ADVICE FOR PROFESSIONALS

A clinical trial is a research study designed to evaluate a new cancer treatment. Patients enrolled in a clinical trial are among the first to receive new treatments before they are widely available. In most cases, patients are randomly assigned to either a conventional or experimental treatment group. In the former, patients are offered the best current therapy. In the experimental treatment arm, patients receive new drugs, dosages, combinations, procedures or routes of administration. Ultimately, there is the possibility of a better medical outcome in the experimental group.

Clinical trials continue to play a key role in the progress against cancer. Yet only 3% of all cancer patients are entered into clinical trials. This Professional Brief is designed to help you speak to your patients about clinical trials.

Rationale

In general, the public lacks information about the overall value of medical research and clinical trials as a treatment option. In some instances, there may be outright suspicion about experimental research and fear of being a "guinea pig" for unsafe drugs or practices.

For these reasons, patients and families need information about clinical trials to ease their decision-making. A balanced approach is best, one that covers both the benefits and drawbacks of clinical trials. In our experience, patients appreciate clear-cut responses to their questions, and usually need help in formulating new questions that have not occurred to them.

This Brief is divided into three sections that discuss the medical, practical and emotional considerations in clinical trials. The last section covers the major advantages and disadvantages of participating in a clinical trial.

I. Medical Considerations

In a clinical trial, the first thing a patient needs to understand is the specific treatment being offered and how it differs from the standard treatment available for his or her cancer. An explanation of the the eligibility criteria for the trial is also important, so that patients do not misinterpret their inclusion into (I will be cured) or exclusion from (I must be dying) the trial.

Next, if there are potential side effects of the new treatment, patients should be told about these ahead of time. They should understand the likely physical limitations that may result from the new treatment, and how these will impact upon their quality of life. Steps for pain relief should also be addressed ahead of time. Those details are outlined in each clinical trials' "informed consent" statement, which is required by law. However, patients can generally benefit from more in-depth discussion.

II. Practical Considerations

Cancer Care's experience has shown that patients are concerned about many practical issues when trying to decide whether to join a clinical trial. Discussing these issues ahead of time can do much to allay anxiety and help patients and families prepare for a trial.

First, patients should know whether a clinical trial is available for their type and stage of cancer. This information is accessible through the patient's physician, or the Cancer Information Service, which will print and mail the patient a copy of the Physicians Data Query (or PDQ) for any trial, free of charge. Patients will also want to know whether participation in the trial will involve traveling to another medical facility, city or state. They will need to understand the expected duration of the treatment and what time commitment they will be required to give.

Second, patients need to know the costs involved, given that most health plans exclude coverage for experimental treatment, including associated physician and hospital expenses. Often, the cost of the new drugs used in the trial will be covered by the project sponsor. However, patients participating in a clinical trial may need to advocate for reimbursement from their insurers. This can be stressful and time-consuming, with no guarantee of a decision in their favor. In addition, patients will have to consider the out-of-pocket costs of travel, hotels, meals, and parking. (In this case, people can usually benefit from local maps, telephone numbers and resources.)

Third, most patients want to know whether their family members can accompany them to treatment. In general, it is advisable to include family caregivers in both decision-making and helping the patient take part in the clinical trial. Written education materials about the clinical trial, including the PDQ, are enormously helpful.

III. Emotional Considerations

First and foremost, patients may be concerned about becoming "guinea pigs" in an experimental research study. They need to be reassured that safeguards are built in to all clinical trials to protect participants' medical and psychological health. In addition, all trials are subject to peer review by the institution, the study sponsor and the scientific community. Ultimately, the right to refuse or terminate participation at any time in clinical trials is guaranteed.

If entry into the trial means changing physicians, or dealing with more health care professionals, patients need to prepare for this shift. Patients should also consider the impact of their involvement on their loved ones, as well as their work situation.

Lastly, patients will always be concerned about the likelihood of the new treatment succeeding. "Will it work?" is a weighty question, worthy of consideration. If conventional treatment has not worked, the decision to enter a clinical trial may give rise to solemn concerns such as: "If I choose experimental treatment, does this mean I'm dying?"

Conclusion

In order to help patients decide whether to participate in a clinical trial, it is best to present a balanced view of the benefits and drawbacks of their participation. Ultimately, it is the patient's own decision.

The advantages of a clinical trial for a cancer patient are many. There is a chance that the new treatment will work and improve the patient's health and prognosis. Patients will receive extensive monitoring, close follow-up during the trial and perhaps better medical and psychosocial care than patients on conventional treatment.

On the other hand, there are possible disadvantages to clinical trials. Patients may feel like research subjects rather than individuals, and they may have to invest more time than in conventional protocols. Another possible drawback is in the area of insurance reimbursement, where patients may encounter problems with exclusions and denial of coverage.