04/12/2022
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Clinical trial design and conduct have become more complex, impacting the time and cost required to develop drugs. ICH E8(R1) is intended to address the concerns about the principles of trial design and planning that are needed to ensure an appropriate level of data quality. The revision incorporates current concepts, including fit-for-purpose data quality, as one of the essential considerations for all clinical trials. It expands the idea of a proportionate approach to trial design and conduct and the process of focusing on the items that are critical to the quality of the trial - the protection of participants and the reliability of the data - to ensure that the results are quality enough to support good decision making. The focus is not on the perfection of results but the assurance of quality.
ICH E8(R1) is the umbrella guideline that maps to all the ICH “E” family, including ICH E6(R3), Good Clinical Practice. The revision modernizes clinical trial design, planning, management, conduct, and reporting and introduces the idea of quality as data being fit for purpose, which is ensuring the protection of study participants, the integrity of the data and reliability of the results, and the ability of the trials to meet their objectives. The key purpose is to design quality into clinical trials, which is supported by the establishment of an appropriate framework for the identification and review of Critical to Quality factors at the time of design and planning of the study, and throughout its conduct, analysis, and reporting.
Most other countries who are International Council for Harmonisation (ICH) Members or Observers implement ICH guidelines into their regulations, but the US Food and Drug Administration (FDA) releases them as guidance. The “E8(R1) General Considerations for Clinical Studies” FDA guidance, released April 2022, is available HERE.
Clinical Pathways offers an interactive eLearning course that covers why a revision to ICH E8 was needed, overarching themes of changes, the introduction of Quality by Design and Critical to Quality applied to clinical trials, an overview of the sections of the Guideline, with assessments of knowledge and a scenario.
A demo of the course and the link to purchase is available HERE.
Learning Objectives
1. Recognize how ICH E8(R1), the Guideline for General Considerations for Clinical Studies, has changed organizational processes.
2. Apply the Guideline to key concepts in clinical trials.
3. Discuss implementation challenges and opportunities regarding the updates in the Guideline.
Customization Available
A fully customized course can be developed for training teams, or for live in person or online workshops. Full LMS compatibility with SCORM packages available. Contact us at info@clinicalpathwaysresearch.com for additional information or to arrange a meeting to discuss.
- The Clinical Pathways Team
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