Clinical Trials: What Patients and Volunteers Need to Know

Overview

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. ...

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Clinical Trials: What Patients and Volunteers Need to Know

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Overview

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.

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Editorial Reviews

Publishers Weekly
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.)
Doody's Review Service
Reviewer: Vincent F Carr, DO, MSA, FACC, FACP (Uniformed Services University of the Health Sciences)
Description: This book is primarily for laypeople who are considering volunteering for a clinical trial. It is written by a clinical trial coordinator after her experiences working with oncologists and their clinical trials.
Purpose: The author explains that she has observed many volunteers with numerous questions about clinical trials and this is her way of answering these and other questions so that volunteers may make informed decisions. She succeeds quite well and adds the perspective of someone who has not been instilled from the start with the perspective of the National Institutes of Health. As such, she has a slightly different approach that adds considerable readability and perspective.
Audience: While this is intended for prospective volunteers, the book has tremendous utility for those conducting clinical trials who might want to look at some of the issues from the volunteers' viewpoint.
Features: The book is a series of stories through which the author develops and solidifies her points, resulting in a highly useful, easily understood book of background information for volunteers.
Assessment: As it does not follow the usual pattern of explaining human volunteer regulations, 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.
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Product Details

  • ISBN-13: 9780199734160
  • Publisher: Oxford University Press, USA
  • Publication date: 7/30/2010
  • Pages: 208
  • Sales rank: 1,275,496
  • Product dimensions: 8.10 (w) x 5.40 (h) x 0.60 (d)

Meet 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.

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Table of Contents

1 Why I Wrote This Book 3

2 Understanding Clinical Trials 7

3 Oversight of Clinical Trials 13

4 Ethical Conduct of Clinical Trials 21

5 Assessing Risks versus Benefits 33

6 Other Issues to Consider as a Research Subject 51

7 The Role of the Clinical Investigator 59

8 The Drug Development Process 71

9 Gene Transfer Clinical Research and Other Experimental Approaches 91

10 Clinical Trials Involving the Elderly 105

11 Clinical Trials Involving Children 113

12 Clinical Trials Involving Rare or Orphan Diseases 125

13 Clinical Trials Involving Disabled and Vulnerable Groups 133

14 Some Helpful Resources 141

15 Final Thoughts 155

Glossary 159

Index 181

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