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Table 3 Multivariable analysis of factors predicting age restriction of cancer trials among older patients

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