Clinical Trials

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What are Trials? • How are Trials Conducted?
Participating in a Trial • Is a Trial Right for Me?

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What are Trials?
Scientists are constantly searching for better ways of dealing with breast cancer. Many women diagnosed with breast cancer may benefit from this research by participating in clinical trials.

A clinical trial is an evaluation of a new way of managing cancer. Some trials are designed to see if a new drug or a new procedure will be effective in treating or preventing cancer. Other trials evaluate new ways to diagnose the disease. Still others concentrate on finding a new way to eliminate unwanted side effects.

Clinical trials help improve the quality of care, now and in the future. One such trial, conducted many years ago, showed that lumpectomy with radiation treatment was as effective as removal of the entire breast, which was the standard practice back then. As a result of this trial, many women today can enjoy the benefits of breast-conserving surgery.

Clinical trials are not random attempts to discover something new. Trials are conducted according to very specific guidelines that are recognized by the medical community worldwide. By ensuring uniformity, it is possible to be confident that results obtained in one location, will be readily comparable to results from another location, even in another country.

New treatments are first tested in laboratories, using animals. Animal research offers scientists the only way to make the transition from something that works in a test tube to something that will work in people, without risking human lives unnecessarily in the process.

If there is initial evidence that the treatment may be effective, it is then evaluated further with actual patients, usually with advanced stages of the disease.

To reach the next trial stage, where large numbers of patients are used, the treatment method or drug must have demonstrated that it offers potential benefit, without unacceptable risk.

If the clinical trial confirms the benefits, the drug or treatment will be made available to all patients.

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How are Trials Conducted?
Every trial is conducted according to a protocol—a set of guidelines that spells out exactly what will be done and when. Large numbers of patients are selected according to very specific criteria—age, stage of cancer, previous treatment, and so forth.

The patients who meet these criteria are enrolled into the study, and divided into groups. Most trials consist of a control group (patients who are receiving standard therapy) and a treatment group (those who receive the new therapy that is being evaluated.) The treatment group always receives treatment that is considered to be at least as good, and possibly better, than the standard treatment. Sometimes the control group receives a placebo—an injection or a pill that looks like the drug being evaluated, but has no medicinal value; for example, a sugar pill instead of a drug.

Patients are assigned to one of the two groups by a random, computerized system, where neither the patient nor the physician has control over the selection. In addition, neither the patient nor the investigator knows which group the patient was placed in, until the end of the trial. This process is called double-blind randomization. The purpose is to avoid bias on the part of the patient or the treating physician. In other words, random assignment keeps the researcher from favoring one or the other group, and skewing the results. Not knowing whether the actual drug or a placebo is being administered, eliminates pre-conceived notions, and keeps the patient from reporting improvement or side effects that may be imaginary.

A central agency keeps all the records of the selection, and can reveal them if the need arises. Sometimes, if one group is showing a significantly better response than the other, the trial is terminated, and all patients are given the better treatment.

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Participating in a Trial
If your physician does not mention trials, you may want to bring up the subject on your own. There are many trials going on around the country, and you may just find one that matches your case perfectly.

Generally, you or your physician can obtain information about ongoing trials from the National Cancer Institute's hotline called PDQ, or from the local chapter of the American Cancer Society.

You and your physician will review the lists of requirements for various trials to see whether or not you might qualify for one of them. If you do, be sure to find out what is involved in terms of tests, treatments, additional time commitments, and side effects, and evaluate whether or not you can live with these terms for an extended time. Then assess the possible benefits to you, and balance them against the negatives.

If you decide to proceed, you will be asked to sign an informed consent form, to show that you understand the issues involved, the expected benefits, the possible side effects, your rights and responsibilities, and the possible outcome.

You will be asked to follow the schedule of treatments and tests as closely as possible, in order to make the information obtained scientifically sound.

 

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Is a Trial Right for Me?
Trials are what makes it possible for medicine to make progress. But you won't be participating purely for the good of others. Being part of a trial offers a definite benefit for you personally, whether you are assigned to the treatment group and receive the new drug, or you wind up in the control group and receive conventional therapy.

One of the advantages of being in a clinical trial is that patients in both treatment and control groups enjoy a higher standard of care, because trial protocols usually call for more frequent tests, more frequent visits to the hospital, and more thorough examinations.

And there are few, if any, downsides. Your participation is completely optional and voluntary. You can leave the trial at any time. If you drop out, you will not be penalized in any way, and you will still be entitled to the best standard treatment available.

 

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