From: Unfair older patients restriction in cancer drug trials in mainland China and corresponding solution
Variables | 65 + patients | 75 + patients | ||||
---|---|---|---|---|---|---|
OR (95%CI) | p value | OR (95%CI) | p value | |||
Study phase | ||||||
Phase I | 1 | 1 | ||||
Phase II | 0.08 | (0.05–0.14) | < 0.001 | 0.42 | (0.34–0.52) | < 0.001 |
Phase III | 0.07 | (0.04–0.13) | < 0.001 | 0.66 | (0.52–0.84) | 0.009 |
Phase IV | 0.06 | (0.01,0.46) | 0.0065 | 0.34 | (0.16–0.75) | 0.0076 |
Study scope | ||||||
International multicenter trial | 1 | 1 | ||||
Domestic trials | 12.52 | (3.89–40.31) | < 0.001 | 8.69 | (5.89–12.82) | < 0.001 |
Sponsor type | ||||||
Global industry | 1 | |||||
Domestic industry | 6.15 | (4.51–8.38) | < 0.001 | |||
Drug effect | ||||||
Therapeutic medication | 1 | 1 | ||||
Diagnosis medication | < 0.01 | 0 | 1.76 | (0.08–28.03) | 0.72 | |
Adjuvant medication | 5.07 | (3.47–7.40) | < 0.001 | 2.19 | (1.53–3.14) | < 0.001 |
Drug type | ||||||
Innovative drug | 1 | 1 | ||||
Biosimilar | 15.50 | (9.35–25.67) | < 0.001 | 2.78 | (1.68–4.61) | < 0.001 |
Generics | 1.98 | (1.1–3.56) | 0.023 | 1.83 | (1.07–3.12) | 0.03 |
Drug molecule | ||||||
Biological Products | 1 | 1 | ||||
Chemistry medicine | 4.64 | (3.37–6.38) | < 0.001 | 0.84 | (0.70–1.00) | 0.05 |
TCM/NM | 10.80 | (3.54–32.95) | < 0.001 | 6.91 | (2.16–22.13) | 0.001 |