups between the non-progression and progression groups. However, the frequency of haplogroup D4 was likely higher in the non-progression group than in the progression group, although not significantly (13.3% vs. 7.2%, RR=0.51, p=0.081 in the unadjusted model and RR=0.56, p=0.149 in the adjusted model).
Conclusion
. No significant haplogroups are related to OA progression. Large-scaled studies are needed to reveal the association between mtDNA haplogroups and OA.
8.Cigarette Smoking Preferentially Affects Intracranial Vessels in Young Males: A Propensity-Score Matching Analysis
Yunsun SONG ; Dongwhane LEE ; Dae Chul SUH ; Joong goo KIM ; Jae Kyun KIM ; Minkyu HAN ; Hairi LIU ; Lingbo ZHAO ; Eun Hye KIM ; Sung Chul JUNG ; Dong geun LEE ; Hyun Jung KOO ; Min ju KIM ; Seunghee BAEK ; Seon Moon HWANG ; Bum Joon KIM ; Yeon Jung KIM ; Hong Jun CHO ; Sang Joon KIM ; Sang Beom JEON ; Jong S KIM
Neurointervention 2019;14(1):43-52
PURPOSE: Cigarette smoking (CS) is one of the major risk factors of cerebral atherosclerotic disease, however, its level of contribution to extracranial and intracranial atherosclerotic stenosis (ECAS and ICAS) was not fully revealed yet. The purpose of our study was to assess the association of CS to cerebral atherosclerosis along with other risk factors. MATERIALS AND METHODS: All consecutive patients who were angiographically confirmed with severe symptomatic cerebral atherosclerotic disease between January 2002 and December 2012 were included in this study. Multivariate logistic regression analyses were performed to identify risk factors for ECAS and ICAS. Thereafter, CS group were compared to non-CS group in the entire study population and in a propensity-score matched population with two different age-subgroups. RESULTS: Of 1709 enrolled patients, 794 (46.5%) had extracranial (EC) lesions and the other 915 (53.5%) had intracranial (IC) lesions. CS group had more EC lesions (55.8% vs. 35.3%, P<0.001) whereas young age group (<50 years) had more IC lesion (84.5% vs. 47.6%, P<0.001). In multivariate analysis, seven variables including CS, male, old age, coronary heart disease, higher erythrocyte sedimentation rate, multiple lesions, and anterior lesion were independently associated with ECAS. In the propensity-score matched CS group had significant more EC lesion compared to non-CS group (65.7% vs. 47.9%) only in the old age subgroup. CONCLUSION: In contrast to a significant association between CS and severe symptomatic ECAS shown in old population, young patients did not show this association and showed relatively higher preference of ICAS.
Atherosclerosis
;
Blood Sedimentation
;
Cerebrovascular Circulation
;
Constriction, Pathologic
;
Coronary Disease
;
Humans
;
Intracranial Arteriosclerosis
;
Logistic Models
;
Male
;
Multivariate Analysis
;
Risk Factors
;
Smoking
;
Tobacco Products
9.Chronic Hepatitis B Infection Is Significantly Associated with Chronic Kidney Disease: a Population-based, Matched Case-control Study.
