Professor Peter Kaufmann, PhD, FABMR, FSBM, associate dean for Research and Innovation at Villanova University M. Louise Fitzpatrick College of Nursing (FCN), has co-authored with Lynda H. Powell and Kenneth E. Freedland Behavioral Clinical Trials for Chronic Diseases (Springer), released September 2021. This is the first comprehensive book on basic principles in the design and conduct of behavioral randomized clinical trials (RCTs) for evaluating effectiveness of behavioral interventions for treatment and prevention of chronic diseases and their risk factors, such as obesity, psychosocial stress or fragmented care.
“Behavioral risk factors account for about half of all causes of chronic diseases in general and heart disease in particular, so developing evidence-based methods for their treatment and prevention is an important public health strategy,” notes Dr. Kaufmann. Innovation in clinical trial methods is necessary, not only from behavioral sciences but other disciplines such as nursing, medicine, epidemiology and biostatistics.
Behavioral Clinical Trials for Chronic Diseases sets a goal for rigor in behavioral RCTs akin to that of double-blind drug RCTs. Future-oriented, it blends experience from key behavioral trials and methods to provide a firm foundation for successful clinical trials.
Dr. Kaufmann has extensive experience in clinical trials through his career at the National Institutes of Health (NIH), with more than 30 years of experience in conducting multi-site clinical trials and teaching clinical trials methodology. He is well known for creating numerous large-scale research programs that pushed the boundaries of knowledge in disease prevention and understanding the impact of psychological and social risk factors on health. His notable studies include the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) clinical trial for treating depression in heart disease patients, the Trials of Hypertension Prevention (TOHP), and the Psychophysiological Investigations of Myocardial Ischemia (PIMI) study that delineated the role of mental stress as a factor in acute cardiac events.
Dr. Kaufmann is the founder of the renown NIH Summer Institute on Randomized Controlled Trials of Behavioral Interventions, which serves as a model for FCN’s Summer Institute on Randomized Clinical Trials to be held in the Summer of 2022. He is a principal investigator for FCN’s CHAMPS Study assessing the health effects of frontline service on health care providers, support personnel and first responders launched May 2020.