Representative analysis of elderly subjects in clinical trials of prostate cancer drugs
10.3760/cma.j.issn.0254-9026.2022.10.013
- VernacularTitle:前列腺癌药物临床试验老年受试者样本代表性分析
- Author:
Huiqing YAO
1
;
Haijuan ZHAO
;
Miao MIAO
;
Qingqing WANG
;
Fei LIU
;
Lang ZHAO
;
Yao LIU
;
Ying ZHANG
;
Xin WANG
Author Information
1. 北京医院临床试验研究中心 国家老年医学中心 中国医学科学院老年医学研究院，北京 100730
- Keywords:
Prostatic neoplasms;
Drugs, investigational;
Age of onset
- From:
Chinese Journal of Geriatrics
2022;41(10):1197-1201
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze whether the sample of elderly subjects in clinical trials of prostate cancer drugs is representative.Methods:From the level of trial design, the age distribution of subjects in clinical trials of prostate cancer drugs for elderly patients from January 2019 to December 2021 was inquired on the platform of drug clinical trial registration and information disclosure.From the actual enrollment level, the prostate cancer drug clinical trials initiated and completed by a hospital from January 2010 to June 2022 were collected.The age information of subjects in all centers was collected for multicenter trials with a summary report, and the age data of subjects in the center was collected for trials without a summary report or single-center trials.The average age of prostate cancer onset and the incidence of prostate cancer in different age groups were compared with the Chinese Cancer Registry System, so as to compare whether the two were consistent.Results:Most of the trials(72.1%、44/61)did not set upper age limit at the protocol design level.Phase Ⅲ and phase Ⅳ trials did not set an upper age limit for enrolled subjects in the protocol.From the actual enrollment level, a total of 19 studies were included in this study, with 1 402 subjects, and the average age of subjects was 67.1±8.6 years old, which was significantly different from the average age of prostate cancer in China and Beijing(all P<0.001). The age group with the largest number of participants was 60-64 years old(34.2%、479/1 402). The population aged ≥75 years was the least(21.5%, 301/1 402), which was different from the high incidence age group of prostate cancer in China in 2017(421.77/100 000). Conclusions:Clinical trials of prostate cancer drugs are designed to cover all age groups of elderly patients, but the actual sample representation of the enrolled elderly subjects is insufficient.Under the premise of protecting the safety of subjects, the trial population who are matched for the average age of prostate cancer onset and the incidence of prostate cancer in age groups, should be gradually increased.
