Cancer Res Treat.  2025 Jan;57(1):39-46. 10.4143/crt.2024.421.

The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group

• Kim BJ
• Maeng CH
• Keam B
• Im YH
• Ro J
• Jung KH
• Im SA
• Kim TW
• Lee JL
• Heo DS
• Kim SW
• Park K
• Ahn MJ
• Cho BC
• Kim HK
• Kang YK
• Cho JY
• Yun HJ
• Nam BH
• Zang DY

• KMID: 2564579
• DOI: http://doi.org/10.4143/crt.2024.421

Abstract

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.

Keyword

Investigator-initiated trials; Survival analysis; Cost analysis; Korean Cancer Study Group

Figure

• 

  Fig. 1. Number of IITs conducted through KCSG. (A) The number of initiated & published IITs through KCSG by year. (B) The number of published IITs by cancer type. Gu & Gy, genitourinary and gynecologic; HBP, hepatopancreatobiliary; H & N, head and neck; IITs, investigator-initiated trials; KCSG, Korean Cancer Study Group. a)Data on the number of initiated IITs by year are available since 2009.

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  Fig. 2. Flow diagram of included studies. KCSG, Korean Cancer Study Group; OS, overall survival; PFS, progression-free survival.

Reference

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