Clinical trials are the cornerstone of advancing cancer treatments, with nearly every therapy used today rooted in past trials. Despite their critical role, enrollment in clinical trials remains disappointingly low, with only 2-8% of eligible cancer patients participating. Misconceptions, logistical challenges, and lack of diversity compound the issue. Here's a closer look at the importance of clinical trials, the persistent gaps, and how myths surrounding participation can be addressed.
What Are Clinical Trials?
Defined by the American Cancer Society, clinical trials are research studies involving human volunteers to test new drugs, diagnostics, or prevention methods, comparing them against standard treatments. These trials progress through multiple phases, ensuring safety and efficacy before broad adoption.
Diversity: A Persistent Challenge
Diverse participation in clinical trials is critical because responses to treatments can vary by ethnicity, age, geography, and socioeconomic status. However, a 2020 FDA study revealed alarming gaps:
- Non-Hispanic Whites: 75% of participants (59% of the U.S. population).
- Hispanics: 11% of participants (19% of the population).
- Blacks or African Americans: 8% of participants (14% of the population).
Geographic diversity is also an issue, as most trials occur in urban academic centers, leaving rural populations underserved.
Debunking Myths About Clinical Trials
Many patients avoid trials due to misinformation. Here are common myths and the truths behind them:Myth: Placebos mean receiving no treatment.
Truth: Some trials use placebos to prevent bias within the study. Patients will be made aware if their study includes placebos, but they won’t know if they personally are receiving a placebo or not. Importantly, if there is a treatment available for their cancer, they will receive treatment. If a placebo is used in an oncology clinical trial, it’s typically used in addition to the standard of care, not in place of standard of care.
Myth: Trials are for “guinea pigs.”
Truth: It takes years of research and many approval steps before any drug makes it to a clinical trial. All patients who enroll in trials receive exceptional attention and care from the medical team. The new treatment only makes it to the clinical trial stage because research indicates it has the potential to deliver better patient outcomes—longer progression-free survival, fewer side effects, or both. Unlike guinea pigs, clinical trial participants may directly benefit from the treatment being tested.
Myth: Trials are a last resort.
Truth: Clinical trials are open to all cancer patients at all stages of their diagnosis and should be part of the discussion from the time of initial diagnosis. The National Comprehensive Cancer Network provides guidelines representing the collective wisdom of how cancer should be treated, and they very expressly advocate clinical trial participation: “The best management for any patient with cancer is within a clinical trial. Clinical trials offer patients access to the most current cancer care, treatment by experts, carefully monitored results tracking, and the ability to help other patients with cancer.”
Myth: Trials are expensive.
Truth: Most health insurance policies are required by law to cover the routine costs of a clinical trial. This would include care that is normally done as part of standard of care. They cannot deny insurance coverage as long as the trial is an approved trial and the patient is not seeking care outside of their network. The insurance company does not have to pay for trial-related visits, the study drug, or additional blood work or scans that are specifically related to the clinical trial itself. Those trial-related visits and treatments are often covered by the trial sponsor.
Myth: Logistical hurdles make trials inaccessible.
Truth: Facility access can definitely pose logistical challenges for patients hoping to participate in a clinical trial. Depending on the trial design, a patient may be able to participate in a trial but still receive their care locally. Alternate approaches can use telemedicine visits to follow-up on drug compliance and side effect reporting. Lab draws can sometimes be done at local facilities, and drugs can be shipped directly to the patient. Additionally, many trials are designed to coincide with standard-of-care visits, making it easier for patients to participate. Some sponsors are also willing to offset the cost of necessary travel via assistance with lodging or by providing a travel stipend.
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