What's the best way to get started in clinical trials? How do I recruit volunteers? How do I traverse the ethical and political issues involved in conducting drug trials today? With the tremendous demand for clinical investigators--thousands of new investigators are needed in the United States alone--the answers to these questions is vital. Dr. Judy Stone answers these questions and more in this experienced and successful first-hand "view from the trenches." The book reveals the minefields and booby traps to avoid when entering this field, summarizes the drug development process, describes the complexities of the multiple disciplines and people that need to come together to successfully bring a drug through trial, FDA approval and to market. The book details the best practices involved in carrying out a study from landing your first study and negotiating with a drug company to recruiting and treating volunteers. Other topics include new regulations affecting research, subject injury clauses, legal and publication land mines, the unique needs of device and vaccine trials, cultural competency and health literacy, the impact of HIPAA on U.S. research, and how to survive audits.

"Successfully covers . clinical trials. Practical considerations . substantial background and resource information . fills an important need." Annals of Internal Medicine.