Clinical Trials

Every year, hundreds of thousands of healthy volunteers and patients worldwide undertake the journey through the maze that can be clinical trials. Research participants take part in clinical trials for a variety of reasons. The healthy volunteers may be seeking extra money to pay off college tuition, or they may know someone who is suffering and would potentially benefit from the results of the trial. The patient who is terminally ill might participate in a clinical trial simply as a last hope for a cure. Whatever the goals, though, most participants will experience the same sense of bewilderment as they encounter the jargon and medical terminology that they will hear and have to read about and understand during the course of the clinical trial. Clinical Trials: What Patients and Volunteers Need to Know demystifies the entire process, focusing on the process of drug development, and the clinical trial itself. Writing from a lifetime of experience, the author provides important questions to ask those running a clinical trial, key definitions and terms for a participant to know and understand, as well as anecdotes illustrating the clinical trial process. The author also grapples with the idea of "informed consent," providing mechanisms for patients and volunteers to feel fully informed before signing up for the trial. A vital resource for those who are considering enrolling in a clinical trial, or for the parents, friends, or relatives of those involved in a clinical trial, this book takes away the mystery and allows the participant to enter a clinical trial feeling both informed and confident.

Lorna Speid, B.Pharm, MRPharm.S., Ph.D., RAC, is the president of Speid and Associates, Inc., a regulatory affairs and drug development consultancy. Dr. Speid has worked for the international pharmaceutical industry since the late 1980s. In addition to her work as a consultant, her earlier research and clinical trial experience in the pharmaceutical industry has given her invaluable insight into the issues faced by patients and healthy volunteers who take part in, or are considering taking part in, clinical trials. She lives in San Diego.

Preface by Dr. Mark Pegram Chapter 1: Why I Wrote This Book Chapter 2: Understanding Clinical Trials Chapter 3: Oversight of Clinical Trials Chapter 4: Ethical Conduct of Clinical Trials Chapter 5: Assessing Risks Versus Benefits Chapter 6: Some Additional Considerations For You As A Research Subject Chapter 7: The Physician - The Role of the Clinical Investigator Chapter 8: The Drug Development Process Chapter 9: Gene Transfer Clinical Research and Other Experimental Approaches Chapter 10: Clinical Trials Involving the Elderly Chapter 11: Clinical Trials Involving Children Chapter 12: Clinical Trials Involving Rare or Orphan Diseases Chapter 13: Clinical Trials Involving Disabled And Vulnerable Groups Chapter 14: Some Helpful Resources Chapter 15: Final Thoughts Glossary of Terms and Jargon