“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 National Institutes of Health, the US Food and Drug Administration, academia, and global researchers. The new edition contains fully updated chapters, more than 30 new authors, and 9 new chapters. The book continues a strong emphasis on biostatistics in clinical research with new chapters containing fresh information on a variety of topics, including new emphasis on the role of informatics in clinical research, incorporating clinical outcome assessment into endpoints for decision-making, inclusion of diverse and vulnerable research subjects, patient advocacy groups and rare disease research, preparing research for the next pandemic and clinical research during public health emergencies, research opportunities for surgeons, and for those in the preclinical space a new chapter on preclinical animal studies. For the international researcher, two new chapters detail international clinical research experiences in South Africa and India and Pakistan. As with the 4th edition the new edition provides readers with summary questions and answers after each chapter.

• Two new chapters detail international clinical research experiences in South Africa and India and Pakistan
• Written and edited by experts in the field and dedicated to facilitating the translation of scientific research from bench to bedside and back
• Contains fully updated chapters, more than 30 new authors, and 9 new chapters
• Provides expanded coverage of global clinical research including HIV and COVID