Essential CNS Drug Development

Amir Kalali is Vice President, Medical and Scientific Services, and Global Therapeutic Team Leader (CNS) at Quintiles Inc. He is also Professor of Psychiatry at the University of California San Diego, San Diego, CA, USA. Sheldon Preskorn is Professor and Chairman, Department of Psychiatry and Behavioral Sciences, University of Kansas School of Medicine, Wichita, KS, USA. Joseph Kwentus is Clinical Professor at the University of Mississippi Medical Center, Jackson, MS, USA. Stephen M. Stahl is Adjunct Professor of Psychiatry at the University of California San Diego, San Diego, and the Neuroscience Education Institute, Carlsbad, CA, USA.

'The experienced authors admirably describe the art and skills of managing the constraints of recruitment criteria, prioritising participant welfare, and balancing budgetary concerns … The volume can be recommended for the libraries of senior investigators who are training the next generation as a stimulus in the supervisory process. The text also offers a springboard for discussions among policy makers themselves, hopefully promoting an insight that they are overdue in their effort to overhaul a system nearly imploding under ponderous, regulatory, protectionistic, and, unfortunately, often minimally scientific burdens of multiple financial and other interests. The brief format is highly readable, more concise than comprehensive in scope, providing more of an overview of the issues than would be expected from a formal reference text … Overall, the editors offer a timely discussion of many strengths and weaknesses of a highly regulated and cumbersome process.' Ronald M. Salomon, Journal of Clinical Psychiatry

• Preface; 1. History of CNS drug development Sheldon H. Preskorn; 2. Regulatory issues Gwen L. Zornberg; 3. Pre-clinical development Alan J. Cross and Frank D. Yocca; 4. Phase I trials: from traditional to newer approaches Matthew Macaluso, Michael Krams and Sheldon H. Preskorn; 5. Phase II development and the path to personalized medicine in CNS disease Douglas E. Feltner and Kenneth R. Evans; 6. CNS drug development – Phase III Judith Dunn, Penny Randall and Amir Kalali; 7. Statistics issues relevant to CNS drug development Craig H. Mallinckrodt, William R. Prucka and Geert Molenberghs; 8. Clinical trials management at company level Nuala Murphy; 9. Clinical trials management at the site level Joseph Kwentus; 10. Medical writing for CNS indications Ginette Nachman; 11. Dissemination of clinical trial information: multiple audiences, multiple formats Leslie Citrome; 12. The importance of treating cognition in schizophrenia and other severe mental illnesses: background, strategies, and findings to date Philip D. Harvey and Richard S. E. Keefe; 13. Leveraging disruptive technologies to drive innovation in CNS clinical drug development Penny Randall, Judith Dunn and Amir Kalali; Index.