I have just written a book titled Cancer Clinical Trials: Experimental Treatments & How They Can Help You, which was published in September 1999 by O'Reilly and Associates as part of their Patient-Centered Guides series. The book is available for purchase at Amazon.com. Cancer Clinical Trials tells you everything you need to know about finding and evaluating experimental cancer treatments. While I don't recommend any specific treatments, I believe that everyone with a diagnosis of cancer owes it to themselves to evaluate available clinical trials along with their other treatment options.

Public and Media Appearances

In December 1999 health insurers in New Jersey voluntarily agreed to cover the routine costs of medical care for members enrolled in cancer clinical trials. I wrote an op-ed piece about this, which appeared in the San Francisco Chronicle: "N.J. Health Insurers Offer a Laudable Model For Covering Some Costs of Cancer Clinical Trials: Move should increase participation, hasten pace of research" San Francisco Chronicle, January 6, 2000, p. A21

Table of Contents

Foreword
Robert Bazell honored me by writing the book's foreword. In addition to serving as chief science correspondent for NBC News, Bazell is the author of an excellent account of the development of a promising new treatment for breast cancer.

Robert Bazell, Her-2: The Making of Herceptin, a Revolutionary Treatment for Breast Cancer, (New York: Random House, 1998) 214 pp.
Order Her-2

Preface

Chapter 1 -- Overview of Clinical Trials
This chapter first describes in general terms what a clinical trial is. After looking at reasons people don't participate in trials, we state the reasons why you should at least consider available clinical trials, as part of your decision making about cancer treatments. The chapter closes with a short discussion of traditional and alternative or complementary medicine.

I recomend that anyone with cancer read as much as they can about their illness. One of the best general references about the many different types of cancer and the various treatment options is:

Gerald P. Murphy, M.D., Lois B. Morris, and Dianne Lange, Informed Decisions: The Complete Book of Cancer Diagnosis, Treatment, and Recovery, (New York: Viking Penguin Books, 1997), 689 pp.
Order Informed Decisions

Michael Lerner's excellent book, Choices in Healing: Integrating the Best of Conventional and Complementary Approaches to Cancer (MIT Press, 1994, 667 pp.) gives a thorough overview of integrating conventional and complementary approaches to cancer treatments. You may order it from Amazon.com, but it's also available on the web in its entirety.

Chapter 2 -- The Structure of Clinical Trials
This chapter describes the typical sequence of events involved in taking a new treatment from the laboratory to general use. It discusses Phase I, Phase II, Phase III, and Phase IV trials, and lists the plusses and minuses of each phase. It also discusses the important issues of placebos and randomization.

Two good books on placebos are: Arthur K. Shapiro and Elaine Shapiro, The Powerful Placebo: From Ancient Priest to Modern Physician (Baltimore: Johns Hopkins University Press, 1997). and Anne Harrington (editor), The Placebo Effect: An Interdisciplinary Exploration (Cambridge, Mass.: Harvard University Press, 1997).
Order The Powerful Placebo.
Order The Placebo Effect

Chapter 3 -- Clinical Trial Ethics
In this chapter I examine the checkered history of clinical trials, and I discuss the development of the ethical codes that are currently in force. Using examples, I describe the ethical responsibilities of investigators and of patients. Finally, I discuss what to do and how to complain if you encounter an ethical problem--or any other kind of problem--while participating in a clinical trial.

The federal regulations setting out all the rules for the conduct of clinical trials were revised most recently in 1991. They are part of the Code of Federal Regulations, Title 45, which deals with public welfare. The relevant section is Part 46, "Protection of Human Subjects." Here's a link to the full text of 45CFR46.

The Office for Protection from Research Risks (OPRR) is responsible for administering these regulations. OPRR is part of the the National Institutes of Health (NIH), which itself is part of the U.S. Department of Health and Human Services. OPRR has jurisdiction over all clinical trials in the U.S., even those that are not sponsored by the NIH and its member institutes.

Many of the current ethical considerations regarding clinical trials grew out of the Nuremberg Trials at the close of World War II. These war-crimes trials revealed to the world the atrocities committed by the Nazis in the name of science. The best book on this subject is:
Robert Jay Lifton, The Nazi Doctors: Medical Killing and the Psychology of Genocide (New York: Basic Books, 1986), 561 pp.
Order The Nazi Doctors

Despite the Nuremberg Code promulgated at those trials, research abuses continued, even in the United States. One of the worst examples was the shameful Tuskegee experiment, in which 400 African-American men with syphilis were left untreated for decades--even after a cure for syphilis became available--so that scientists could study the natural course of the disease. An excellent book on this subject is:
James H. Jones, Bad Blood: The Tuskegee Syphilis Experiment (New York: Free Press, 1993).
Order Bad Blood. (Unfortunately this book is out of print, but Amazon.com may be able to find it for you. It is also available in many libraries.)

An excellent book that takes a scholarly look at the ethics of clinical trials is:
Harold Y. Vanderpool (editor), The Ethics of Research Involving Human Subjects: Facing the 21st Century (Frederick, Maryland: University Publishing Group, Inc. 1996), 531 pp.
Order The Ethics of Research Involving Human Subjects

Arthur Caplan is one of the best known and most outspoken bioethicists. Several chapters in the following book relate to human experimentation:
Arthur L. Caplan, If I Were a Rich Man Could I Buy a Pancreas? and Other Essays on the Ethics of Health Care (Bloomington, Indiana University Press, 1992), 85-99.
Order If I Were a Rich Man in hardcover or paperback.

