Realizing the Promise of Clinical Trials in Cancer Care.

02/01/2016 19:32

Education & Research Clinical trials determine safe, effective treatments and combinations to better treat cancer, and provide participating patients access to new experimental therapies.

  Realizing the Promise of Clinical Trials in Cancer Care                                                                     
LoRusso is a fierce advocate for improving outcomes through clinical trials. "Cancer clinical trials measure whether new therapies are better than the best treatments we have today," she urges.

If you have recently been diagnosed with cancer, or you've been living with cancer for some time, you're probably dealing with fear and uncertainty. Regardless of the treatment you're receiving, you may be hoping to find a better one, to take advantage of the big strides that doctors and scientists are making against this disease. To do that, you may want to consider participating in a clinical trial.

In simple terms:

What is a clinical trial? Basically it is a carefully controlled and monitored research study in which treatments that are being developed are given to people to see if they are safe and effective against their disease. Cancer clinical trials measure whether new therapies or new combinations are better than the best treatments we have today, which we call standard of care.

Through a clinical trial, you may have access to experimental treatments that could be more effective against your disease than the treatment you are receiving now. In many cancer clinical trials, the focus is on patients for whom standard of care didn't work, or has stopped working, and the experimental treatment may offer another chance to slow or stop the disease.

The process:

Before new treatments are given to people, they are carefully evaluated in the laboratory and in animal studies. With the backing of good research results, the treatment moves into Phase 1 and 2 studies with small numbers of patients starting at the lowest amount of new drug to make sure the new treatment is safe, to determine the best doses to use, and to measure the impact on the disease.

"Less than 5 percent of cancer patients in the United States sign up to participate in clinical trials and many proposed trials fail to launch because of the lack of patient participation."

When we know that the treatment is safe and that there is some positive effect on the disease, the treatment goes into larger Phase 3 trials with more patients. The purpose of those studies is to see if the new drug or treatment works better than the standard of care.

For example, a large national clinical trial in a certain type of metastatic melanoma offers a new treatment approach to people for whom standard treatments, including the newest immunotherapy treatments, haven't worked. Led by the SU2C-MRA Melanoma Dream Team, the trial uses genetic sequencing to match patients to specific drugs based on their own tumor's biological make up, an approach called "precision medicine." This trial will help determine if this type of precision medicine might be a better way to treat this terrible disease.

Assigning care:

Depending on the type of trial, people who enroll are usually randomly assigned to receive either the standard of care only, or the standard of care plus the treatment being tested. That way, you as the patient aren't missing out on anything-you get at least the treatment you would be receiving anyway. This is true particularly in large Phase 3 trials.

Sometimes the new treatment simply doesn't show any better effect than the standard of care. Or it might show only a slightly better effect. And sometimes the side effects of the new treatment outweigh its positive impact on the disease.

But sometimes the new treatment is very effective, causing tumors to shrink or disappear. The impact can last for months and sometimes years. If the positive impact is significant enough, the company developing the drug or therapy can request review by the U.S. Food and Drug Administration so it can be approved and get into doctors' offices.

Lack of volunteers:

Unfortunately, less than 5 percent of cancer patients in the United States sign up to participate in clinical trials and many proposed trials fail to launch because of the lack of patient participation. Yet none of the successful drugs we have today would be available without people enrolling in clinical trials.

If you are interested in looking into a clinical trial, a free clinical trial finder service can identify clinical trials that might be relevant for your-or your loved one's-cancer. Please discuss it with your doctor at your next visit. Even if a clinical trial that may apply to you is being conducted at a major medical center outside of your area, you may be able to participate.