During the last five years, clinical research and development costs have risen exponentially without a proportionate increase in the number of new medications. While patient recruitment for clinical studies is only one component in the development of a new medicine or treatment, it is one of the most significant bottlenecks in the overall drug development process. Now it is imperative that industry leaders see beyond reactive measures and recognize that advancing their approach to patient recruitment is absolutely essential to advancing medicine and continuing the stability of their corporate brand across the globe. Reinventing Patient Recruitment: Revolutionary Ideas for Clinical Trial Success is a definitive guide to planning, implementing and evaluating recruitment strategies and campaigns globally. The combined experience of the authors provides a depth of perspective and boldness of innovative leadership to set the standards for future patient recruitment programs and practices. This book is a must-have for pharmaceutical, biotechnology and medical device industry professionals concerned with enrolling for domestic and multinational clinical studies and remaining on time and on budget.
Table of Contents
Contents: Foreword. Part One Getting Started: Putting the patient first; Planning your study: Think communication; Applied metrics: Projecting enrollments; Picking good sites; Budgeting and contracting for patient recruitment. Part Two Development and Implementation: The importance of patient protections; Targeting the right patients; Site enrollment support; Metrics for evaluation and redeployment; Patient retention. Part Three Going Global: The changing landscape of multinational clinical studies; Approaching ethics committees: Perspective and opportunity; Selecting countries, sites and tactics that work. Part Four Future Trends: Personalized medicine and biotechnology; Public perception and industry leadership. Appendices: Good Recruitment Practice: The Patients to Find the Cure; Clinical Research Coordinator Survey 2003; The Will and Why Survey 2001; The International Will and Why Survey 2004; Ethics Committee Survey 2005. Glossary; Index.
Joan F. Bachenheimer and Bonnie A. Brescia are co-founders of BBK Worldwide, a full-service patient recruitment planning and implementation company for the clinical R&D segment of the pharmaceutical, biotechnology, and medical device industries. BBK Worldwide has helped to accelerate time to market for new medicines and treatments by successfully supporting hundreds of clinical studies in more than 60 countries, and in all major therapeutic areas. With more than 20 years of industry knowledge and experience to draw on, the authors have continually contributed ideas that accelerate and advance the clinical development cycle.
'This text provides everything we need to effectively develop successful enrollment strategies, including the metrics, tools and processes for single country or multinational clinical trials. It's a very thorough road map. We need only to follow it and ensure we show appreciation and respect to the thousands of heroic patients and families who volunteer to be our partners in the advancement of healthcare.' - From the foreword by Jim Kremidas, Global Enrollment Optimization, Eli Lilly and Company