Author : Trudo Lemmens
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (137 download)
Book Synopsis Clinical Trial Transparency in the Americas by : Trudo Lemmens
Download or read book Clinical Trial Transparency in the Americas written by Trudo Lemmens and published by . This book was released on 2018 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Notwithstanding widespread support for clinical trials data transparency, its implementation faces significant challenges. Transparency of pharmaceutical data has been hampered by some industry resistance, by the qualification of such data as commercially confidential information, and by inconsistencies in overlapping regulatory spheres. This article discusses key developments related to registering pharmaceutical clinical trials and sharing data submitted to drug regulatory agencies in the Americas. Then, reports from three countries (Argentina, Brazil, Canada) are discussed to show what transparency measures they have implemented and what challenges remain. These short case studies shed light on various initiatives, positive outcomes, and persistent challenges -- even in countries with relatively advanced research, pharmaceutical product production, and regulatory sectors. They further highlight how different jurisdictions address the tension between public-health-oriented transparency initiatives and the tendency to treat data as commercial goods. Finally, the paper suggests that research ethics review could play a role in moving forward with data transparency, but it puts forward that research ethics governance ought to be developed more coherently in order to ensure the public accountability of the governance system.