Sharing clinical trial data : maximizing benefits, minimizing risk

Sharing clinical trial data maximizing benefits, minimizing risk

Detalles Bibliográficos
Autor principal: Institute of Medicine (U.S.) (author)
Autores Corporativos: Institute of Medicine (U.S.), author (author), Institute of Medicine (U.S.). Committee on Strategies for Responsible Sharing of Clinical Trial Data, issuing body (issuing body), Institute of Medicine (U.S.). Board on Health Sciences Policy, issuing body
Formato: Libro electrónico
Idioma:Inglés
Publicado: Washington, District of Columbia : The National Academies Press 2015.
Edición:1st ed
Materias:
Clinical trials > Data processing.
Ver en Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009622437806719
Tabla de Contenidos:
  • 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.

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