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.Is Clostridium difficile infection a real threat in patients with ulcerative colitis? A prospective, multicenter study in Korea.
Dae Bum KIM ; Kang Moon LEE ; Sang Hyoung PARK ; You Sun KIM ; Eun Soo KIM ; Jun LEE ; Sung Ae JUNG ; Geom Seog SEO ; Ji Min LEE
Intestinal Research 2018;16(2):267-272
BACKGROUND/AIMS: Clostridium difficile infection (CDI) has been reported to be a cause of flare-ups in patients with ulcerative colitis (UC). We evaluated the prevalence and clinical outcomes of CDI in patients with UC hospitalized for flare-ups. METHODS: This was a prospective, multicenter study including 7 academic teaching hospitals in Korea. All consecutive patients with UC admitted for disease flare-up were enrolled. We detected the presence of CDI by using enzyme immunoassay, real-time polymerase chain reaction (RT-PCR) for toxin genes, and sigmoidoscopy. RESULTS: Eighty-one consecutive patients with UC were enrolled from January 2014 to December 2015. Among 81 patients, 8 (9.9%) were diagnosed with CDI. Most of the cases were identified by RT-PCR. Enzyme immunoassay was positive in 3 of 8 patients, and only 1 had typical endoscopic findings of pseudomembranous colitis. There were no differences in demographic data, length of hospital stay, or colectomy rate between patients with and without CDI. CONCLUSIONS: CDI was not a rare cause of flare-up in patients with UC in Korea. However, CDI did not appear to affect the course of UC flare-up in Korean patients. RT-PCR was sensitive in detecting CDI and can be considered a diagnostic tool in patients with UC flare-up.
Clostridium difficile*
;
Clostridium Infections
;
Clostridium*
;
Colectomy
;
Colitis, Ulcerative*
;
Enterocolitis, Pseudomembranous
;
Hospitals, Teaching
;
Humans
;
Immunoenzyme Techniques
;
Korea*
;
Length of Stay
;
Polymerase Chain Reaction
;
Prevalence
;
Prospective Studies*
;
Real-Time Polymerase Chain Reaction
;
Sigmoidoscopy
;
Ulcer*
5.Endoscopic Electrosurgery in Patients with Cardiac Implantable Electronic Devices.
Myong Ki BAEG ; Sang Woo KIM ; Sun Hye KO ; Yoon Bum LEE ; Seawon HWANG ; Bong Woo LEE ; Hye Jin CHOI ; Jae Myung PARK ; In Seok LEE ; Yong Seog OH ; Myung Gyu CHOI
Clinical Endoscopy 2016;49(2):176-181
BACKGROUND/AIMS: Patients with cardiac implantable electronic devices (CIEDs) undergoing endoscopic electrosurgery (EE) are at a risk of electromagnetic interference (EMI). We aimed to analyze the effects of EE in CIED patients. METHODS: Patients with CIED who underwent EE procedures such as snare polypectomy, endoscopic submucosal dissection (ESD), and endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy (EST) were retrospectively analyzed. Postprocedural symptoms as well as demographic and outpatient follow-up data were reviewed through medical records. Electrical data, including preprocedural and postprocedural arrhythmia records, were reviewed through pacemaker interrogation, 24-hour Holter monitoring, or electrocardiogram. RESULTS: Fifty-nine procedures in 49 patients were analyzed. Fifty procedures were performed in 43 patients with a pacemaker, and nine were performed in six patients with an implantable cardioverter-defibrillator. There were one gastric and 44 colon snare polypectomies, five gastric and one colon ESDs, and eight ERCPs with EST. Fifty-five cases of electrical follow-up were noted, with two postprocedural changes not caused by EE. Thirty-one pacemaker interrogations had procedure recordings, with two cases of asymptomatic tachycardia. All patients were asymptomatic with no adverse events. CONCLUSIONS: Our study reports no adverse events from EE in patients with CIED, suggesting that this procedure is safe. However, because of the possibility of EMI, recommendations on EE should be followed.
