Essential Resources on Health and Wellness from DiaMedica Publications

Cancer Clinical Trials

A Commonsense Guide to Experimental Cancer Therapies and Clinical Trials
Tomasz M. Beer, M.D., and Larry W. Axmaker, Ed.D.

Publication Date: April 2012
Price: $16.95
ISBN 13: 978-0-9823219-7-3
Trade Paperback: 192 pages
Size: 6 x 9 inches

Cancer Clinical Trials is the definitive guide for anyone considering therapeutic options in addition to standard cancer therapy. It will help readers decide if a clinical trial is a good option for them, to choose an appropriate trial, and to navigate through the clinical trial process. The book includes lists of questions to ask, things to look for, things to watch out for, and places to look for information.

It is written in the context that cancer treatment can broadly be divided into two broad categories: standard care, which involves regular, approved treatments, and experimental or investigational therapy, which involves participating in a clinical trial.

The book begins with a discussion of what cancer is and the many ways in which it is treated—including surgery, chemotherapy, radiation, and new strategies now in use or that will be available in the near future. It considers all aspects of clinical trials, including how they are designed, how to find and evaluate them, how to become a participant, and details of what they will involve in terms of time and commitment. A chapter on available drugs now used to treat cancer will be especially helpful.

If you are reading this book, you probably fall into one of these groups:
• You have cancer and are seeking something more, and a clinical trial might just be what you are looking for,
• You know someone who could use the information to make an important choice in his or her life, or
• You’re a doctor or a health professional who can educate and help guide patients through the decision to consider a clinical trial.

The companion blog to Cancer Clinical Trials, Cancer Clinical Trials, provides up-to-date information about ongoing and completed trials, experimental therapies, and other information of interest to everyone concerned with clinical trials.

ABOUT THE AUTHORS

Tomasz M. Beer, M.D., is a medical oncologist who leads a research and clinical trial program at Oregon Health & Science University in Portland, Oregon. He has been directly involved in over 100 clinical trials and has treated many hundreds of cancer patients. He has led trials at all phases, including those that use a medication previously only tested in animals for the first time in people, as well as large international trials that compare treatments to each other that, when successful, change the standard of cancer care.

It is Tom’s hope that this book will help readers enter into the often mysterious world of clinical trials armed with information and well prepared to make needed decisions.

Larry W. Axmaker, Ed.D., is a retired psychologist, teacher, and writer who has cancer and has participated in several clinical trials. He recently published a book about prostate cancer, Real Men Get Prostate Cancer, Too that chronicles his sometimes serious, sometimes humorous journey with his cancer.

CONTENTS

INTRODUCTION
How should you use this book?
An overview of core concepts in clinical trials

1. What is Cancer and how is it treated?

WHAT ARE CLINICAL TRIALS AND HOW ARE THEY ORGANIZED?
2. What is a clinical trial?
3. The types of clinical trials: Four phases and more
4. Randomized trials and placebos
5. Clinical trials that have changed cancer care

DECIDING WHETHER TO PARTICIPATE IN A CLINICAL TRIAL
6. Is there a clinical trial that’s right for me?
7. Who is looking out for you, and what can you expect?
8. Who pays for clinical trials, and what can they cost?

MEDICAL TREATMENT OF CANCER NOW AND IN THE FUTURE
9. Cancer drugs currently in use and being tested in trials
10. The future of cancer treatments and clinical trials: Personalized medicine

A final word
Tell us what you think
Glossary
Resources

Praise for Cancer Clinical Trials…

Cancer Clinical Trials: A Commonsense Guide to Experimental Cancer Therapies and Clinical Trials is a remarkably understandable, practical and thorough guide for cancer patients and their families and advisors. The book is also an excellent resource for clinical research professionals tasked with explaining such notoriously complex research.” — Journal of Clinical Research Best Practices
The Journal has also selected the book for The First Clinical Research Bookshelf, which consists of essential reading for clinical research professionals.

This book provides clear guidance to those contemplating participating in a clinical trial. It lays out the facts in easy to understand language. The book avoids using too much medical jargon and when it does, the definitions are in the glossary. It is designed with the lay person in mind. Also the book size is not intimidating as many medically focused books can sometimes be.” —Amazon*****

Being diagnosed with cancer can be a frightening experience that leaves one lost in a strange landscape of unfamiliar tests, big words, and bigger choices. Drs. Beer and Axmaker provide a road map that not only guides the reader through the complex twists and turns of cancer diagnosis and treatment, but empowers patients and family members to ask informed questions and make informed decisions about cancer clinical trials…. Every cancer patient interested in a clinical trial should understand the key concepts outlined in this book. The authors explain complicated technical terms and procedures in simple, clear language and take away some of the anxiety associated with the unknown.” — Amazon*****

This is a solid navigation tool for anyone interested in cancer clinical trials. Over my years as a prostate cancer patient advocate, the most confusing and daunting task has been helping guide patients toward understandable resources about clinical trial information they may research and discuss with their doctor. This book will take all of the mystery out of the process.” — Amazon*****

