The EMWA Budapest Working Group: A 2-year collaboration to make recommendations for aligning the ICH E3 guideline with current practice and developing clinical study protocol guidance. (December 2014)

• Record Type: Journal Article
• Authors: Hamilton, Sam; Seiler, Walther; Gertel, Art
• Is Part Of: Medical writing. Volume 23:Number 4(2014:Dec.)
• Page Start: 281
• Page End: 288
• Publication Date: 2014-12
• Subjects: Budapest Working Group -- Clinical study report -- Clinical study protocol -- ICH E3 -- ICH E6 -- Regulatory guidance -- Reporting -- Responsible clinical trial data sharing; Medical writing -- Periodicals; 808.0666105
• DOI: 10.1179/2047480614Z.000000000254
• Languages: English
• ISSNs: 2047-4806

Abstract

Abstract : International Conference on Harmonisation (ICH) E6 and ICH E3, developed nearly 20 years ago, are the current regulatory guidance documents for developing clinical study protocols (CSPs) and clinical study reports (CSRs). Ambiguity in the guidelines, and recent public disclosure requirements mean that review and revision of these guidelines is warranted. In May 2014, EMWA assembled a group of experts, called the Budapest Working Group (BWG), and initiated a 2-year collaboration with a variety of stakeholders to review the two guidelines. The resulting recommendations should address the needs of the widest possible community; incorporate developments since the guidelines were first issued; and facilitate responsible clinical trial data sharing. In this first of three planned open-access publications, we explain the objectives of this project, present our 2-year project plan, and report on progress to date.