Journal overview

This title has ceased (2017).

Clinical Research and Regulatory Affairs is a peer-reviewed international journal whose primary aim is the dissemination of knowledge about the issues and challenges of clinical research, with a special emphasis on the design, conduct, analysis, synthesis, history, ethics, regulation, and clinical and policy aspects of drug development. The journal is committed to the rapid communication of original, scientific, and statistically significant results that pertain to advancements in clinical research and regulatory approaches appropriate for advancing drug development. Each issue will provide in-depth analyses of a key problem area in developing a regulatory initiative.

The scope of Clinical Research and Regulatory Affairs includes methods for designing, analyzing, and interpreting scientific research results and harmonizing drug development. The journal invites these discussions in the form of original articles, comprehensive commentaries, or in-depth reviews of research methodologies that explore the evolving paradigm for regulating drug and biological products.

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