This book, co-authored by a renowned oncologist and a mature psychologist and cancer survivor, offers the reader much information about cancer clinical trials. They explain in lay people’s language many technical and complicated issues associated with cancer and its treatments, including its psychological and financial implications. This book is a “must,” not only for a cancer patient but also for his/her family members and family doctor.” — Amazon*****

This is a valuable resource for adult cancer patients. It clearly describes the clinical trial process and how a clinical trial may be beneficial…. It is easy to read and understand and useful for any patient who may benefit from being involved in a clinical trial.” — Doody’s ****

Cancer Clinical Trials is a straightforward and plain language guide to the potentials of cancer treatment and how to better understand the process to find the correct treatment for the individual cancer case. The [authors] elaborate further on the latest research and what must be considered for one considering all options. Cancer Clinical Trials is a strong pick for those who want to better understand all the potential solutions for treatment.” — Midwest Book Review

This is one of the best books I’ve read that demystifies the complex world of cancer clinical trials. This is the one book that any patient contemplating entry into a clinical trial should read. It clearly demonstrates the value of clinical research, without overwhelming the reader who is already dealing with difficult medical issues.” — Bill Bro, Kidney Cancer Association Chief Executive Officer

Francis Bacon’s adage, “Knowledge is power,” could not be more true when it comes to cancer treatment and the decision to participate (or not) in a clinical trial. Drs. Beer and Axmaker offer a guided tour of the clinical trial process, providing a view afforded to few who have not “been there, done that.” In doing so, they decipher jargon and debunk myths, empowering patients to make more informed decisions. Setting the stage with the basics of cancer therapy and a brief history of clinical trials, the book moves quickly to the practical issues of finding a clinical trial and navigating the clinical trial system. I want all my patients (and all my trainees) to read this book.” — Kathy D. Miller, MD, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

Clinical trials have contributed enormously to the recent rapid advances in cancer therapy. Unfortunately, too few patients are told about all the available options. Improved communication—especially via the Internet—is leading to much greater awareness. This book fills the need for a thorough yet plain-language guide explaining the benefits (and also the risks) of clinical trial participation. In addition, the authors provide a valuable and up-to-date overview of cancer treatment, including all the major modalities: surgery, radiation, chemotherapy, the newer targeted therapies, and immunotherapy. They also consider important practical issues such as costs, insurance coverage, regulatory oversight, and the use of placebos. Cancer Clinical Trials is a welcome addition to the literature available to cancer patients who want to explore all practical options for ensuring that they get the best therapy possible, and for accelerating research toward new cancer cures.” — David Josephy, President, GIST Sarcoma Life Raft Group Canada

…will be valuable for patients and their family members and friends facing a battle with cancer as it can inform and empower people to seek the best care available. In a straightforward manner, it not only outlines what cancer is and how treatment is approached now and will be in the future, it shares how treatments are moved forward through experimentation in clinical trials. It provides helpful suggestions on how to find and benefit from such trials and address challenges one might have in the search. Dialogue and communication between patient and doctor is so essential, this book can inform patients and promotes informed discussion and involvement.” — Thomas N. Kirk
President and CEO, Us TOO International Prostate Cancer Education and Support Network

Being diagnosed with cancer can be a frightening experience that leaves one lost in a strange landscape of unfamiliar tests, big words, and bigger choices. Drs. Beer and Axmaker provide a road map that not only guides the reader through the complex twists and turns of cancer diagnosis and treatment, but empowers patients and family members to ask informed questions and make informed decisions about cancer clinical trials. This commonsense guide draws on a wealth of knowledge and experience from both authors: one an experienced clinical physician who has run many clinical studies for cancer, the other an articulate traveler on the road of cancer diagnosis, who has been treated on many cancer clinical trials.

Every cancer patient interested in a clinical trial should understand the key concepts outlined in this book. The authors explain complicated technical terms and procedures in simple, clear language and take away some of the anxiety associated with the unknown.” — James L. Gulley MD, PhD, FACP, Director, Clinical Trials Group, National Cancer Institute

In this groundbreaking new book, Tomasz M. Beer, MD, an internationally admired leader in cancer clinical trials and a sterling clinician, has joined forces with Larry Axmaker, EdD, a cancer patient and clinical trials participant, to present a powerful, practical, and accessible account of how to navigate cancer clinical trials. In addition to providing a detailed assessment of the various risks and benefits associated with participation in cancer clinical trials as well as insight into how clinical trials are designed and run, the book features “bottom line” sections at the end of each chapter that succinctly summarize the important take-away issues that patients should consider.

