BACKGROUND: An earlier study showed that from a societal perspective it was less expensive to encourage patients to self-regulate their medication for GERD (gastro-esophageal reflux disease) by treating patients on-demand. OBJECTIVE: The objective was to investigate whether physician involvement in a clinical trial financed by the pharmaceutical industry subsequently results in higher health care costs. STUDY DESIGN: An open, observational, multicenter study compared direct medical costs and total costs for three groups of patients with different exposure to the clinical trial; (1) Dual exposed, where both the patients and the GP participated in the former clinical trial, (2) GP exposed, where only the GP participated in the former clinical trial and (3) nonexposed, where neither the patients nor the GP participated in the former clinical trial. RESULTS: We did not find any statistically significant differences in neither direct medical nor total costs. However, we did observe a numerical difference in direct medical costs of 24% higher in the dual exposed group compared to the nonexposed group mainly due to a higher consumption of prescribed medication. The higher direct medical cost in the dual exposed group was however counterbalanced by lower observed direct nonmedical and indirect costs. CONCLUSION: Although we did not find any statistical significant differences in health care costs, we did observe a higher consumption of prescribed medication and lower costs of work hours lost if both patient and GPs participated in a former clinical trial. The results may be limited due to a lower number of patients included than expected.
BACKGROUND: An earlier study showed that from a societal perspective it was less expensive to encourage patients to self-regulate their medication for GERD (gastro-esophageal reflux disease) by treating patients on-demand. OBJECTIVE: The objective was to investigate whether physician involvement in a clinical trial financed by the pharmaceutical industry subsequently results in higher health care costs. STUDY DESIGN: An open, observational, multicenter study compared direct medical costs and total costs for three groups of patients with different exposure to the clinical trial; (1) Dual exposed, where both the patients and the GP participated in the former clinical trial, (2) GP exposed, where only the GP participated in the former clinical trial and (3) nonexposed, where neither the patients nor the GP participated in the former clinical trial. RESULTS: We did not find any statistically significant differences in neither direct medical nor total costs. However, we did observe a numerical difference in direct medical costs of 24% higher in the dual exposed group compared to the nonexposed group mainly due to a higher consumption of prescribed medication. The higher direct medical cost in the dual exposed group was however counterbalanced by lower observed direct nonmedical and indirect costs. CONCLUSION: Although we did not find any statistical significant differences in health care costs, we did observe a higher consumption of prescribed medication and lower costs of work hours lost if both patient and GPs participated in a former clinical trial. The results may be limited due to a lower number of patients included than expected.