Industry Sponsorship Bias in Collagenase Clinical Trials for Dupuytren Disease

Author:

Gray Kelsey M.1,Khatiwada Priyenka2,Capito Anthony E.1

Affiliation:

1. Virginia Tech Carilion Clinic

2. Virginia Tech Carilion School of Medicine

Abstract

Background Collagenase clostridium histolyticum (collagenase) was introduced in 2010 creating a nonoperative treatment option for Dupuytren disease with promising results in sponsored clinical trials. A meta-analysis was performed to investigate industry sponsorship bias. Methods A systematic review of collagenase treatment of Dupuytren contracture was conducted. Articles containing mesh terms including “microbial collagenase” and “Dupuytren's contracture” were searched and limited to only clinical trials with similar protocols for inclusion. Meta-analysis of treatment endpoints of correction of contracture to 0–5 degrees after first and last injection was conducted comparing sponsored versus nonsponsored studies. Results Sixteen of the 29 identified articles met criteria for inclusion. Nonsponsored studies reported a significantly higher rate of meeting the primary treatment endpoint compared to sponsored studies after single injection for all joints (69.6% vs 56% P < 0.01), metacarpophalangeal joint (96% vs 64% P < 0.01), and proximal interphalangeal joint (67% vs 36% P = 0.011). The correction in contracture rates was similar between groups with studies evaluating more than one injection. Conclusions Nonsponsored studies published higher success rates in meeting the primary endpoint of full correction after single injection than sponsored studies; however, similar results with multiple injections. This study demonstrated that sponsored studies of collagenase produced highly powered studies that may be reliably depended on for evidence-based clinical application.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Reference28 articles.

1. Prevalence, incidence, and treatments of Dupuytren's disease in the United States: results from a population-based study;Hand,2011

2. Dupuytren contractures: an update of recent literature;J Hand Surg Am,2021

3. The early history of Dupuytren's disease;Hand Clin,1999

4. Surgical complications associated with fasciectomy for dupuytren's disease: a 20-year review of the English literature;Eplasty,2010

5. Sponsorship bias in clinical trials: growing menace or dawning realisation?;J R Soc Med,2020

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3