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Clinical trials are studies with volunteers that help researchers learn how to slow, manage, and treat different diseases.
There are four phases of clinical trials that each help scientists answer different questions.
Phase 1 clinical trials are the first step in testing a new treatment in people. They focus on evaluating the safety, side effects, best dose, and timing of a new treatment, according to the National Cancer Institute (NCI).
Phase 1 clinical trials usually include a small number of patients who have not been helped by other treatments.
In the past, participants in phase 1 trials for cancer treatment generally had low tumor response rates. And, because phase 1 trials are focused on assessing safety of treatments, doctors have hesitated to refer patients to these trials.
As a result, enrollment in phase 1 cancer clinical trials has been slow.
However, an August 2022 study suggests phase 1 clinical trials may offer more benefit to cancer patients than previously thought due to improvements in drug development.
Let’s explore the significance of this study and what it means for Latinos.
Potential Benefits of Phase 1 Trials
Published in the Lancet by colleagues from NCI and UT MD Anderson Cancer Center, the study surveyed the last two decades of phase 1 clinical trials focused on treating solid tumors.
Over that period, researchers found that the number of trial participants whose tumors shrank or disappeared nearly doubled. They also found that the percentage of patients whose tumors stopped growing for a time also increased.
The risk of death caused by a new treatment being tested remained steady at less than 1%.
“Participating in phase 1 trials has more potential for clinical benefit than is commonly believed, largely due to the development of modern cancer drugs, like targeted therapies, immunotherapies, and new combination therapies,” said study author Dr. Naoko Takebe of NCI.
“So I hope this analysis will have a positive impact on the enrollment of patients into phase 1 trials by doctors, who may feel more comfortable referring patients.”
If more patients enrolled in phase 1 clinical trials, researchers could develop new cancer treatments faster – potentially saving lives.
But again, oncologists must overcome their hesitancy about phase 1 trials, and offer enrollment opportunities to cancer patients who have run out of effective treatment options, Dr. Takebe said.
“The patients ultimately decide whether they should participate, but we, the oncologists, have to give them that option,” she said.
Importance of Latinos in Clinical Trials
Cancer is the top cause of death for Latinos.
Worse, Latino cancer cases are expected to rise 142% between 2010 and 2030.
Latinos also suffer higher rates of liver, stomach, and cervical cancer than their White peers, due to structural health inequities that impact access to cancer prevention, detection, and treatment services.
Unfortunately, Latinos are historically underrepresented in clinical trials, making it difficult for researchers to learn more about Latino health and find cancer treatments tailored for this group.
There are a variety of reasons why Latinos do not participate in clinical trials, many of which are caused by those same structural health inequities.
But studies like Takebe’s might help more oncologists discuss clinical trial opportunities with Latino cancer patients.
Dr. Amelie Ramirez, Director of Salud America! at UT Health San Antonio is also helping tackle this issue. She’s creating new ways to encourage Latinos to volunteer for cancer and Alzheimer’s clinical trials, with support from Genentech, a member of the Roche Group.
Ramirez is showcasing open clinical trials and uplifting the stories of Latino clinical trial participants on her Salud America! website.
“Latinos in clinical trials are not only helping themselves, but they are also building a future with better treatments that can help their families and communities in the future,” Ramirez said.
How Can I Learn More About Clinical Trials?
If you’re interested in enrolling in a clinical trial, the first step is to talk with your doctor.
It’s important to get all the information you need to make an informed decision about participating in a clinical trial.
The US Food & Drug Administration (FDA) recommends asking your healthcare provider the following questions:
- What is the evidence that the investigational product might help me?
- How will you check to see if the investigational product is working?
- Are there any concerns that the investigational product could be unsafe?
- How closely will I be monitored if there are problems?
- Who do I call if I’m concerned that there is a problem?
Additionally, the FDA recommends taking notes during your discussion with your healthcare provider to ensure you fully understand the potential benefits and risks of the trial.
You should also ask for contact information for the trial, and before signing any documents, discuss the trial with trusted family members.
Finally, if you’re not satisfied with the information given to you about the trial, trust your instincts, and don’t enroll.
You can stop participating in a clinical trial at any time.