Reflections and insights into the evolution of restrictive eligibility criteria for cancer clinical trials in China and beyond

Huiyao Huang , Huilei Miao , Jinling Tang , Ning Li

Cancer Communications ›› 2025, Vol. 45 ›› Issue (6) : 673 -676.

PDF
Cancer Communications ›› 2025, Vol. 45 ›› Issue (6) : 673 -676. DOI: 10.1002/cac2.70007
NEWS AND VIEWS

Reflections and insights into the evolution of restrictive eligibility criteria for cancer clinical trials in China and beyond

Author information +
History +
PDF

Cite this article

Download citation ▾
Huiyao Huang, Huilei Miao, Jinling Tang, Ning Li. Reflections and insights into the evolution of restrictive eligibility criteria for cancer clinical trials in China and beyond. Cancer Communications, 2025, 45(6): 673-676 DOI:10.1002/cac2.70007

登录浏览全文

4963

注册一个新账户 忘记密码

References

[1]

Rothwell PM. External validity of randomized controlled trials: “to whom do the results of this trial apply?”. Lancet. 2005; 365(9453): 82–93.

[2]

Garcia S, Bisen A, Yan J, Xie XJ, Ramalingam S, Schiller JH, et al. Thoracic Oncology Clinical Trial Eligibility Criteria and Requirements Continue to Increase in Number and Complexity. J Thorac Oncol. 2017; 12(10): 1489–95.

[3]

Peterson JS, Plana D, Bitterman DS, Johnson SB, Aerts H, Kann BH. Growth in eligibility criteria content and failure to accrue among National Cancer Institute (NCI)-affiliated clinical trials. Cancer Med. 2023; 12(4): 4715–24.

[4]

Giantonio BJ. Eligibility in Cancer Clinical Research: The Intersection of Discovery, Generalizability, Beneficence, and Justice. Clin Cancer Res. 2021; 27(9): 2369–71.

[5]

Huang H, Tang Y, Wu D, Meng X, Wang S, Wang J, et al. Unfair older patients restriction in cancer drug trials in mainland China and corresponding solution. BMC Geriatr. 2023; 23(1): 199.

[6]

Xiao H, Vaidya R, Hershman DL, Unger JM. Impact of Broadening Trial Eligibility Criteria on the Inclusion of Patients With Brain Metastases in Cancer Clinical Trials: Time Series Analyses for 2012-2022. J Clin Oncol. 2024; 42(16): 1953–60.

[7]

Jin S, Pazdur R, Sridhara R. Re-Evaluating Eligibility Criteria for Oncology Clinical Trials: Analysis of Investigational New Drug Applications in 2015. J Clin Oncol. 2017; 35(33): 3745–52.

[8]

U.S. Food and Drug Administration. Cancer Clinical Trial Eligibility Criteria: Laboratory Values. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cancer-clinical-trial-eligibility-criteria-laboratory-values. Accessed on October 1th, 2024.

[9]

Nastoupil LJ, Jain MD, Feng L, Spiegel JY, Ghobadi A, Lin Y, et al. Standard-of-Care Axicabtagene Ciloleucel for Relapsed or Refractory Large B-Cell Lymphoma: Results From the US Lymphoma CAR T Consortium. J Clin Oncol. 2020; 38(27): 3119–28.

[10]

U.S. Food and Drug Administration. ICH HARMONISED GUIDELINE GOOD CLINICAL PRACTICE (GCP) E6(R3). https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf. Accessed on January 22th, 2025.

[11]

U.S. Food and Drug Administration. Evaluating inclusion and exclusion criteria in clinical trials. https://www.fda.gov/media/134754/download. Accessed on April 4th, 2024.

[12]

Liu R, Rizzo S, Whipple S, Pal N, Pineda AL, Lu M, et al. Evaluating eligibility criteria of oncology trials using real-world data and AI. Nature. 2021; 592(7855): 629–33.

[13]

Huang H, Jia S, Wang X, Miao H, Fang H, He H, et al. Quantitative evaluation of the impact of relaxing eligibility criteria on the risk-benefit profile of drugs for lung cancer based on real-world data. Thorac Cancer. 2024; 15(14): 1187–94.

RIGHTS & PERMISSIONS

2025 The Author(s). Cancer Communications published by John Wiley & Sons Australia, Ltd on behalf of Sun Yat-sen University Cancer Center.

AI Summary AI Mindmap
PDF

20

Accesses

0

Citation

Detail

Sections
Recommended

AI思维导图

/