Chapter 4 -- How To Find Clinical Trials
There are many ways to find clinical trials, including asking your doctor, calling the National Cancer Institute, searching various Internet sites, perusing the news media, and hiring research services. Unfortunately none of these methods is completely comprehensive. For that reason, you may wish to use several techniques simultaneously, and you may want to repeat your searches once a week or so, since new clinical trials are being announced all the time. This chapter discusses many different ways to find clinical trials.

The first step is to understand your medical condition, and you may wish to arm yourself with a good medical dictionary. Here are three of the best. (I prefer Taber's.) Clayton L. Thomas, (Editor), Taber's Cyclopedic Medical Dictionary, (Philadelphia: F.A. Davis Co. 1997), 2,439 pp.
Thomas Lathrop Stedman, Stedman's Medical Dictionary (Williams & Wilkins, 1995), 500 pp.
W. A. Newman Dorland (Editor), Dorland's Illustrated Medical Dictionary, (W B Saunders Co., 1994), 1,974 pp.
All three of these dictionaries are updated every few years, and you should always try to obtain the most recent edition. Order Taber's.
Order Stedman's
Order Dorland's

Here's another book (in addition to the aforementioned Informed Consent) that explains how to find out about treatments for cancer: Gary Schine with Ellen Berlinsky, Cancer Cure: How To Find And Get The Best There Is (formerly titled If the President Had Cancer . . .) (New York, Kensington Books, 1994), 183 pp.
Order Cancer Cure

The premier web page for finding clinical trials is certainly the NCI's PDQ (Physician's Data Query) site.

Another good site is the CenterWatch Clinical Trials Listing Service^tm, which contains a searchable database of 7,500 current clinical trials in all areas of medicine, including cancer.

Chapter 5 -- Special Types of Trials
In this chapter I discuss trials of preventive and adjuvant therapies, trials of supportive therapies, and trials for new surgical techniques and new medical devices. I conclude with a discussion of genetic trials, which may not help individual participants, but which may ultimately lead to a true understanding-- and, we hope, a true cure--for cancer.

Chapter 6 -- Choosing Possible Trials
In this chapter I discuss a few general considerations for narrowing your choice of trials, and then I look at unique considerations involved in clinical trials for children and for people with advanced cancer.

Another book in the Patient-Centered Guide series specifically discusses childhood leukemia: Nancy Keene, Childhood Leukemia: A Guide for Families, Friends, & Caregivers, (Sebastopol: O'Reilly & Associates, 1997), 539 pp.
Order Childhood Leukemia

Chapter 7 -- Evaluating a Clinical Trial
Let's say that you've found one or more candidate clinical trials for your cancer after using the techniques suggested in previous chapters. How do you decide which if any of these trials are for you? If you meet the inclusion criteria and the exclusion criteria don't disqualify you, take a very close look at the informed consent document and--if you can get your hands on it--the trial's protocol. Then you should make sure you get answers to all your questions for the investigators and the clinical trial staff. Finally, there are a number of questions you should ask yourself before deciding to proceed.

Chapter 8 -- The Administration of Clinical Trials
"You can't tell the players without a scorecard," shouts the ballpark vendor. If you're considering a clinical trial, it's important to understand who the players are, and what positions they play in the complex--and deadly serious--game of cancer research.

Chapter 9 -- Financial Issues
In this chapter I discuss some important monetary issues surrounding clinical trials. First, I give you some background on the rapidly increasing costs of drug development, of which clinical trials are a significant part. Then I examine how these high costs (and disagreements about who will pay for them) can affect you. It can be difficult--but it is certainly not impossible--to get your insurance company to pay for the routine medical costs involved in clinical trials. And if your insurance company won't pay, I take a look at some of the alternatives you have for funding your medical care. Finally, I list some agencies that can help you with the expenses associated with traveling to distant clinical trials.

There's an excellent chapter on traveling for care in:
Lorraine Johnston, Non-Hodgkin's Lymphomas: Making Sense of Diagnosis, Treatment, and Options (Sebastopol, CA: O'Reilly and Associates, 1999), 556 pp.
Order Non-Hodgkin's Lymphomas

Appendix A -- Resources

Appendix B -- Critical Public Documents

Jeffrey P. Kahn, Anna C. Mastroianni, and Jeremy Sugarman (editors), Beyond Consent: Seeking Justice in Research, (New York, Oxford University Press, 1998), 190 pp.
Order Beyond Consent

Nancy Keene and Ragel Prentice, Your Child in the Hospital: A Practical Guide for Parents (Sebastopol: O'Reilly & Associates, 1999), 160 pp.
Order Your Child in the Hospital

Nancy Keene, Working With Your Doctor: Getting the Healtcare You Deserve, (Sebastopol: O'Reilly & Associates, 1998), 357 pp.
Order Working With Your Doctor

Musa Mayer, Advanced Breast Cancer: A Guide to Living With Metastatic Disease, (Sebastopol: O'Reilly & Associates, 1998), 540 pp.
Order Advanced Breast Cancer