Clinical Trials: What Patients and Volunteers Need to Know

Paperback | August 13, 2010

byLorna Speid

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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 collegetuition, 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 ofbewilderment 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 definitionsand 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 resourcefor 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.

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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 collegetuition, or they may know someone who is suff...

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...
Format:PaperbackDimensions:208 pages, 5.39 × 8.11 × 0.59 inPublished:August 13, 2010Publisher:Oxford University PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:019973416X

ISBN - 13:9780199734160

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Table of Contents

Dr. Mark Pegram: Preface1. Why I Wrote This Book2. Understanding Clinical Trials3. Oversight of Clinical Trials4. Ethical Conduct of Clinical Trials5. Assessing Risks Versus Benefits6. Some Additional Considerations For You As A Research Subject7. The Physician - The Role of the Clinical Investigator8. The Drug Development Process9. Gene Transfer Clinical Research and Other Experimental Approaches10. Clinical Trials Involving the Elderly11. Clinical Trials Involving Children12. Clinical Trials Involving Rare or Orphan Diseases13. Clinical Trials Involving Disabled And Vulnerable Groups14. Some Helpful Resources15. Final ThoughtsGlossary of Terms and Jargon