Arrhythmias, Cardiac
;
Cholangiopancreatography, Endoscopic Retrograde
;
Colon
;
Defibrillators, Implantable
;
Electrocardiography
;
Electrocardiography, Ambulatory
;
Electrosurgery*
;
Follow-Up Studies
;
Humans
;
Magnets
;
Medical Records
;
Outpatients
;
Retrospective Studies
;
SNARE Proteins
;
Sphincterotomy, Endoscopic
;
Tachycardia
6.Additive Beneficial Effects of Valsartan Combined with Rosuvastatin in the Treatment of Hypercholesterolemic Hypertensive Patients.
Ji Yong JANG ; Sang Hak LEE ; Byung Soo KIM ; Hong Seog SEO ; Woo Shik KIM ; Youngkeun AHN ; Nae Hee LEE ; Kwang Kon KOH ; Tae Soo KANG ; Sang Ho JO ; Bum Kee HONG ; Jang Ho BAE ; Hyoung Mo YANG ; Kwang Soo CHA ; Bum Soo KIM ; Choong Hwan KWAK ; Deok Kyu CHO ; Ung KIM ; Joo Hee ZO ; Duk Hyun KANG ; Wook Bum PYUN ; Kook Jin CHUN ; June NAMGUNG ; Tae Joon CHA ; Jae Hyeon JUHN ; Yeili JUNG ; Yangsoo JANG
Korean Circulation Journal 2015;45(3):225-233
BACKGROUND AND OBJECTIVES: We compared the efficacy and safety of valsartan and rosuvastatin combination therapy with each treatment alone in hypercholesterolemic hypertensive patients. SUBJECTS AND METHODS: Patients who met inclusion criteria were randomized to receive 1 of the following 2-month drug regimens: valsartan 160 mg plus rosuvastatin 20 mg, valsartan 160 mg plus placebo, or rosuvastatin 20 mg plus placebo. The primary efficacy variables were change in sitting diastolic blood pressure (sitDBP) and sitting systolic blood pressure (sitSBP), and percentage change in low-density lipoprotein-cholesterol (LDL-C) in the combination, valsartan, and rosuvastatin groups. Adverse events (AEs) during the study were analyzed. RESULTS: A total of 354 patients were screened and 123 of them were finally randomized. Changes of sitDBP by least squares mean (LSM) were -11.1, -7.2, and -3.6 mm Hg, respectively, and was greater in the combination, as compared to both valsartan (p=0.02) and rosuvastatin (p<0.001). Changes of sitSBP by LSM were -13.2, -10.8, and -4.9 mm Hg, and was greater in the combination, as compared to rosuvastatin (p=0.006) and not valsartan (p=0.42). Percentage changes of LDL-C by LSM were -52, -4, and -47% in each group, and was greater in the combination, as compared to valsartan (p<0.001), similar to rosuvastatin (p=0.16). Most AEs were mild and resolved by the end of the study. CONCLUSION: Combination treatment with valsartan and rosuvastatin exhibited an additive blood pressure-lowering effect with acceptable tolerability, as compared to valsartan monotherapy. Its lipid lowering effect was similar to rosuvatatin monotherapy.
Blood Pressure
;
Drug Therapy, Combination
;
Humans
;
Least-Squares Analysis
;
Rosuvastatin Calcium
;
Valsartan
7.Erratum to: Additive Beneficial Effects of Valsartan Combined with Rosuvastatin in the Treatment of Hypercholesterolemic Hypertensive Patients.
Ji Yong JANG ; Sang Hak LEE ; Byung Soo KIM ; Hong Seog SEO ; Woo Shik KIM ; Youngkeun AHN ; Nae Hee LEE ; Kwang Kon KOH ; Tae Soo KANG ; Sang Ho JO ; Bum Kee HONG ; Jang Ho BAE ; Hyoung Mo YANG ; Kwang Soo CHA ; Bum Soo KIM ; Choong Hwan KWAK ; Deok Kyu CHO ; Ung KIM ; Joo Hee ZO ; Duk Hyun KANG ; Wook Bum PYUN ; Kook Jin CHUN ; June NAMGUNG ; Tae Joon CHA ; Jae Hyeon JUHN ; YeiLi JUNG ; Yangsoo JANG
Korean Circulation Journal 2015;45(4):349-349
In this article, on page 230, Fig. 2A needs to be corrected.
