Synopses & Reviews
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.
There's a lot to know about the hugely important clinical trials of drugs that aim to ease or cure the most vexing diseases from a trial's medical and ethical oversight to the source of funding the qualifications of the investigators possible conflicts of interest and risks. For anyone considering entering a clinical trial it's worth bearing with the dry dense delivery here (aided by case studies) because of the rich information. Speid a 30 year veteran of the pharmaceutical industry wades into the labyrinth of the drug development process the complexities of trials involving children the elderly and the disabled; the special safety issues in experimental approaches like gene transfer; and the importance of grilling the doctor running the research to get a full understanding of the trial. Still the most powerful message is the simple wisdom of not going it alone: advocates should be enlisted from a hospital church law firm or family to represent the participant's interests. Also useful though ploddingly redundant are questions Speid provides for each trial step and Web links for exploring a process so fraught with hope for its participants and all those who may benefit from its results. (Aug.) " Publishers Weekly Copyright PWxyz, LLC. All rights reserved."
"There's a lot to know about the hugely important clinical trials of drugs that aim to ease or cure the most vexing diseases-- from a trial's medical and ethical oversight to the source of funding, the qualifications of the investigators, possible conflicts of interest, and risks. For anyone considering entering a clinical trial, it's worth bearing with the dry, dense delivery here (aided by case studies) because of the rich information. Speid, a 30-year veteran of the pharmaceutical industry, wades into the labyrinth of the drug development process, the complexities of trials involving children, the elderly, and the disabled; the special safety issues in experimental approaches, like gene transfer; and the importance of grilling the doctor running the research to get a full understanding of the trial. Still, the most powerful message is the simple wisdom of not going it alone: advocates should be enlisted from a hospital, church, law firm, or family to represent the participant's interests. Also useful, though ploddingly redundant, are questions Speid provides for each trial step, and Web links for exploring a process so fraught with hope for its participants--and all those who may benefit from its results. (Aug.)" Publishers Weekly (Copyright PWyxz LLC)
"...this is a refreshing and tremendously useful book, with stories from a coordinator who has worked within the system and understands the limitations of volunteering for clinical trials. I highly recommend this to every researcher." --Doody's
About the Author
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.
Table of Contents
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