Table 2 Univariate analysis of factors associated with age restriction proportion of cancer drug trials in China
From: Unfair older patients restriction in cancer drug trials in mainland China and corresponding solution
Variables | Age restriction of 65 years | Age restriction of 75 years | ||||
|---|---|---|---|---|---|---|
No | Yes | P value | No | Yes | P value | |
Study phase | < 0.001 | < 0.001 | ||||
Phase I | 75.3% | 24.7% | 33.8% | 66.2% | ||
Phase II | 97.4% | 2.6% | 58.9% | 41.1% | ||
Phase III | 97.8% | 2.2% | 68.7% | 31.3% | ||
Phase IV | 97.6% | 2.4% | 68.3% | 31.7% | ||
Study scope | < 0.001 | < 0.001 | ||||
Domestic trials | 77.4% | 22.6% | 37.2% | 62.8% | ||
International multicenter trial | 99.5% | 0.5% | 94.2% | 5.8% | ||
Sponsor type | < 0.001 | < 0.001 | ||||
Chinese company | 77.5% | 22.5% | 36.1% | 63.9% | ||
Global company | 96.2% | 3.8% | 91.2% | 8.8% | ||
Cancer type | 0.392 | 0.155 | ||||
Solid tumor | 81.4% | 18.6% | 46.2% | 53.8% | ||
Blood tumor | 79.8% | 20.2% | 51.9% | 48.1% | ||
Drug effect | < 0.001 | < 0.001 | ||||
Therapeutic medication | 93.9% | 16.8% | 48.5% | 51.5% | ||
Diagnosis medication | 100.0% | 0.0% | 50.0% | 50.0% | ||
Adjuvant medication | 50.9% | 49.1% | 24.1% | 75.9% | ||
Drug type | < 0.001 | < 0.001 | ||||
Innovative drug | 87.9% | 12.1% | 50.9% | 49.1% | ||
Biosimilar | 58.2% | 41.8% | 16.4% | 83.6% | ||
Generics | 49.6% | 50.4% | 33.7% | 66.3% | ||
Drug molecule | < 0.001 | < 0.001 | ||||
Chemistry medicine | 74.6% | 25.4% | 47.1% | 52.9% | ||
Biological Products | 91.7% | 8.3% | 47.9% | 52.1% | ||
TCM/NM | 84.8% | 15.2% | 12.1% | 87.9% | ||