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Table 2 Comparison of the answers between cases and controlsa

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

Questions and answers Cases Controls P value
n = 604 n = 604  
Ethics Committee
 1. What is your opinion about the Ethics Committees?
  I think most of the time they are aware of what is happening in these studies 305 (50.5) 204 (33.8) < 0.001
  I am aware they exist but I do not know their function 133 (22) 165 (27.3)  
  I do not know what an Ethics Committee is 111 (18.4) 127 (21)  
  I am aware that they exist but I am not sure if they fulfill their functions 45 (7.5) 56 (9.3)  
  I think most of the time they are not aware of what is happening in these studies 4 (0.7) 27 (4.5)  
  I am sure that most of the time they are not responsible of fulfilling their function 5 (0.8) 24 (4)  
  Other opinion 1 (0.2) 1 (0.2)  
 2. Which is the main function of an Ethics Committee?
  To ensure that research physicians and their collaborators are adequately qualified 180 (29.8) 192 (31.8) 0.293
  I do not know precisely what responsibilities they must fulfill 175 (29) 189 (31.3)  
  To review whether the research study characteristics provide benefits to the participants 87 (14.4) 63 (10.4)  
  To approve or deny permission to execute a research study 67 (11.1) 62 (10.3)  
  To register the experimental drug’s adverse reactions as they occur 59 (9.8) 54 (8.9)  
  To interrupt the research study in case they consider that participants could be at risk 30 (5) 39 (6.5)  
  To make sure that the informed consent documents are easy to understand 4 (0.7) 5 (0.8)  
  Other function 2 (0.3) 0 (0)  
Research studies’ medical care
 3. What is your opinion about the research physicians that participate in pharmaceutical industry-sponsored studies?
  They must be qualified physicians evaluated by international pharmaceutical companies 545 (91.3) 374 (62.1) < 0.001
  I have no opinion on the matter because I do not know any research physician 25 (4.2) 109 (18.1)  
  They are like any other physician, the only difference is that they do this activity 20 (3.4) 67 (11.1)  
  I believe that most of them participate in this kind of studies only because of the money they are paid 5 (0.8) 41 (6.8)  
  I think that they must not be very good physicians 2 (0.3) 10 (1.7)  
  Other opinion 0 (0) 1 (0.2)  
 4. What is your opinion about the medical care that pharmaceutical industry research studies’ participants receive?
  It is much better than private medical care 464 (77.2) 230 (38.2) < 0.001
  It must be the same as private medical care 81 (13.5) 157 (26.1)  
  I do not know if it is better or worse than private medical care 14 (2.3) 128 (21.3)  
  I believe the most important fact is that the medical care is free of charge 33 (5.5) 48 (8)  
  It is inferior to private medical care 9 (1.5) 36 (6)  
  Other reason 0 (0) 3 (0.5)  
 5. Do you consider that participating in a clinical trial is an adequate way for patients to get medical care
  Yes 599 (99.2) 537 (88.9) < 0.001
  No 5 (0.8) 67 (11.1)  
 6. Why do you believe that participating in a clinical trial is an adequate way to get medical care?  
  Because participants receive closer follow-up than with any other medical center 308 (51.6) 175 (32.7) < 0.001
  Because participants receive new treatments that offer more advantages than any other medication available 71 (11.9) 107 (20)  
  Because international scientists are monitoring the medication’s effects 93 (15.6) 79 (14.8)  
  Because these are very strict studies where all medical adverse reactions are monitored 31 (5.2) 47 (8.8)  
  Because the physician is available and can be found easily 53 (8.9) 23 (4.3)  
  Although it is not ideal, it is the best way to get medical care if you lack economical resources to pay for it 12 (2) 51 (9.5)  
  Because they perform a lot of laboratory tests free of charge 19 (3.2) 34 (6.4)  
  Because physicians that do medical research are more qualified 10 (1.7) 19 (3.6)  
 7. Why do you believe that participating in a clinical trial is not an adequate way to get medical care?  
  Because of potential risks that are not present when using authorized treatments 0 (0) 30 (44.8) 0.005
  Because a lot of unnecessary laboratory tests are performed 1 (16.7) 16 (23.9)  
  Because treatments are interrupted once the research study is over 3 (50) 13 (19.4)  
  Because they require you to assist to a lot of unnecessary consults 1 (16.7) 7 (10.4)  
  Did not answered 1 (16.7) 0 (0)  
  Other reason 0 (0) 1 (1.5)  
Economical Reimbursement
 8. Do you believe that you must receive an economical reimbursement (money) for participating in a research study?
  Yes 299 (49.5) 321 (53.1) 0.205
  No 305 (50.5) 283 (46.9)  
 9. What is your opinion about receiving an economical reimbursement (money) for participating in a research study?
  There should not be monetary supportive stimuli unless they are strictly justified 274 (45.4) 223 (36.9) < 0.001
  That it is necessary in order to cover the costs of extra transportation that participating in a study implies 240 (39.7) 183 (30.3)  
  I think it is payment for risking my health 24 (4) 73 (12.1)  
  Other reason 17 (2.8) 36 (6)  
  I think it is a good payment for participating in a research study 13 (2.2) 39 (6.5)  
  I think it is used to convince some people to enroll in a research study 13 (2.2) 36 (6)  
  Monetary supportive stimuli are not proportionate to the potential risks that participating in a research study implies 23 (3.8) 14 (2.3)  
  1. aData are given as n (%)