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Age disparity between a cancer population and participants in clinical trials submitted as a new drug application of anticancer drugs in Japan
Version of Record online: 3 MAY 2007
Copyright © 2007 American Cancer Society
Volume 109, Issue 12, pages 2541–2546, 15 June 2007
How to Cite
Hori, A., Shibata, T., Kami, M., Kusumi, E., Narimatsu, H., Kishi, Y., Murashige, N. and Mori, K. (2007), Age disparity between a cancer population and participants in clinical trials submitted as a new drug application of anticancer drugs in Japan. Cancer, 109: 2541–2546. doi: 10.1002/cncr.22721
- Issue online: 4 JUN 2007
- Version of Record online: 3 MAY 2007
- Manuscript Accepted: 8 FEB 2007
- Manuscript Revised: 5 FEB 2007
- Manuscript Received: 5 JAN 2007
- elderly patients;
- anticancer drug;
- clinical trial;
- New Drug Application
Underrepresentation of older patients in cancer clinical trials has been reported previously.
To evaluate disparities in age between actual cancer patients and those enrolled in clinical trials, the authors examined all the review reports of the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan, and summaries of data submitted by applicants for the approval of new cancer drugs and that of a partial change in approved cancer drugs.
Information regarding 68 clinical trials was available on the Internet. The median age of trial participants ranged from 33 years to 73 years and was older than 65 years in 13 trials, whereas the estimated median age of patients with all cancers was 69 years, and 64% of these individuals were age ≥65 years. The median age of trial participants was found to be lower than that of the patient population in 60 trials. The median difference in age between the 2 groups was 7 years (range, −16 to +33). With regard to molecular-targeting agents (16 trials) and hormonal agents (10 trials), trial participants were younger than the patient population in 25 of the 26 trials, with a median difference of 6 years (range, −9.5 to +20). The difference was larger for molecular-targeting agents (median, 9.5 years; range, birth-20 years) compared with hormonal agents (median, 2 years; range, −9.5 to +15).
The results of the current study show that participants in cancer clinical trials are younger than the actual Japanese cancer patient population. Cancer 2007. © 2007 American Cancer Society.