Clinical trials are the backbone of progress in cancer research. Yet the National Cancer Institute estimates that fewer than five percent of cancer patients participate in clinical trials, despite often heroic efforts on the part of researchers to recruit participants.

"Increasing participation in cancer clinical trials is a major goal of the NCI and other cancer organizations," said Linda Lamb, editor of Robert Finn's new book, Cancer Clinical Trials: Experimental Treatments and How They Can Help You.

The NCI knows that a significant increase in participation would enormously speed up the development of effective therapies and better use of existing ones. A recent breakthrough in breast cancer therapy using the drug herceptin was made possible by clinical trials, and the success of other trials has depended in part on a grassroots effort that recruited large numbers of participants for the trials.

Why then, is it so often hard to get patients into clinical trials?

One reason is a misunderstanding about the nature of clinical trials. Few patients want to be "guinea pigs" for some unproven therapy, and doctors are often hesitant to recommend clinical trials.

Cancer Clinical Trials teaches readers how to find and evaluate clinical trials and how to decide whether to participate in them. Readers learn the difference between Phase I, II, and III trials and why placebos are almost never given in cancer clinical trials (in most trials, everyone gets real therapy). They're also guided through the process of choosing and evaluating a clinical trial. As a resource for finding appropriate clinical trials, funding them, and understanding the history and science behind modern clinical trials, this book is of use not only for cancer patients and their families, but for the members of their healthcare teams as well.

We began our interview with author Robert Finn by asking him how his book is different from other books on clinical trials.

Finn:

There are no other books specifically about cancer clinical trials. The National Cancer Institute puts out an informative but fairly short brochure on clinical trials, and there are many other books about cancer that mention them. But this book goes into more detail than any other book out there on cancer clinical trials.

Also, the brochures and the other books that do mention clinical trials aren't always written from the patient's point of view. Sometimes they reflect the drug company's or the researcher's point of view. Like all of the books in the Patient-Centered Guide series, Cancer Clinical Trials is told from the patient's point of view or from a patient-advocacy perspective: what a person with cancer needs to know about clinical trials, how to find clinical trials, and how to decide whether a clinical trial is right for them.

One of the things that I think is especially valuable about the book is that it includes the voices of patients, people who have actually participated in clinical trials, with extended quotations from interviews I conducted with those people.

Allen:

How did you find these people?

Finn:

I found most of them on the Internet. There are a number of very good Internet sites on cancer and cancer clinical trials and an excellent email discussion group on cancer. I would find people through these areas who had participated in clinical trials and ask them if they would be interested in being interviewed. Virtually everyone said yes.

Allen:

So, the Internet is a good source of information about clinical trials?

Finn:

Oh, yes. The Internet makes it easy to find clinical trials. And there is such a wealth of information and support on the Internet for people with cancer and people considering clinical trials.

Allen:

Do you see an audience for this book beyond that of cancer patients and family members?

Finn:

That is the primary audience of the book. I think that everybody with cancer--and 1.2 million people a year are diagnosed with cancer in the United States--should consider clinical trials, and this book is the best way for them to do that. I think it will also interest people who are interested in the process of how drugs come to be tested. But the primary audience, and it's a large one, is people with cancer and their families.

Allen:

One of the things that non-cancer patients might find useful about the book is its history of medical experimentation and the evolution of patients' rights in response to it.

Finn:

Yes. One of the chapters in the book has a fairly detailed history of clinical trials going back, literally, to the Bible. I found the mention of clinical trials in the Book of Daniel, (Daniel 1:11). Unfortunately, the history of clinical trials has been a very checkered one. There were the well-known Nazi atrocities where they experimented on unwilling, involuntary subjects in concentration camps, horrific experiments.

It wasn't, unfortunately, just the Nazis who did unethical things at clinical trials; there have been plenty of unethical clinical trials in this country as well, most notably the Tuskegee syphilis experiment in which several hundred African-American men with syphilis were left untreated for decades even after good treatments for syphilis became available, just so doctors could watch the natural course of the disease. It was a terrible story that only came to light in 1971. Books were written about it, and it was a huge national scandal that was directly responsible for far more stringent federal controls on clinical trials.

It's extremely unusual these days for bad things to happen in clinical trials. There are so many protections for patients and participants. But this chapter goes into detail about the history and ethical obligations of both the researchers and the participants in clinical trials.

Allen:

The other thing that was valuable to me was that this book really makes it clear why the scientific method is important, how the principles we've developed for testing medical procedures work, and why procedures need to be tested beyond "anecdotal evidence."

Finn:

Yes. Every time I go into a bookstore I look at the health section and, in many bookstores, the number of books on alternative medicine exceeds the number of books on modern medicine. We know so much more than our ancestors did about how the body works and how to treat many diseases that I think people should consider modern medicine before they consider alternative medicine.

