The Importance Of Clinical Trials

How important are clinical trials to cancer patients? Why should patients participate in these trials?

Dr. Balch: First, cancer clinical trials provide the very best standard of care. They provide a consistent and structured method of delivering a standardized care as prescribed in the trial’s protocol so that all patients in a clinical trial wherever they are — such as a small hospital in a rural area or a large hospital in a metropolitan area — are treated in exactly the same way.

Second, they allow us to validate the potential benefit of new therapies as they become available, such as improved survival rates or reduced complications or side effects. Clinical trials can also identify characteristics of patients who might be at increased risk of complications or those who might have maximum treatment benefit. Just as important, they may reveal groups of patients who don’t derive a benefit from an experimental treatment.

The protocol-specific therapy may help the patient and the clinical trial will determine if this occurs. If it does occur, the patient will continue. If not, the patient will be offered alternatives. I tell my patients that the standard of cancer care we provide today is the result of clinical trials that were completed in the past by patients who volunteered to participate in a clinical trial, and in so doing, invested in the future of  cancer care. Thus, when cancer patients participate in clinical trials, we can validate and refine the indications, risks, and benefits of new therapies. As a consequence, a clinical trial can not only help patients in the present but also help future patients, including their own family and friends who may develop cancer later on.

A good example is the remarkable treatment advances we’ve had in breast cancer therapy, most of which are built on clinical trials. Advances in cancer therapy validated by clinical trials have revolutionized the way we treat breast cancer patients today, compared to our treatments 10 or 20 years ago.

You’ve mentioned some of the benefits of participating in clinical trials. What are some of the risks?

Dr. Balch: Clinical trials inherently carry the risk of the unknown, such as side effects and whether the new treatment or new combination of treatments will really improve survival rates. Thus, there is a risk of the unknown as to how these new treatments or diagnostics may or may not benefit our patients or have unanticipated toxicities. That’s why patients have to be informed and sign an agreement that they understand the potential benefits and potential risks.

What can you say to a patient who recognizes the benefits of a clinical trial but is afraid of the risks?

Dr. Balch: The first thing I tell my patients is that a clinical trial is intended to improve on the standard of cancer care, but since it is a clinical trial, there is no bias if they choose not to volunteer for their own reasons. I also tell them that if they agree to go into a clinical trial and if it doesn’t meet their expectations, they can decide to withdraw from the trial and return to standard treatment.

Our patients should take comfort in knowing that there are very elaborate safeguards established by institutional review boards to monitor patient safety and make sure all of the known risks and benefits are explained in language patients can understand. We are constantly monitoring the safety of patients.

Should cancer patients try to find clinical trials on their own or it is best to work through their doctor?

Dr. Balch: My hope is that readers of the Patient Resource Cancer Guide will recognize the value of clinical trials and seek out physicians who include clinical trials in their practice. Patients can also go to various Web sites listed in the guide to see what clinical trials are available for their stage of disease. Finally, patients should ask their doctors whether they will have access to clinical trials

What kinds of clinical trials are available to cancer patients?

Dr. Balch: There are thousands of clinical trials available throughout the country. Part of the problem for patients and even for us physicians is knowing all of the trials that might be available. A lot of networking and communication goes on among physicians.

An increasing number of Web sites are available where both physicians and patients can go to find out about clinical trials. One example of these Web sites is clinicaltrials.gov.

What additional advice do you have for cancer patients in regard to participating in clinical trials?

Dr. Balch: I encourage all cancer patients to consider participating in clinical trials that are appropriate for their stage of disease. Their participation might be as simple as allowing information about their cancer treatment or their pathology specimens to be used for research. That involves no risk on their part. Or their participation might involve volunteering for clinical trials designed to improve their treatment or combinations of treatment that may benefit them directly as well as future generations of patients.