Sung Eun KIM ; Eun Sun JANG ; Moran KI ; Geum Youn GWAK ; Kyung Ah KIM ; Gi Ae KIM ; Do Young KIM ; Dong Joon KIM ; Man Woo KIM ; Yun Soo KIM ; Young Seok KIM ; In Hee KIM ; Chang Wook KIM ; Ho Dong KIM ; Hyung Joon KIM ; Neung Hwa PARK ; Soon Koo BAIK ; Jeong Ill SUH ; Byung Cheol SONG ; Il Han SONG ; Jong Eun YEON ; Byung Seok LEE ; Youn Jae LEE ; Young Kul JUNG ; Woo Jin CHUNG ; Sung Bum CHO ; Eun Young CHO ; Hyun Chin CHO ; Gab Jin CHEON ; Hee Bok CHAE ; DaeHee CHOI ; Sung Kyu CHOI ; Hwa Young CHOI ; Won Young TAK ; Jeong HEO ; Sook Hyang JEONG
Journal of Korean Medical Science 2018;33(42):e264-
BACKGROUND: Hepatitis B virus (HBV) infection leads to hepatic and extrahepatic manifestations including chronic kidney disease (CKD). However, the association between HBV and CKD is not clear. This study investigated the association between chronic HBV infection and CKD in a nationwide multicenter study. METHODS: A total of 265,086 subjects who underwent health-check examinations in 33 hospitals from January 2015 to December 2015 were enrolled. HBV surface antigen (HBsAg) positive cases (n = 10,048), and age- and gender-matched HBsAg negative controls (n = 40,192) were identified. CKD was defined as a glomerular filtration rate (GFR) < 60 mL/min/1.73 m² or proteinuria as at least grade 2+ of urine protein. RESULTS: HBsAg positive cases showed a significantly higher prevalence of GFR < 60 mL/min/1.73 m² (3.3%), and proteinuria (18.9%) than that of the controls (2.6%, P < 0.001, and 14.1%, P < 0.001, respectively). In the multivariate analysis, HBsAg positivity was an independent factor associated with GFR < 60 mL/min/1.73 m² along with age, blood levels of albumin, bilirubin, anemia, and hemoglobin A1c (HbA1c). Likewise, HBsAg positivity was an independent factor for proteinuria along with age, male, blood levels of bilirubin, protein, albumin, and HbA1c. A subgroup analysis showed that HBsAg positive men but not women had a significantly increased risk for GFR < 60 mL/min/1.73 m². CONCLUSION: Chronic HBV infection was significantly associated with a GFR < 60 mL/min/1.73 m² and proteinuria (≥ 2+). Therefore, clinical concern about CKD in chronic HBV infected patients, especially in male, is warranted.
Anemia
;
Antigens, Surface
;
Bilirubin
;
Case-Control Studies*
;
Female
;
Glomerular Filtration Rate
;
Hepatitis B Surface Antigens
;
Hepatitis B virus
;
Hepatitis B, Chronic*
;
Hepatitis, Chronic*
;
Humans
;
Male
;
Multivariate Analysis
;
Prevalence
;
Proteinuria
;
Renal Insufficiency, Chronic*
10.The virtual asthma guideline e-learning program: learning effectiveness and user satisfaction.
Sung Yoon KANG ; Sae Hoon KIM ; Yong Eun KWON ; Tae Bum KIM ; Hye Kyung PARK ; Heung Woo PARK ; Yoon Seok CHANG ; Young Koo JEE ; Hee Bom MOON ; Kyung Up MIN ; Sang Heon CHO
The Korean Journal of Internal Medicine 2018;33(3):604-611
BACKGROUND/AIMS: Effective educational tools are important for increasing adherence to asthma guidelines and clinical improvement of asthma patients. We developed a computer-based interactive education program for asthma guideline named the Virtual Learning Center for Asthma Management (VLCAM). We evaluated the usefulness of program in terms of its effects on user awareness of asthma guideline and level of satisfaction. METHODS: Physicians-in-training at tertiary hospitals in Korea were enrolled in a cross-sectional questionnaire survey. The e-learning program on asthma guideline was conducted over a 2-week period. We investigated changes in the awareness of asthma guideline using 35-item self-administered questionnaire aiming at assessing physicians' knowledge, attitude, and practice. Satisfaction with the program was scored on 4-point Likert scales. RESULTS: A total of 158 physicians-in-training at six tertiary hospitals completed the survey. Compared with baseline, the overall awareness obtained from the scores of knowledge, attitude, and practice was improved significantly. Participants were satisfied with the VLCAM program in the following aspects: helpfulness, convenience, motivation, effectiveness, physicians' confidence, improvement of asthma management, and willingness to recommend. All items in user satisfaction questionnaires received high scores over 3 points. Moreover, the problem-based learning with a virtual patient received the highest user satisfaction among all parts of the program. CONCLUSIONS: Our computer-based e-learning program is useful for improving awareness of asthma management. It could improve adherence to asthma guidelines and enhance the quality of asthma care.
Asthma*
;
Education
;
Humans
;
Korea
;
Learning*
;
Motivation
;
Problem-Based Learning
;
Tertiary Care Centers
;
Weights and Measures

Result Analysis
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