8.Smart-Phone Addiction, Depression/Anxiety, and Self-Esteem with Attention-Deficit Hyperactivity Disorder in Korean Children.
Hyo Chul LEE ; Min Ha HONG ; Chang Keun OH ; Se Hoon SHIM ; Yeon Joo JUN ; Seog Bum LEE ; Kyung Kyu LEE ; Ki Chung PAIK ; Hea Soon BAEK ; Myung Ho LIM
Journal of the Korean Academy of Child and Adolescent Psychiatry 2015;26(3):159-164
OBJECTIVES: The current study investigated the risk of smartphone addiction among children and adolescents with or without attention-deficit hyperactivity disorder (ADHD), risk of depression, anxiety, and self-esteem using the Smartphone Addiction Scale Proneness, Kovac's Children's Depression Inventory, State-Trait Anxiety Inventory, and Rosenberg Self-Esteem Scale, commonly used in clinical medicine. METHODS: Ninety five students with ADHD who visited psychiatry outpatient clinics completed the questionnaire. At the same time, 592 middle and high school students living in a similar area regardless of ADHD diagnosis, completed the questionnaire as control subjects. RESULTS: Overall, 40.0% of 95 ADHD and 12.8% of 592 control subjects were classified as the smartphone addiction proneness group, 26.3% of the ADHD subjects and 8.3% of the control group were classified as the depression group, and 32.6% of the ADHD subjects and 16.2% of the control group were classified as the anxiety group. Significant differences were observed between the two groups. CONCLUSION: The results of this study suggest that ADHD subjects are more prone to smartphone addiction, becoming depressed or anxious than those in the control group. From this study, we could suggest that students with ADHD are more easily affected by smartphone addiction than normal control subjects. In addition, we might understand how some psychiatric problems like depression, anxiety, and low self-esteem are related to ADHD and smartphone addiction.
Adolescent
;
Ambulatory Care Facilities
;
Anxiety
;
Child*
;
Clinical Medicine
;
Depression
;
Diagnosis
;
Humans
;
Smartphone
9.Multicenter Study on the Clinician's Diagnostic and Therapeutic Approaches for Benign Paroxysmal Positional Vertigo in Korea
Eun Ju JEON ; Won Ho CHUNG ; Jeong Hwan CHOI ; Eui Cheol NAM ; Hong Ju PARK ; Jong Dae LEE ; Won Sang LEE ; Kyu Sung KIM ; Eui Kyung GOH ; Ja Won KOO ; Min Bum KIM ; Min Beom KIM ; Se Hyung KIM ; Young Jin KIM ; Chang Hee KIM ; Sung Il NAM ; Seog Kyun MUN ; Ga Young PARK ; Sang Yoo PARK ; Shi Nae PARK ; Chang Hoon BAE ; Sung Hyun BOO ; Myung Whan SUH ; Jae Hyun SEO ; Eun Jin SON ; Jae Jun SONG ; Jae Jin SONG ; Joong Wook SHIN ; Dae Bo SHIM ; Seong Ki AHN ; Hye Youn YOUM ; Shin Young YOO ; Dong Hee LEE ; Seung Hwan LEE ; Chang Ho LEE ; Hyun Seok LEE ; Hwan Ho LEE ; Hyo Jeong LEE ; Yun Hoon CHOUNG ; Seung Hyo CHOI ; Jee Sun CHOI ; Seok Min HONG ; Sung Kwang HONG
Journal of the Korean Balance Society 2013;12(3):79-92
BACKGROUND AND OBJECTIVES: It is necessary to establish the most efficient diagnostic and therapeutic method for benign paroxysmal positional vertigo (BPPV), which is appropriate for Korean healthcare system. We aimed to evaluate current state of Korean clinician's diagnostic and therapeutic approaches for BPPV. MATERIALS AND METHODS: A 16-item survey was emailed to the members of dizziness department of Otology Research Interest Group in the Korean Otologic Society (n=68). 43 were returned and analyzed. RESULTS: All respondents (100%) used Dix-Hallpike test as a diagnostic tool for vertical canal-BPPV. Supine roll test was used for diagnosing lateral canal BPPV in nearly all the respondents (97.7%). Epley maneuver was chosen as otolith repositioning maneuver (ORM) for posterior canal BPPV in all respondents and barbecue rotation (BBQ) was used for treating lateral canal BPPV with geotropic nystagmus in 95.3% of respondents. Extreme variation was noted for therapeutic approach of lateral canal BPPV with ageotropic nystagmus BBQ, with 4 kinds of ORM and adjunctive measures to liberate otolith from cupula, while BBQ was again the most commonly used ORM (76.7%). CONCLUSION: The development of practical and efficient ORM for lateral canal BPPV with ageotropic nystagmus is necessary.
