Main description:

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.

Contents:

Preface by Dr. Mark PegramChapter 1: Why I Wrote This BookChapter 2: Understanding Clinical TrialsChapter 3: Oversight of Clinical TrialsChapter 4: Ethical Conduct of Clinical TrialsChapter 5: Assessing Risks Versus BenefitsChapter 6: Some Additional Considerations For You As A Research SubjectChapter 7: The Physician - The Role of the Clinical InvestigatorChapter 8: The Drug Development ProcessChapter 9: Gene Transfer Clinical Research and Other Experimental ApproachesChapter 10: Clinical Trials Involving the ElderlyChapter 11: Clinical Trials Involving ChildrenChapter 12: Clinical Trials Involving Rare or Orphan DiseasesChapter 13: Clinical Trials Involving Disabled And Vulnerable GroupsChapter 14: Some Helpful ResourcesChapter 15: Final ThoughtsGlossary of Terms and Jargon