文章基本信息

标题：Promoting Transparency in Pharmaceutical Industry–Sponsored Research
本地全文：下载
作者：Joseph S. Ross ; Cary P. Gross ; Harlan M. Krumholz 等
期刊名称：American journal of public health
印刷版ISSN：0090-0036
出版年度：2012
卷号：102
期号：1
页码：72-80
DOI：10.2105/AJPH.2011.300187
语种：English
出版社：American Public Health Association
摘要：Strong, evidence-based practice requires that objective, unbiased research be available to inform individual clinical decisions, systematic reviews, meta-analyses, and expert guideline recommendations. Industry has used seeding trials, publication planning, messaging, ghostwriting, and selective publication and reporting of trial outcomes to distort the medical literature and undermine clinical trial research by obscuring information relevant to patients and physicians. Policies that promote transparency in the clinical trial research process, through improved and expanded disclosure of investigator contributions and funding, comprehensive publicly available trial registration, and independent analysis of clinical trial data analysis may address these subversive practices by improving accountability among industry and investigators. Minimizing marketing's impact on clinical trial research and strengthening the science will protect medical literature's integrity and the public's health. Evidence-based medical practice requires that objective, unbiased research be readily available to clinicians, investigators, and regulators to be used to inform individual clinical decisions and for systematic reviews, meta-analyses, and expert guideline recommendations. However, there is increasing awareness and concern about the role of the pharmaceutical and medical device industries in clinical research and their impact on the medical literature, which is partially driven by research demonstrating a positive relationship between sponsorship and findings. For instance, a meta-analysis of 1140 original research studies found that industry-sponsored trials had 3.5 times greater odds of reporting pro-industry conclusions. 1 Subsequent meta-analyses confirmed this finding among both medical and surgical 2 and recent major cardiovascular randomized controlled trials. 3 Collaborations between academic physicians and industry are essential for advancing scientific knowledge and improving the care of patients. However, there have been a number of recent exposés describing problems with industry-sponsored trials, including issues related to withholding trial data, the involvement of marketing, inappropriate authorship, and lack of accountability. These and related concerns remain a dominant issue in public and professional discourse. 4–8 We have reviewed several practices that industry has used to distort the medical literature and undermine clinical trial research, explicitly by obscuring information that is relevant to patients and physicians. We subsequently have described the value of promoting transparency to address these practices, specifically describing the need for improved disclosure and registration practices and independent analysis of clinical trial data.