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Table 3 Comparison of survey questions only for cases by disease groupa

From: Participants’ awareness of ethical compliance, safety and protection during participation in pharmaceutical industry clinical trials: a controlled survey

Questions and answers   Disease Group  
Total T2DM COPD RA HT P value
(n = 604) (n = 151) (n = 151) (n = 151) (n = 151)  
Enrollment
 10. How were you invited to participate in your current or most recent research study?
  By a clinical researcher participating in the study. 190 (31.5) 43 (28.5) 51 (33.8) 76 (50.3) 20 (13.2) < 0.001
  In the research physician’s private consult. 120 (19.9) 25 (16.6) 36 (23.8) 26 (17.2) 33 (21.9)  
  A patient who participates in the research study invited me. 115 (19) 52 (34.4) 18 (11.9) 14 (9.3) 31 (20.5)  
  Other media. 65 (10.8) 14 (9.3) 14 (9.3) 9 (6) 28 (18.5)  
  In a disease detection campaign. 45 (7.5) 9 (6) 12 (7.9) 6 (4) 18 (11.9)  
  In a private medical consult. 39 (6.5) 5 (3.3) 9 (6) 6 (4) 19 (12.6)  
  Notice published at a hospital. 16 (2.6) 2 (1.3) 5 (3.3) 7 (4.6) 2 (1.3)  
  Newspaper advertisement. 13 (2.2) 1 (0.7) 5 (3.3) 7 (4.6) 0 (0)  
  Radio advertisement. 1 (0.2) 0 (0) 1 (0.7) 0 (0) 0 (0)  
  Notice published online. 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)  
  Television advertisement. 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)  
 11. Why did you decided to participate in your current research study?
  Because this is the best way to get medical care. 222 (36.8) 54 (35.8) 54 (35.8) 56 (37.1) 58 (38.4) < 0.001
  Because the physician’s care is more cautious. 159 (26.3) 52 (34.4) 41 (27.2) 31 (20.5) 35 (23.2)  
  Because I have not responded to available treatments. 112 (18.5) 21 (13.9) 15 (9.9) 28 (18.5) 48 (31.8)  
  Because my participation aids scientific medical progress. 65 (10.8) 11 (7.3) 25 (16.6) 22 (14.6) 7 (4.6)  
  Because I have no other way to get clinical care. 23 (3.8) 5 (3.3) 8 (5.3) 10 (6.6) 0 (0)  
  Because everything is free. 19 (3.1) 7 (4.6) 7 (4.6) 2 (1.3) 3 (2)  
  Other reason. 4 (0.7) 1 (0.7) 1 (0.7) 2 (1.3) 0 (0)  
Informed Consent
 12. Have you fully read the informed consent letter required to accept enrolling in the research study?
  Yes 546 (90.4) 138 (91.4) 137 (90.7) 129 (85.4) 142 (94) 0.079
  No 58 (9.6) 13 (8.6) 14 (9.3) 22 (14.6) 9 (6)  
 13. Why did you not read the informed consent letter?
  Because I fully trust that my physician would not put my health at risk. 33 (56.9) 4 (30.8) 9 (64.3) 14 (63.6) 6 (66.7) 0.115
  Because I did not have enough time to read it. 11 (19) 6 (46.2) 2 (14.3) 2 (9.1) 1 (11.1)  
  Because the document was very long. 8 (13.8) 2 (15.4) 3 (21.4) 1 (4.5) 2 (22.2)  
  Other reason. 3 (5.2) 1 (7.7) 0 (0) 2 (9.1) 0 (0)  
  Because I did not understand it, the text was not clear. 3 (5.2) 0 (0) 0 (0) 3 (13.6) 0 (0)  
 14. How much time did the research physician take to explain the research study’s process, risks and benefits, as well as your rights and obligations as a participant?
  More than 30 min. 262 (43.4) 56 (37.1) 33 (21.9) 64 (42.4) 109 (72.2) < 0.001
  20 to 30 min. 130 (21.5) 50 (33.1) 33 (21.9) 25 (16.6) 22 (14.6)  
  10 to 20 min. 107 (17.7) 27 (17.9) 33 (21.9) 35 (23.2) 12 (7.9)  
  No more than 10 min. 97 (16.1) 17 (11.3) 46 (30.5) 26 (17.2) 8 (5.3)  
  Less than 5 min. 8 (1.3) 1 (0.7) 6 (4) 1 (0.7) 0 (0)  
 15. How satisfied are you with the explanation received about the research study’s process, risks and benefits, as well as the protection you have in case of an adverse reaction related to the experimental drug?
