One of the options for treatment your oncologist may recommend is for you to participate in a clinical trial. Clinical trials are carefully designed research studies that answer specific questions regarding the effectiveness and safety of new drugs, combinations of drugs, treatments, surgical techniques, or medical devices.

Human volunteers with specific health conditions are studied during the trials to determine the efficacy of the new approaches. You may want to consider participating in a clinical trial as these trials offer access to promising new treatment options before they are approved by the FDA and are made generally available.

Phase III clinical trials are conducted in “controlled” conditions, meaning that one group of participants receives the therapy being tested and another does not. Later, health information from the two groups is compared to determine if the new therapy had any effect. All of these trials involve the process of “randomization,” in which groups of patients are randomly chosen to receive one treatment or another (placebo), thus reducing the chance of bias in the findings.

Many of these controlled trials do allow those volunteers who received a placebo to receive the trial treatment after their participation has been completed.

Clinical trials are conducted by individual institutions (called investigator-initiated trials) or in cooperation with several institutions (called multi-institutional trials). They are organized in cooperation with pharmaceutical companies and with government research organizations such as the National Cancer Institute.

Should You Participate?

Clinical trials have been largely responsible for most of the important advances in the treatment of cancer in recent years. The key to their success is finding suitable human volunteers to participate. By participating, you can obtain access to innovative treatments while helping advance researchers’ understanding of cancer. Without volunteers in the trials we will not be able to advance our knowledge about fighting cancer.

Clinical trials are at all times highly regulated and monitored by the Food and Drug Administration. Trials cannot begin until rigorous intensive reviews have taken place. These revues are designed to insure the scientific rationale behind the trial is valid and that there is a fair balance of patient risk and benefit. Still, despite the careful regulation of clinical trials, you should be aware that there are potential drawbacks and risks in addition to the potential benefits of clinical trial participation.

The National Cancer Institute lists the following possible benefits and drawbacks for individuals considering clinical trials.

Potential benefits:
You will receive high-quality health care provided by leading doctors in the field of cancer research.
You will have access to new drugs and interventions before they are widely available.
Your health care will be closely monitored, along with any side effects related to the treatment.
You will play a more active role in your own health care.
If the approach being studied is found to be helpful, you may be among the first to benefit.
The trial will provide an opportunity for you to make a valuable contribution to cancer research.

Potential risks:
New drugs and procedures may have side effects or risks unknown to the doctors.
New drugs and procedures may be ineffective or may be less effective than current approaches.
Even if a new approach has benefits, it may not work for you.
Some health insurance plans prohibit or restrict coverage for clinical trials. Refer to the section titled “Health Insurance” in the chapter “Living With Cancer Day to Day.”

The fact that you have cancer doesn’t make you automatically eligible for a specific clinical trial. You will have to fit certain requirements of the trial eligibility criteria.

Selecting a Clinical Trial
It is important for you to understand what a clinical trial is, why it is being done, and how you can gather more information regarding the trial you are interested in. Discuss the trial in detail with your oncologist and nurse and be sure to ask any questions you have regarding treatment, potential risks and your possible participation.

At any time, there may be many clinical trials. You or your doctor can get a list of current clinical trials by looking at descriptions of clinical trials at the National Cancer Institute website,

Before you make any decision, you may want to read “Taking Part in Clinical Trials: What Cancer Patients Need to Know” (NIH Publication 97-4250). This pamphlet can be obtained online or from the Cancer Information Service at 1-800-4-CANCER.

Once you have been given information on treatment options including participation in a clinical trial, review the information carefully. You should feel free to contact the study’s doctor (Principal Investigator) and their nurse (Research Nurse) with any questions you have regarding the treatment options, possible side effects, and frequency of clinic visits involved in the trial. Rely on your own doctor to translate the information so that you can make an informed decision regarding your treatment.

Joel T Nowak MA, MSW