Table 2

Correct answers to questions about the comprehension of the informed consent

Questions and correct answersNumber of patients answeringNumber of patients with correct answer (%)
1. Are you participating in a clinical trial?
 Yes7748 (62)
2. Which study have you been enrolled in?
 Reporting the right name of the study or some key details about the study7713 (17)
3. What is the name of the treatment?
 Indicating the correct name of the study drug7718 (23)
4. Are there some benefits from participating in this study?
 No; benefits in term of increasing scientific knowledge; or unknown benefits7710 (13)
5. If there are benefits, which are they?
 Benefits in term of increasing scientific knowledge328 (25)
6. What are the risks?
 Side effects from study drug; the study drug may not stop the tumour; do not know7728 (36)
7. What are the possible adverse events?
 Listing some of the possible side effects7731 (40)
8. Do you know the procedures of the study?
 Yes; at least in part7734 (44)
9. How many visits are required for the purpose of this clinical trial?
 Reporting the number of visits required for the purpose of the clinical trial7712 (16)
10. Did you have additional procedures compared to the standard treatment for your cancer?
 Yes7716 (21)
11. If yes, list the additional procedures
 Listing at least some of the additional procedures1614 (87)
12. Were blood samples requested by the study?
 Yes7734 (44)
13. Should you have not participated in this study, what treatment would you have received?
 Listing the name of the standard treatment7720 (26)
14. Do all the patients enrolled in this clinical trial receive the same medical treatment?
 No778 (10)
Number of correct answers (median (IQR))3 (0–7)