Clinical trials are research studies that look at how well a new treatment or medical procedure works. These studies help improve the overall standard of care. Clinical trials are started only after earlier studies, done with cells or animals, suggest that the new treatment or procedure will help people and also will be safe for people.
Clinical trials are an important step in discovering new treatments for breast cancer and other diseases as well as new ways to detect, diagnose, and reduce the risk of disease. Clinical trials show researchers what does and doesn’t work in people. Clinical trials also help researchers and doctors decide if the side effects of a new treatment are acceptable when weighed against the benefits offered by the new treatment.
A study has found that people who were newly diagnosed with cancer were less likely to participate in clinical trials if their annual household income was lower than $50,000.
The study was published online on Oct. 15, 2015 by JAMA Oncology. Read the abstract of “Patient Income Level and Cancer Clinical Trial Participation: A Prospective Survey Study.”
Other research has shown that only a small percentage of adults diagnosed with cancer participate in clinical trials. Minorities are also much less likely to participate in clinical trials than whites.
In this study, the researchers looked at information from clinical trial enrollment at eight cancer clinics across the United States. More than 1,260 adults who were newly diagnosed with breast, lung, or colorectal cancer were asked to participate in a clinical trial on a new type of chemotherapy before they had made treatment decisions.
Most of the people in the study were:
- younger than 65 (71%)
- women (84%)
- not African American (93%)
The researchers followed the people in the study to see if they did enroll in the clinical trial. The researchers wanted to know if the patients’ income was linked to whether people did or did not enroll in the trial.
After adjusting for age, sex, race, education level, travel distance, and stage of disease, the researchers found that people with an annual household income below $50,000 were 32% less likely to participate in the clinical trial than people with higher annual incomes:
- 17% of people with incomes at $50,000 or higher participated in the trial
- 12% of people with incomes lower than $50,000 participated in the trial
The researchers also found that people’s participation in clinical trials was less likely the lower their household income was:
- 13% of people with incomes between $20,000 and $49,999 participated in the trial
- 11% of people with incomes of less than $20,000 participated in the trial
"The identification of patient income level as an independent predictor of trial participation is important for multiple reasons,” said the researchers. “If income is associated with health status, then improving representativeness of lower-income patients in trials would improve the generalizability of study outcomes. Also, greater participation of lower-income patients would allow trials to be conducted more quickly, speeding the development of new treatments. Crucially, since clinical trial treatments represent the newest available treatments, access to this vital resource should be available to individuals of all income levels."
Researchers don't know what the results of clinical trials will be. (If they did, they wouldn't have to do the trials.) This uncertainty can make it hard to decide if you want to participate in clinical trial. In rare cases, clinical trial volunteers have been hurt by the treatment or procedure being tested. At the same time, hundreds of thousands of people have been helped and are alive because other people chose to participate in a trial that resulted in a new, more effective treatment. While clinical trials are important, the choice to participate in one is very personal and depends on your unique situation. As with any breast cancer treatment, you and your doctor need to weigh the benefits against the risks and decide what's best for you.
As you're considering your choices, it can be helpful to ask the doctors doing the trial the following questions:
- Why are you doing this trial?
- Why do you think this new treatment will be effective?
- What phase is this trial?
- Has this treatment been tested before?
- What were the results of any previous trials?
- Can I talk to someone who's already in the trial?
- Who is paying for the trial?
- What are the possible treatments I can get? How often are they given?
- What types of tests will I have to have and how often will I have to have them?
- How will being part of this study affect my daily routine?
- What side effects am I likely to have?
- Will my treatment be free? Will my insurance cover any of the cost? Exactly what will I have to pay for?
- How long will the trial last?
- Is long-term follow-up care part of the trial? What does it involve?
- If the treatment works for me, can I continue to get it after the trial is done?
- How do I get the results of the trial?
For more information, visit the Breastcancer.org Clinical Trials pages.