We are excited to announce the release of book in collaboration with our Department, “Clinical Trials: Practice, Law, Ethics.”

This comprehensive book offers a wide range of specific information and interdisciplinary knowledge pertinent to the conduct of clinical trials. It covers topics from the history of bioethical issues to strictly operational matters, and delves into the latest regulations in Poland and the EU. The updated edition introduces new chapters focused on data management, biostatistics, personal data protection, collaboration with patient organizations, and research during crises like wars or pandemics.

The chapter “The Role of Biostatistics in Planning and Analyzing Clinical Trial Results,” authored by i.a. Prof. Wojciech Fendler, MD, Arkadiusz Michalak, MD, and Joanna Piwnik, MSc Eng, provides an in-depth exploration of biostatistics for clinical trials. It covers everything from the planning stages and preparation of statistical analysis plans, to different trial designs, including superiority/non-inferiority and adaptive trials, as well as practical aspects of statistical analysis in line with international harmonization standards.

You can purchase the book through this link: Clinical Trials: Practice, Law, Ethics.


“Clinical Trials: Practice, Law, Ethics” – A Collaborative Effort with Our Department!
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