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

Background: The rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess. There is scarce evidence about the perception of these participants about the ethical compliance, security, and protection. We sought to evaluate and contrast the awareness and perception of participants and non-participants of industry-sponsored research trials (ISRT) on ethical, safety, and protection topics. Methods: A Cases-control survey conducted at twelve research sites in México. Previous and current participants of ISRT (cases) as well as non-participants (controls) with one of four chronic diseases, were asked to complete the survey which focused on ethical compliance and protection issues of ISRT, and the perception of participating in a trial. Results: A total of 604 cases and 604 controls were surveyed. Cases significantly answered that ethics committees are aware of what is happening in studies (50.5% vs. 33.8%, P=≤ 0.001), and that medical care of industry-sponsored research trials is better than their usual medical care (77.2% vs. 38.2%, P=<0.001).Thesameproportionofcasesand controls thought patients must receive economical reimbursement for participating in a research study (49.5% vs. 53.1%, P=0.205). The informed consent of the pharmaceutical clinical trial was fully read by 90.4% of the cases. Most cases were satisfied or very satisfied with their overall study participation (35.6 and 62.3%, respectively). Conclusion: Previous and current participants of industry-sponsored research trials have a more positive attitude towards ethics committees, the quality of medical care of the research trials, and the main purpose of economical reimbursements, when compared to non-participants. Keywords: Good clinical practices, Perception, Clinical trials, Pharmaceutical industry, Ethics committee

Participants' perception of pharmaceutical clinical research: a cross-sectional controlled study

Background: There is scarce scientific information assessing participants’ perception of pharmaceutical research in developed and developing countries concerning the risks, safety, and purpose of clinical trials. Methods: To assess the perception that 604 trial participants (cases) and 604 nonparticipants (controls) of pharmaceutical clinical trials have about pharmaceutical clinical research, we surveyed participants with one of four chronic diseases from 12 research sites throughout Mexico. Results: Participation in clinical trials positively influences the perception of pharmaceutical clinical research. More cases (65.4%) than controls (50.7%) perceived that the main purpose of pharmaceutical research is to cure more diseases and to do so more effectively. In addition, more cases considered that there are significant benefits when participating in a research study, such as excellent medical care and extra free services, with this being the most important motivation to participate for both groups (cases 52%, controls 54.5%). We also found a sense of trust in their physicians to deal with adverse events, and the perception that clinical research is a benefit to their health, rather than a risk. More controls believed that clinical trial participants’ health is put at risk (57% vs 33.3%). More cases (99.2%) than controls (77.5%) would recommend participating in a clinical trial, and 90% of cases would enroll in a clinical trial again. Conclusion: Participation in clinical trials positively influences the perception that participants have about pharmaceutical clinical research when compared to nonparticipants. This information needs to be conveyed to clinicians, public health authorities, and general population to overcome misconceptions

Use of antibiotics in upper respiratory infections on patients under 16 years old in private ambulatory medicine

OBJECTIVE: To assess antibiotic use for upper respiratory infections (URI) treatment on patients under 16 years-old who are beneficiaries of a pre-paid health care scheme. MATERIAL AND METHODS: A database containing the record of all the medical prescriptions for URI treatment, from May 1997 to April 1998 was analyzed. Patients were under 16 years old and had been diagnosed with common colds, pharyngitis, bronchitis, sinusitis, otitis, and other unspecified upper respiratory tract infections. Three hundred and fifty-one physicians of seven different specialties who attended 25 300 beneficiaries wrote such prescriptions. RESULTS: A total of 30 889 assorted medications were prescribed to 5 533 patients with the above diagnoses. Antibiotics were prescribed for 77.5% of all diagnoses, ranging from 58% for pharyngitis to 91% for laryngitis. The most frequently used antibiotics were: penicillin, cephalosporins, and macrolides. CONCLUSIONS: This study presents the information of antibiotics prescription practices for URI in a pre-paid health plan in Mexico. These findings may be used to support specific campaigns for rational use of antibiotics among children attended at private ambulatory health care practices