Clinical Trials


Bob Riter
Bob Riter

People diagnosed with cancer often wonder if they should participate in a clinical trial.

When someone asks for my opinion, I begin by saying that clinical trials are essential for the advancement of medicine. For example, one clinical trial found that women with early-stage breast cancer did just as well after a lumpectomy (followed by radiation), than did women who had a mastectomy. This finding greatly reduced the number of mastectomies that were being performed in this country and elsewhere.

That said, a clinical trial may or may not make the most sense for a specific individual at a specific point in time.

It’s helpful to have a general understanding of the different types of clinical trials.

A Phase 1 trial is a very small study to find out if a new treatment is safe. They aren’t testing the effectiveness of the treatment against a particular disease, just its safety in humans.

A Phase 2 trial is slightly larger and is used to determine if the new treatment seems to be effective in treating the disease under investigation.

If the Phase 2 trial is successful, a Phase 3 trial may be undertaken to determine how the new treatment compares to existing treatments. Is it better, worse, or the same? These trials are much larger than Phase 1 or 2 trials, and patients are often recruited at multiple locations, including community hospitals. (Phase 1 and 2 trials usually take place only in major research institutions). The results of Phase 3 trials often change the standard of care.

Thus, clinical trials are good and are to be encouraged. Participating in a trial can also connect patients with clinicians and researchers who are experts in their particular type of cancer.

But it is important to remember that the “new” treatment does not always prove to be better than the standard treatment.

My advice for people considering a clinical trial is to talk with their oncologists as to which trials are available and the potential pros and cons of participating.

Here are some key points to consider:

  • How effective is the standard treatment likely to be in your situation? In some cases, the standard treatment is highly effective and easily tolerated. In other cases, the standard treatment doesn’t offer much hope. Knowing this information helps guide your decision-making.
  • Is it a Stage 1, Stage 2 or Stage 3 trial? Stage 1 trials are riskier than Stage 2 trials which are riskier than Stage 3 trials, but taking risks sometimes makes sense.
  • If considering a trial, I’d ask the physician to compare the experimental treatment with the standard treatment. What are the potential benefits and what are the potential side-effects for each? Making this head-to-head comparison provides useful context.
  • How convenient will it be for you to participate in the trial? While some trials are available locally, others require regular trips out of town. Some allow you to have blood tests and imaging (e.g., CT scans) performed locally. Others require that all tests be performed in the research hospital. Find out what’s required by the trial that you’re considering.

In sum, clinical trials are important, necessary, and worthwhile. Participating in a trial is altruistic because others with your disease will benefit. The benefit to you as an individual, however, depends on your specific situation. It’s a good conversation to have with your oncologist.

Published with permission of the Ithaca Journal.
Original publication date: June 30, 2012

Excerpted with permission from When Your Life is Touched By Cancer: Practical Advice and Insights for Patients, Professionals, and Those Who Care by Bob Riter, copyright (c) 2013, Hunter House Inc., Publishers.