Gallin and Ognibene's Principles and Practice of Clinical Research

Gallin and Ognibene’s Principles and Practice of Clinical Research, 5th Edition is the definitive text on clinical research, written by internationally recognized experts in their field, from the US National Institutes of Health, the US Food and Drug Administration, academia, and global researchers. The new edition contains fully updated chapters, with more than 50 new authors and 15 new chapters. The book continues a strong emphasis on study design and biostatistics in clinical research, with new chapters containing fresh information on a variety of topics, including chapters on how to engage a full range of research participants and research opportunities for people involved in patient care including surgeons, pharmacists, and other clinical researchers. For the international researcher, two new chapters detail international clinical research experiences in South Africa and India. As with the 4th edition, the new edition provides readers with summary questions and answers after select chapters.

• Study design considerations
• Statistical concepts relevant to clinical research
• Patient and community engagement
• Engagement of patient advocacy and rare disease organizations
• Preparation for clinical research during public health emergencies
• Incorporation of clinical outcome assessments into endpoints for decision-making
• Research opportunities for clinical researchers in various medical fields
• Written and edited by experts in the field and dedicated to facilitating the translation of scientific research from bench to bedside and back
• Incorporates new and updated chapters on global clinical research topics