Very satisfied. 326 (54) 81 (53.6) 78 (51.7) 70 (46.4) 97 (64.2) 0.043
Satisfied. 249 (41.2) 67 (44.4) 63 (41.7) 68 (45) 51 (33.8)  
Neither satisfied nor unsatisfied. 20 (3.3) 3 (2) 6 (4) 10 (6.6) 1 (0.7)  
Unsatisfied. 7 (1.2) 0 (0) 3 (2) 2 (1.3) 2 (1.3)  
Very unsatisfied. 2 (0.3) 0 (0) 1 (0.7) 1 (0.7) 0 (0)  
Cases’ experience participating in an industry-sponsored research trial
 16. How satisfied are you with your participation in this research study?
  Very satisfied. 376 (62.3) 90 (59.6) 89 (58.9) 83 (55) 114 (75.5) 0.009
  Satisfied. 215 (35.6) 61 (40.4) 58 (38.4) 61 (40.4) 35 (23.2)  
  Neither satisfied nor unsatisfied. 6 (1) 0 (0) 1 (0.7) 4 (2.6) 1 (0.7)  
  Unsatisfied. 3 (0.5) 0 (0) 1 (0.7) 2 (1.3) 0 (0)  
  Very unsatisfied. 4 (0.7) 0 (0) 2 (1.3) 1 (0.7) 1 (0.7)  
 17. How satisfied are you with the time your research physician dedicates you?
  Very satisfied. 413 (68.4) 106 (70.2) 94 (62.3) 90 (59.6) 123 (81.5) 0.003
  Satisfied. 179 (29.6) 44 (29.1) 53 (35.1) 57 (37.7) 25 (16.6)  
  Neither satisfied nor unsatisfied. 5 (0.8) 1 (0.7) 1 (0.7) 2 (1.3) 1 (0.7)  
  Unsatisfied. 3 (0.5) 0 (0) 0 (0) 1 (0.7) 2 (1.3)  
  Very unsatisfied. 4 (0.7) 0 (0) 3 (2) 1 (0.7) 0 (0)  
 18. How satisfied are you with your research physician’s sense of humanity?
  Very satisfied. 466 (77.2) 124 (82.1) 113 (74.8) 103 (68.2) 126 (83.4) 0.019
  Satisfied. 133 (22) 27 (17.9) 36 (23.8) 47 (31.1) 23 (15.2)  
  Neither satisfied nor unsatisfied. 1 (0.2) 0 (0) 1 (0.7) 0 (0) 0 (0)  
  Unsatisfied. 2 (0.3) 0 (0) 0 (0) 0 (0) 2 (1.3)  
  Very unsatisfied. 2 (0.3) 0 (0) 1 (0.7) 1 (0.7) 0 (0)  
 19. How easy is to talk to your research physician? (Availability)
  Very easy. 447 (74) 114 (75.5) 108 (71.5) 97 (64.2) 128 (84.8) 0.021
  Easy. 143 (23.7) 36 (23.8) 37 (24.5) 49 (32.5) 21 (13.9)  
  Neither easy nor difficult. 10 (1.7) 1 (0.7) 5 (3.3) 3 (2) 1 (0.7)  
  Difficult. 2 (0.3) 0 (0) 0 (0) 1 (0.7) 1 (0.7)  
  Very difficult. 2 (0.3) 0 (0) 1 (0.7) 1 (0.7) 0 (0)  
 20. How satisfied are you when talking to the research physician?
  Very satisfied. 457 (75.7) 117 (77.5) 105 (69.5) 106 (70.2) 129 (85.4) 0.019
  Satisfied. 136 (22.5) 34 (22.5) 40 (26.5) 41 (27.2) 21 (13.9)  
  Neither satisfied nor unsatisfied. 5 (0.8) 0 (0) 2 (1.3) 3 (2) 0 (0)  
  Very unsatisfied. 4 (0.7) 0 (0) 3 (2) 1 (0.7) 0 (0)  
  Unsatisfied. 2 (0.3) 0 (0) 1 (0.7) 0 (0) 1 (0.7)  
 21. How satisfied are you with the results obtained regarding the research medical care of your disease?
  Very satisfied. 444 (73.5) 110 (72.8) 104 (68.9) 103 (68.2) 127 (84.1) 0.055
  Satisfied. 144 (23.8) 36 (23.8) 41 (27.2) 43 (28.5) 24 (15.9)  
  Neither satisfied nor unsatisfied. 12 (2) 5 (3.3) 4 (2.6) 3 (2) 0 (0)  
  Very unsatisfied. 3 (0.5) 0 (0) 2 (1.3) 1 (0.7) 0 (0)  
  Unsatisfied. 1 (0.2) 0 (0) 0 (0) 1 (0.7) 0 (0)  
  1. aData are given as n (%)
  2. T2DM Type 2 diabetes mellitus, COPD chronic obstructive pulmonary disease, RA rheumatoid arthritis, HT hypertension