Surveys and Questionnaires
;
Delivery of Health Care
;
Dizziness
;
Electronic Mail
;
Korea
;
Otolaryngology
;
Otolithic Membrane
;
Public Opinion
;
Vertigo
10.Current Status of Laparoscopic Liver Resection in Korea.
Joon Seong PARK ; Ho Seong HAN ; Dae Wook HWANG ; Yoo Seok YOON ; Jai Young CHO ; Yang Seok KOH ; Choon Hyuck David KWON ; Kyung Sik KIM ; Sang Bum KIM ; Young Hoon KIM ; Hyung Chul KIM ; Chong Woo CHU ; Dong Shik LEE ; Hong Jin KIM ; Sang Jae PARK ; Sung Sik HAN ; Tae Jin SONG ; Young Joon AHN ; Yung Kyung YOO ; Hee Chul YU ; Dong Sup YOON ; Min Koo LEE ; Hyeon Kook LEE ; Seog Ki MIN ; Chi Young JEONG ; Soon Chan HONG ; In Seok CHOI ; Kyung Yul HUR
Journal of Korean Medical Science 2012;27(7):767-771
Since laparoscopic liver resection was first introduced in 2001, Korean surgeons have chosen a laparoscopic procedure as one of the treatment options for benign or malignant liver disease. We distributed and analyzed a nationwide questionnaire to members of the Korean Laparoscopic Liver Surgery Study Group (KLLSG) in order to evaluate the current status of laparoscopic liver resection in Korea. Questionnaires were sent to 24 centers of KLLSG. The questionnaire consisted of operative procedure, histological diagnosis of liver lesions, indications for resection, causes of conversion to open surgery, and postoperative outcomes. A laparoscopic liver resection was performed in 416 patients from 2001 to 2008. Of 416 patients, 59.6% had malignant tumors, and 40.4% had benign diseases. A total laparoscopic approach was performed in 88.7%. Anatomical laparoscopic liver resection was more commonly performed than non-anatomical resection (59.9% vs 40.1%). The anatomical laparoscopic liver resection procedures consisted of a left lateral sectionectomy (29.3%), left hemihepatectomy (19.2%), right hemihepatectomy (6%), right posterior sectionectomy (4.3%), central bisectionectomy (0.5%), and caudate lobectomy (0.5%). Laparoscopy-related serious complications occurred in 12 (2.8%) patients. The present study findings provide data in terms of indication, type and method of liver resection, and current status of laparoscopic liver resection in Korea.
*Hepatectomy/statistics & numerical data
;
Humans
;
*Laparoscopy/statistics & numerical data
;
Liver/*surgery
;
Liver Diseases/pathology/surgery
;
Liver Neoplasms/pathology/surgery
;
Postoperative Complications/epidemiology
;
Questionnaires
;
Republic of Korea

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