These sections form a useful framework from which patients can make informed decisions or engage their doctors with key questions. In empowering patients to act thus as partners in medical research progress, this timely book illustrates how clinical trials are critical to improving the standard of cancer care. For anyone affected by cancer such as patients, health professionals, families, caregivers, and loved ones, Cancer Clinical Trials: A Commonsense Guide to Experimental Cancer Therapies and Clinical Trials should be required reading.” — Jonathan W. Simons, MD, President and CEO, David H. Koch Chair of the Prostate Cancer Foundation

…[a] well-balanced explanation on every aspect of clinical trials does, I believe, alleviate the doubt and fear of cancer patients and motivate them to get involved in a clinical trial, which may benefit them in the first place and also other patients a little later. Written in plain, lay-people’s language, despite its content being highly scientific and technical, this book can be a good companion to family doctors as well as to their patients and families who are not yet sure of having clinical trials.” — Seiichi Ariga, PhD, United Church of Canada

…a thoughtful, easy-to-read guide to demystify the clinical trials process, [it] explains the risks and benefits, and educates patients about their role in this critically important endeavor….In a day and age when increasing pressure is placed on the patient to take control of his or her medical care, this guide provides understandable answers to potential trial participants’ most frequently asked questions, while debunking myths and providing pointers to additional sources of information. Clinical trial participation is a critical step on the road to finding a cure, and Dr. Beer and Dr. Axmaker have put together a guide that makes it possible for patients to put their best foot forward when making important treatment decisions.” — Skip Lockwood, President and CEO, ZERO – The Project to End Prostate Cancer

…a comprehensive and highly accessible resource for understanding modern cancer therapeutics. It explains beautifully the complex process of designing, undertaking and interpreting clinical trials in cancer. It does so in the wider context of understanding what elements are addressed in deciding what the best treatment is for any particular patient. Anyone faced with the diagnosis of cancer and hoping to understand how to navigate treatment in our modern age will find this book extremely valuable. I also feel this book should be read by medical and nursing students as a first rate introduction in the basics of both clinical trials and cancer therapeutics.” — Joseph T. Ruggiero, MD, Associate Professor of Clinical Medicine and Medical Director of the Solid Tumor Oncology Practice, Weill Cornell Medical College, New York

…brilliant in the easy way [this book] introduces patients to the pros and cons of participating in those much-needed studies…informs patients about how to find appropriate trials to participate in and what to expect from that experience…[an] easily accessible introduction to the breadth of treatments both currently available and in development…for patients who truly want others to benefit from their experience, ‹this is the book…” — Richard Wassersug, PhD, prostate cancer patient and researcher, Dept. of Urologic Sciences, University of British Columbia, Vancouver, Canada

…clearly written and quite understandable. [The book] lists the nuts and bolts behind how trials are done, why patients might (and should!) participate, and what they should ask their doctor, before , during, and after deciding and participating in a study. Ethical issues are covered delicately but appropriately. I cannot imagine a more useful book for anyone touched by cancer or who knows someone thinking about options.” — Charles D. Blanke, MD, FACP, FRCPC, Vice President, Systemic Therapy, British Columbia Cancer Agency and Professor and Head, Division of Medical Oncology, University of British Columbia, Vancouver, Canada

This book should be required reading for cancer patients and their family members for so many reasons. It not only discusses the current effective options, but also covers the potential breakthrough treatments in cancer that are happening right now, and it even provides expert guidance on the maze of health insurance issues that many cancer patients and their health-care professionals deal with today. Best of all, this book is not filled with confusing medical jargon, but rather provides an easy-to-understand guide to help you in the decision making process.” — Mark A. Moyad, MD, MPH, Department of Urology, University of Michigan Medical Center, Ann Arbor

As a cancer survivor, an oncologist, and a cancer advocate, I actively participate in a community of survivors and health care providers focused on issues of cancer in adolescents and young adults. Cancer among people in their teens, 20’s, and 30’s is not only the leading natural cause of death, but from the 1970’s through the 1990’s survival rates did not improve. Over the same period of time, cancer survival rates among young children did improve, dramatically, to now well over 80% at five years.

Why might that be? One glaring difference is the rate of participation in cancer clinical trials. The vast majority of children in the US receive their cancer care as part of a clinical trial. But the clinical trial participation rate among young adults is less than 5%. If we are to engineer improvements for this group, we must increase participation in cancer clinical trials.

Clearing up misconceptions about cancer clinical trials, and aiding patients as they decide about participation in cancer clinical trials, is critical to that work, and Cancer Clinical Trials is a valuable tool to guide people through this process. This book is both comprehensive and easy to use, with direct questions asked and answered, misconceptions you may encounter highlighted, and sample practical items like billing schedules and insurance letters provided. In the end, readers are invited to join the authors, and advocates like myself, into this cancer fighting community.” —
Brandon Hayes-Lattin, MD, Senior Medical Advisor, LIVESTRONG; Medical Director, Adolescent and Young Adult Oncology Program and Associate Professor of Medicine, Oregon Health and Science University, Knight Cancer Institute

Authors News

Tomasz Beer and Larry Axmaker sign copies of Cancer Clinical Trials at Powell’s bookstore in Portland.