But let me say a couple of things about that as it relates to cancer clinical trials. First of all, in Phase I and Phase II clinical trials, everybody gets the study medication. Nobody gets the placebo. In Phase III, it is true that people are randomized and some people get the study medication, but the people who don't get the study medication almost never get inactive medication. Cancer is such a serious illness, it would be unethical to leave somebody untreated. What they do in Phase III cancer clinical trials is compare the new treatment against the current best standard treatment, so nobody is going without treatment. Even if you participate in a Phase III cancer clinical trial, you're guaranteed to get at least the best available standard treatment, or you might get the study medication.

Many people really want the study medication. I understand that, but I think people need to understand that the reason clinical trials are conducted is that scientists don't know whether the study medication is better than the standard medication. That's why they have to compare them. It may be worse than the standard medication, so I don't think somebody should necessarily be disappointed if they don't get the study medication.

Allen:

So, patients in clinical trails will probably get excellent care.

Finn:

Absolutely. You'd probably be watched much more closely than you would if you weren't participating in a clinical trial. The top doctors in your area will be looking at you, and they'll be examining you more closely and more frequently.

Allen:

What would you consider the most important message in this book?

Finn:

The most important message is that everyone with cancer should at least consider clinical trials along with the standard treatment options that are open to them. I am not saying that everyone with cancer should participate in a clinical trial--that's a very individual decision. It depends on your risk tolerance and what clinical trials are available for your specific cancer at the specific time that you're looking. But unless you are considering clinical trials along with the standard treatment options your doctor is offering you, you're simply not considering all the treatment options that are available to you.

There are some very promising treatments coming down the pike for various kinds of cancer, and clinical trials give you the opportunity to get a possibly better treatment years before it is available to the general public.

Allen:

Another aspect of clinical trials is that they benefit future cancer patients, though this may be a hard sell for patients who are struggling for their own survival.

Finn:

I think it needs to be emphasized that altruism is a very good reason to participate in clinical trials. Many people who have terminal cancers participate in clinical trials for that reason. Even though they know that there may be no realistic hope that the clinical trial will help them personally, they can take comfort in knowing that the information that scientists get by studying them will help other people down the road.

Allen:

What about the cost of clinical trials to the patient? Many HMOs do not fund experimental treatments.

Finn:

Any study that's funded by either the National Cancer Institute or another federal agency, or a pharmaceutical company, will pay the full cost of the study medication or the study treatment, the experimental part of the treatment.

What they will not pay is the cost of the standard treatment of somebody's cancer. The problem comes with some HMOs and insurance companies refusing to pay even the standard cost of standard treatment when a person is enrolled in a clinical trial. Some states have laws that require HMOs and other health insurance organizations to pay the standard costs of treatment for somebody enrolled in a clinical trial, but so far that's only a minority of the states. The State of Virginia, for instance, recently passed such a law in recognition of the importance of clinical trials to cancer research.

You may have heard of the Patients' Bill of Rights, which is currently being debated in the U.S. Congress. The Democratic version of the bill would require that insurance companies pick up the cost of standard care for people enrolled in sanctioned clinical trials. The Republican version does not require that, and neither version has been passed yet; it's still subject to discussion. Studies have shown that clinical trials cost only slightly more, if at all, than standard treatment.

Allen:

Just in terms of dollars and cents, it seems any advance in treatment is going to save money down the road.

Finn:

Oh, yes. The treatments that are being developed are going to be better and less expensive in the long run and people are going to live who would otherwise have died.

Allen:

What do you bring to this book in terms of your background and interests?

Finn:

I'm a biologist by training. I started out intending to be a research neuroscientist. Midway through the graduate program at the Department of Psychobiology at the University of California, Irvine, I discovered I preferred writing about science to actually doing the experiments, so I have been pursuing a career as a science writer ever since.

I have always been fascinated by the process of clinical trials: how drugs get from laboratory to the pharmacist's shelf. This was a casual interest until about six or seven years ago when I did some freelance work writing technical materials for a clinical research organization. I got to see from the inside what a clinical research organization is--a company that conducts clinical trials under contracts from pharmaceutical companies--and I got fascinated by the whole process of clinical trials.

Allen:

Tell me about your next book.

Finn:

The next book is another in the Patient-Centered Guide series. Its tentative title is Organ Transplants: Making the Most of Your Gift of Life, and it's for people who have had or who may need an organ transplant. It goes into detail about how the waiting list works, the various medications that people with organ transplants have to take, the side effects of those medications, and the emotional and psychological consequences of organ transplants.

Allen:

And will the book cover research that is being done in the field?

Finn:

The final chapter in the organ transplant book is called "The Future of Transplantation." It's a very fast-moving field that's changing literally every day.

Allen:

I understand that you are giving workshops based on your research for Cancer Clinical Trials. Can you tell me about that?

Finn:

Yes. My workshop, which I'll give for any cancer group who wants to see it, will take people through what clinical trials are, what the various phases of clinical trials are, how to find clinical trials, and how to evaluate clinical trials. Basically the same thing that the book does.

Allen:

So how could people get in touch with you to arrange a workshop?

Finn:

If they have a group of, say, 20 or more people who are interested in having this workshop, they should email me at finn@nasw.org.