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Statistics in Harmony: The Role of Estimands in Regulatory Writing

February 25, 2019 | Cheryl Ainslie, PhD, Clinical Research Scientist II | Regulatory Affairs Services

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In a previous post, I summarized the process by which the International Council for Harmonisation (ICH) creates harmonized guidelines for use by the pharmaceutical industry. Among the guidelines currently undergoing revision through this process is Efficacy (E) 9, Statistical Principles for Clinical Trials, which was initially released in February 1998. According to ICH, “This biostatistical Guideline describes essential considerations on the design and analysis of clinical trials, especially the ‘confirmatory’ (hypothesis-testing) trials that are the basis for demonstrating effectiveness.”

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Getting in Tune: The ICH Process of Harmonizing Guidelines

August 16, 2018 | Cheryl Ainslie, PhD, Clinical Research Scientist II  │ Regulatory Affairs Services

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“The only constant is change,” commonly attributed to the Ancient Greek philosopher Heraclitus, is as true today as it was in 500 BCE.  In the global industry of drug development, the conduct and reporting of clinical trials may change to a small degree with every new study proposed.  But what happens when there is growth or momentum for change that could impact the industry as a whole?

The Role of ICH

In a previous post, Ilana discussed the International Council for Harmonisation (ICH, previously called the International Conference on Harmonisation) guideline for clinical study report authoring, Efficacy Guideline 3 (E3).  The goal of the post you are reading is to take a step backward and explain how ICH guidelines are proposed, evaluated, and (possibly) adopted.  This process is key to understanding the function and operation of ICH to ensure that drug development is highly efficient and scientifically sound.

Created in 1990, the ICH of Technical Requirements for Pharmaceuticals for Human Use comprises experts from regulatory authorities and the pharmaceutical industry in the EU, US, and Japan.

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