Pro-Con Debate: Interdisciplinary Perspectives on Industry- Sponsored Research

被引:2
|
作者
Sessler, Daniel I. [1 ,5 ]
Alman, Benjamin A. [2 ]
Treggiari, Miriam M. [3 ]
Mont, Michael A. [4 ]
机构
[1] Cleveland Clin, Anesthesiol Inst, Dept Outcomes Res, Cleveland, OH USA
[2] Duke Univ, Dept Orthoped Surg, Med Ctr, Durham, NC USA
[3] Duke Univ, Dept Anesthesiol, Med Ctr, Durham, NC USA
[4] Sinai Hosp Baltimore, Rubin Inst Adv Orthoped, Baltimore, MD USA
[5] Cleveland Clin, Anesthesiol Inst, Dept Outcomes Res, 9500 Euclid Ave, P77, Cleveland, OH 44195 USA
来源
JOURNAL OF ARTHROPLASTY | 2023年 / 38卷 / 06期
基金
加拿大健康研究院; 美国国家卫生研究院;
关键词
FUJII ET-AL; POSTOPERATIVE NAUSEA; TRIALS;
D O I
10.1016/j.arth.2023.02.018
中图分类号
R826.8 [整形外科学]; R782.2 [口腔颌面部整形外科学]; R726.2 [小儿整形外科学]; R62 [整形外科学(修复外科学)];
学科分类号
摘要
Pro: Nearly all new devices and drugs come from industry that provides two-thirds of the funding for medical research, and a much higher fraction of clinical research. Realistically, without corporate-funded studies, perioperative research would stagnate with little innovation and few new products. Opinions are ubiquitous and normal but do not constitute epidemiologic bias. Competent clinical research includes many protections against selection and measurement bias, and the publication process provides at least moderate protection against misinterpretation of results. Trial registries largely prevent selective data presentation. Sponsored trials are particularly protected against inappropriate corporate influence because they are usually codesigned with the US Food and Drug Administration, and analyses are based on formal predefined statistical plans, as well as being conducted with rigorous external monitoring. Novel products, which are essential for advances in clinical care, largely come from industry, and industry appropriately funds much of the required research. We should celebrate industry's contribution to improvements in clinical care. Con: While industry funding contributes to research and discovery, examples of industry-funded research demonstrate bias. In the setting of financial pressures and potential conflict of interest, bias can influence the type of study design, hypotheses being tested, rigor and transparency in data analysis, interpretation, as well as reporting of the results. Unlike public granting agencies, industry does not necessarily provide funding based on unbiased peer review following an open call for proposals. The focus on success can influence the choice of a comparator, which might not be ideal among the possible alternatives, the language used in the publication, and even the ability to publish. Unpublished negative trials can result in selected information being withheld from the scientific community and the public. Appropriate safeguards are needed to ensure that research addresses the most important and relevant questions, that results are available even when they do not support the use of a product produced by the funding company, that populations studied reflect the relevant patients, that the most rigorous ap-proaches are applied, that studies have the appropriate power to address the question posed, and that conclusions are presented in an unbiased manner.Copyright & COPY; 2023 Elsevier Inc and International Anesthesia Research Society. Published by Elsevier Inc and Wolters Kluwer Health, Inc. All rights reserved.
引用
收藏
页码:986 / 991
页数:6
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