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International Clinical Trials

Strategic Success

ICT: With the addendum to the ICH E6 (R2) Guideline for Good Clinical Practice (GCP), the GCP has seen its first significant update in over 20 years. What is the new guideline and how does it impact clinical trial design?

Patrick Hughes: The ICH GCP Guidance Integrated Addendum provides a unified standard for the EU, Japan, the US, Canada, and Switzerland. The updated ICH E6 (R2) guidelines have been introduced to encourage the implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, while continuing to ensure human subject protection and reliability of trial results. Far from being considered a hurdle to overcome, the ICH E6 (R2) should be a positive step forward and an exciting opportunity for more efficient clinical R&D, with significantly better outcomes.

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Patrick Hughes is the Chief Commercial Officer at CluePoints. He holds a marketing degree from Newcastle University, UK, and a postgraduate marketing diploma in B2B marketing strategy from the Kellogg School of Management, US. Responsible for leading global sales, product, marketing, operational, and technical teams throughout his career, Patrick is a Senior Executive with over eighteen years of international commercial experience within life sciences, healthcare, and telecommunications.
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