Sharing clinical trial data : maximizing benefits, minimizing risk / Institute of Medicine.

Format:

Book

Author/Creator:

Institute of Medicine (U.S.), author.

Contributor:

Institute of Medicine (U.S.). Committee on Strategies for Responsible Sharing of Clinical Trial Data, issuing body.

Institute of Medicine (U.S.). Board on Health Sciences Policy, issuing body.

Language:

English

Subjects (All):

Clinical trials--Data processing.

Clinical trials.

Physical Description:

1 online resource (304 pages)

Edition:

1st ed.

Place of Publication:

Washington, District of Columbia : The National Academies Press, 2015.

Summary:

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Contents:

Intro

FrontMatter

Reviewers

Preface

Contents

Abstract

Summary

1 Introduction

2 Guiding Principles for Sharing Clinical Trial Data

3 The Roles and Responsibilities of Stakeholders in the Sharing of Clinical Trial Data

4 The Clinical Trial Life Cycle and When to Share Data

5 Access to Clinical Trial Data: Governance

6 The Future of Data Sharing in a Changing Landscape

Appendix A: Study Approach

Appendix B: Concepts and Methods for De-identifying Clinical Trial Data

Appendix C: Legal Discussion of Risks to Industry Sponsors

Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization

Appendix E: Biosketches of Committee Members.

Notes:

Includes bibliographical references at the end of each chapters.

Description based on online resource; title from PDF title page (ebrary, viewed May 21, 2015).

ISBN:

9780309316323

0309316324

9780309316309

0309316308

OCLC:

904734999