Inclusion of Older Patients in Cancer Clinical Trials

Everything that is known about treating cancer, or other serious illnesses, is due to clinical trials. Clinical trials, which are delivered in three phases, test a new drug or device or strategy to determine whether it is effective in the treatment of X disease. When our doctors talk about the importance of evidence-based medicine, they are talking about the results of trials.

Since the incidence of cancer increases with age, it is very important to understand whether a particular treatment is equally effective and safe for someone in their 70s as for someone who is decades younger.

Cancer clinical trials are the final step in a usually long research program that begins in the lab. Often scientists have been working for years to understand the possible value of a new drug before any humans are exposed to it.

The goals of cancer clinical trials include finding better ways to prevent cancer, to detect and diagnose cancer, to treat cancer, and/or to manage symptoms. There are many types of trials, and a good place to learn more is the National Cancer Institute's website.

Clinical trials are designed in many different ways, but the most advanced ones are called randomized clinical trials. In these, two different treatments are compared to one another. Often one is a standard and known treatment and the other is the new drug being tested. It is critical to learn if the new one is less good, equally good, or even better than the older one and how the experience (meaning side effects) is for patients. The hope is always that the new drug will result in a better quality of life and a longer life.

One long-standing concern has been that older patients, usually defined as people 65 and older, have not traditionally participated in clinical trials. Whether this is because they have not been recruited, perhaps because they went for treatment to smaller centers that didn't offer trials, or because there have worries about their reactions, the result has been diminished involvement. All trials have very specific inclusion criteria, and these have often excluded older people. Since the incidence of cancer increases with age, it is very important to understand whether a particular treatment is equally effective and safe for someone in their 70s as for someone who is decades younger.

Fortunately, this is changing. Doctors now believe there is no reason why older people should not be involved in trials and every reason that they should be. Studies have shown that older people are as interested in participating as younger ones and just need to understand the opportunity. How do you find out if there is a clinical trial that is appropriate for you? The easiest answer is: Talk with your doctor. Often the best treatment choice is the standard of care, but there are times when a trial may be a wise option.

An important sobering reminder is that many clinical trials find that a new drug is not as helpful as the existing treatments. Participating in a clinical trial is not a guarantee that you will have access to the newest miracle cure. Sometimes, think Herceptin or Gleevac, a new cancer medication is a real game-changer. More often, a new drug may help extend life or the time until disease progression.

You can also do some research on your own. Check out the following resources:

• Finding a Clinical Trial (Cancer.Net)
• ClinicalTrials.gov

BIDMC also has an active program of cancer clinical trials, often working with colleagues from the Dana Farber Harvard Cancer Center.