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Webinar to Provide Findings & Reflections from CTTI’s ICH E6 Renovation Work

As the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) begins revisions to ICH E6 GCP, new CTTI research highlights opportunities for changes and improvements.

 

CTTI will host a webinar Thurs., March 19, at noon ET providing an overview of new multi-method research to identify areas within ICH E6 GCP that are in the greatest need of renovation. Speakers will include:

 

  • Fergus Sweeney (EMA)
  • Celia Witten (FDA, CBER)
  • Amy Corneli (CTTI)
  • Dagmar Gortz (Janssen)
  • Pamela Gonzalez (University of Chicago)

CTTI’s research includes the perspectives of more than 350 research professionals in 20 different global regions and describes stakeholder experiences with implementing ICH E6 GCP. Preliminary findings were presented to the FDA and EMA in advance of the first ICH E6 work group meeting in November 2019. Some of the initial findings include:

 

  • 32.4 percent of respondents use mobile applications for the remote capture of efficacy or safety outcomes data for regulatory decision making
  • 62.1 percent use routine health care data for capture of efficacy or safety outcomes data for regulatory decision making
  • 60-75 percent of survey respondents indicated that renovation is not needed to the general principles
  • Areas identified as needing the most renovation included: Sponsor, Essential Documents, and Investigator. Of less need for renovation were topics in the section on Clinical Trial Protocol and Protocol Amendments.

To hear more, mark your calendar for the upcoming webinar today!