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Trial Registration and Results Reporting in Public Clinical Trial Registries: Requirements and Practical Demonstration

Level:
Foundation
Area:
Drug Development
Code:
DDF49
Duration:
03:00:00
Workshop profile:
This Foundation workshop is intended for participants who wish to learn about the requirements, timings, and processes used for disclosure of clinical trial results in public databases in the USA (via ClinicalTrials.gov) and in the EU (via EudraCT). Previous experience in clinical trial registration and results disclosure is not required, but a working knowledge of and navigation through clinical study protocols and clinical study reports is advantageous.
Objective:
Upon completion of this workshop participants will: · understand the requirements for disclosure of clinical trial results in the US and EU, · be familiar with the content of both US and EU clinical trial results records, · understand the similarities and differences between the two databases, and · appreciate the importance of content consistency across clinical trial documents that reach the public domain.
Content:
The workshop will contain the following: i) introduce the legal regulations and non-legal requirements governing clinical trial disclosure registration (of new clinical trials) and summary results (for completed clinical trials) relevant for the US and EU regulatory authorities, ii) summarize the requirements and content of both the US and EU clinical trial summary results records, including practical tips on how to approach authoring of the results entries in each database, iii) live presentation of the database structure and study results entry into the databases (ClinicalTrials.gov and EudraCT), iv) illustrate, with practical examples, the need for content consistency with respect to Clinical Study Protocols, Clinical Study Reports, Plain Language (layperson) Summaries, and journal publications (including the requirements of the ICMJE for publication of results from interventional clinical trials in clinical/biomedical journals).