Although the past decade has been marked by the most encouraging improvement of the century in the success rate for cancer treatment, there are still too many cancer patients who are succumbing to their disease. We have learned that the most significant progress in cancer management comes from evidence supplied by well-designed and well-executed clinical trials in an age of "evidence based medicine."

What benefit can a patient expect from a clinical trial? Clearly, in a Phase I clinical trial which is designed to explore the toxicity of a new treatment, the patient who volunteers for these studies cannot expect to derive a benefit although it is conceivable that this can occur. Most participants in Phase I trials understand that the information which will be derived can be of potential benefit to future cancer patients.

Phase II clinical trials are designed to establish the efficacy of a treatment program for specific cancer sites. Patients who enter Phase II trials can have a reasonable expectation that the new, experimental treatment may be of benefit for their specific kind of cancer. It is the purpose of a Phase II trial to determine the percentage of patients that can expect a response and how durable that response will be.

In Phase III clinical trials, patients may be randomized to receive a new treatment program which has shown significant responses in Phase II studies. Some patients will receive the standard best known treatment available today (the accepted community standard of care) and others will receive the promising new treatment. Thus, patients can expect to receive the best clinical care available or a new experimental treatment which has shown the potential of improving the likelihood of success.

Before a patient signs onto any of the clinical trials, the patient should carefully explore with their oncologist, primary care physician, and other sources of information available on the Internet as to the benefits that the patient can expect from participating in this clinical trial as well as the known toxicity of the experimental treatment as compared to the known toxicities of established treatments. They need to ask if they fail to respond to one arm of the study, can they expect to be crossed over to the other arm? If not, what future course of treatment can the patient expect to receive? If the patient were to develop a serious complication of treatment, can s/he expect to be given the best corrective care available in or out of the hospital and will this be provided without a financial risk to the patient and his/her family?

Before volunteering for a clinical trial, the patient may wish to ask the physician in charge of the trial about the extent and experience of the team of doctors, nurses, et al performing the clinical trial. In addition, the patient should know that the investigative program has been reviewed by an Institutional Review Board which has scrutinized the study carefully and has approved the investigation and the physicians who are participating in the trial. It is also worthwhile for a patient to determine if the physicians and/or the institution have any conflict of interest which may influence their judgment in the performance and/or the evaluation of the study being offered.

Only a well informed patient can give an informed consent. The more that the patient knows about the disease and the treatment options available, the risks and alternatives, only then can they knowledgeably agree to participate in a clinical trial. It is the responsibility of the team performing these studies to make available as much information available as is necessary to be completely informed. Furthermore, more important than any six or eight page "informed consent" is the social contract between the treating physicians and the patient, and this can only be based on mutual trust and understanding.

For more information and answers to specific questions contact the Rhode Island Cancer Council at maureen@ricancercouncil.org or call us at (401) 728-4800 or toll free 866-879-4100.

IT IS EASIER TO PREVENT CANCER THAN TO TREAT IT.

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