Drugs

General, Specific Comments on ICH Clinical Studies Guidance

Flatiron Health says it welcomes the revised International Council for Harmonization (ICH) E8(R1) guidance on general considerations for clinical trials, including changes that “recognize the increasingly important role a wider range of study designs and data sources can play in drug development.” The company comment says Flatiron particularly appreciates the clarity and considerations provided regarding data captured from electronic health records.

The Association of Clinical Research Professionals says the majority of the document could apply not only to pharmaceutical studies but also to investigational medical devices. And it says that while introduction of risk-based language and critical to quality factors is positively received by its reviewers worldwide, by being overly broad and allowing latitude interpretation, it may end up not being as useful as intended.

The Biotechnology Innovation Organization comments that the document should reset the framework for how drug development is approached to recognize the evolution of scientific methodologies. It also recommends that a glossary be added to clearly define terms used in the guidance, since some of them are new to ICH.

The Otsuka comment letter acknowledges FDA’s effort in revision of the guidance for internationally accepted principles and practices for the design and conduct of clinical studies of drug and biologic products. It says it supports the intent of the draft guidance to promote the quality of studies submitted to regulatory authorities.

Finally, Pharmaceutical Research and Manufacturers of America says it supports FDA and ICH efforts to promote international harmonization and update the guideline to address the more complex clinical trial approaches that are now being employed in drug development. The trade group says it believes the scope of the draft should not be limited to interventional studies but rather should encompass all studies of medical products in humans that meet the definition of “clinical study” as used in the draft guideline.

All five stakeholders also provided line-by-line specific comments, as did Medtronic, which did not include any general comments or overview.

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