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.

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.

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.

Background: To assess the effectiveness of rescue cerclage concerning pregnancy and neonatal outcomes in women with acute cervical insufficiency (CI) complicated with intraamniotic inflammation (IAI) compared with those managed expectantly. Methods: This retrospective cohort study included 87 consecutive singleton pregnant women (17–25 weeks) with acute CI who underwent amniocentesis to assess IAI. Amniotic fluid (AF) samples were assayed for interleukin-6 to define IAI (≥ 2.6 ng/mL). Primary and secondary outcomes were assessed in a subset of CI patients with IAI. The primary outcome measures were spontaneous preterm birth (SPTB) at < 28 and < 34 weeks, and the secondary outcomes were interval from sampling to delivery, neonatal survival, neonatal birth weight, and histologic and clinical chorioamnionitis. Macrolide antibiotics were prescribed depending on the type of microorganism isolated from the AF, clinically suspected IAI, and the discretion of the attending clinician. Results: IAI was identified in 65.5% (57/87) of patients with CI, of whom 73.6% (42/57) were treated with macrolide antibiotics. Among the CI patients with IAI (n = 57), 40 underwent rescue cerclage and 17 were expectantly managed. The rates of SPTBs at < 28 and < 34 weeks were significantly lower and the latency period was significantly longer in the cerclage group than in the group that was managed expectantly. The median birth weight and neonatal survival rate were significantly higher in the cerclage group than in the group that was managed expectantly. However, the rates of histologic and clinical chorioamnionitis did not differ between the groups. Multivariable analyses revealed that rescue cerclage placement and administration of macrolide antibiotics were significantly associated with a decrease in SPTBs at < 28 and < 34 weeks, prolonged gestational latency, and increased likelihood of neonatal survival, after adjusting for possible confounding parameters; however, macrolide antibiotic administration did not reach statistical significance with respect to SPTB at < 34 weeks and neonatal survival (P = 0.076 and 0.063, respectively). Conclusion Rescue cerclage along with macrolide antibiotic treatment may positively impact pregnancy and neonatal outcomes in women with CI complicated by IAI, compared with expectant management. These findings suggest the benefit of cerclage placement even in patients with CI complicated by IAI.