Andrew J Solomon1, Eran P Klein2, John R Corboy3, James L Bernat4. 1. University of Vermont College of Medicine, USA andrew.solomon@uvm.edu. 2. Oregon Health and Sciences University and Portland VA Medical Center, USA; Department of Philosophy, University of Washington, USA. 3. University of Colorado School of Medicine, USA; Denver Veterans Affairs Medical Center, USA. 4. Neurology Department, Dartmouth-Hitchcock Medical Center, USA.
Abstract
BACKGROUND: Pharmaceutical industry financial support of physicians, physician practices, and academic departments involved in multicenter industry-sponsored clinical trials of novel therapeutic agents is a relatively new and infrequently acknowledged source of potential physician conflict of interest. Detailed disclosure of these relationships to study participants is not uniformly a part of informed consent and documentation practices. OBJECTIVE: To understand attitudes of patients with multiple sclerosis concerning disclosure of potential physician-industry conflicts of interest created by clinical trials and how such disclosures may influence study participation METHODS: An anonymous online instrument was developed. RESULTS: 597 people with multiple sclerosis participated in the study. The study found that detailed disclosure of conflicts of interest is important to potential participants in industry-sponsored clinical trials for multiple sclerosis therapies and that the presence of these conflicts of interest may influence patients' decisions to participate in these studies. CONCLUSIONS: Findings from this study support a call for uniform guidelines regarding disclosure of physician-industry relationships to prospective research participants for industry-sponsored clinical trials.
BACKGROUND: Pharmaceutical industry financial support of physicians, physician practices, and academic departments involved in multicenter industry-sponsored clinical trials of novel therapeutic agents is a relatively new and infrequently acknowledged source of potential physician conflict of interest. Detailed disclosure of these relationships to study participants is not uniformly a part of informed consent and documentation practices. OBJECTIVE: To understand attitudes of patients with multiple sclerosis concerning disclosure of potential physician-industry conflicts of interest created by clinical trials and how such disclosures may influence study participation METHODS: An anonymous online instrument was developed. RESULTS: 597 people with multiple sclerosis participated in the study. The study found that detailed disclosure of conflicts of interest is important to potential participants in industry-sponsored clinical trials for multiple sclerosis therapies and that the presence of these conflicts of interest may influence patients' decisions to participate in these studies. CONCLUSIONS: Findings from this study support a call for uniform guidelines regarding disclosure of physician-industry relationships to prospective research participants for industry-sponsored clinical trials.
Authors: Andre M Samuel; Matthew L Webb; Adam M Lukasiewicz; Daniel D Bohl; Bryce A Basques; Glenn S Russo; Vinay K Rathi; Jonathan N Grauer Journal: Clin Orthop Relat Res Date: 2015-06-19 Impact factor: 4.176