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FDA in the Twenty-First CenturyThe Challenges of Regulating Drugs and New Technologies$
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Holly Fernandez Lynch and I. Glenn Cohen

Print publication date: 2015

Print ISBN-13: 9780231171182

Published to Columbia Scholarship Online: May 2016

DOI: 10.7312/columbia/9780231171182.001.0001

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PRINTED FROM COLUMBIA SCHOLARSHIP ONLINE (www.columbia.universitypressscholarship.com). (c) Copyright University of Minnesota Press, 2021. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in CUPSO for personal use.date: 29 July 2021

Global Trends Toward Transparency in Participant-Level Clinical Trials Data

Global Trends Toward Transparency in Participant-Level Clinical Trials Data

Chapter:
(p.115) Chapter Six Global Trends Toward Transparency in Participant-Level Clinical Trials Data
Source:
FDA in the Twenty-First Century
Author(s):

Alla Digilova

Rebecca Li

Mark Barnes

Barbara Bierer

Publisher:
Columbia University Press
DOI:10.7312/columbia/9780231171182.003.0009

In this chapter, the authors review recent regulatory and private efforts focused on broadening access to participant-level data collected as part of clinical trials. The authors consider the risks and benefits of increased data transparency and outline the features of a well-designed data-sharing model that would protect the essential interests of research participants and clinical trial sponsors.

Keywords:   clinical trials transparency, participant-level data, data-sharing, secondary research, open access to clinical trials data, data release

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