Fitness

Can Joining a Clinical Trial Help You Beat Cancer?

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4 months ago

May 28, 2024

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Can Joining a Clinical Trial Help You Beat Cancer?

Cancer clinical trials are often considered “top shelf” care because of the access to cutting-edge therapies and leading specialists. But in reality, people participating in clinical trials for anti-cancer drugs don’t live any longer when compared with people with cancer receiving routine cancer treatment, according to a study published in JAMA this month.

Oftentimes cancer patient advocacy websites or funding websites present clinical trials as offering some medical advantages over standard treatment because of closer monitoring or higher quality care, says study co-author Jonathan Kimmelman, PhD, associate professor and researcher in the division of experimental medicine at McGill University in Montreal.

“But that’s not what we found in our paper — instead, there doesn’t seem to be any survival advantage for cancer patients participating in clinical trials,” says Dr. Kimmelman.

Making the Decision to Participate in a Clinical Trial Requires Accurate Information

Researchers set out to find if the conventional wisdom about clinical trial survival benefit held up to scientific scrutiny. The goal was not to discourage people with cancer from joining trials, but rather to give them accurate information so that each person can make their own decision about what’s best for them and their loved ones, says Kimmelman.

Beyond the potential side effects of an unapproved medication, a person makes other sacrifices to be in a clinical trial, according to an accompanying editorial published in JAMA. “When time is limited (in the last year of life) and treatments have small potential benefits, how and where patients spend their time becomes increasingly relevant,” the authors write.

To carry out the meta-analysis, investigators analyzed 39 studies for a total of 85 comparisons of trial participants and routine care patients. The goal was to see whether cancer patients benefit from participating in clinical trials, regardless of whether they receive the treatment or the control, says Kimmelman.

“If you’re a patient and you’re getting a given treatment, let’s call it treatment A, do you have better outcomes if you receive that treatment in a trial versus if you receive that same treatment outside of a trial? Treatment A could be the experimental drug or it could be the control drug — the point is, if you receive a drug in a trial, do you have different outcomes compared with receiving the exact same drug outside of a trial?” he explains.

The initial analysis showed a statistically significant overall survival benefit for trial participants. But when Kimmelman and his team only considered high-quality studies, the survival benefit went down. Poorer quality studies didn’t control for factors that could influence the findings, such as comorbidities (other diseases a person might have at the same time as cancer), race, or cancer stage.

Finally, once the investigators adjusted for publication bias, there was no significant benefit for clinical trial participants. Publication bias occurs because often study results aren’t published when the result doesn’t show a drug in a positive light, and so those studies would never make it into an analysis like this one.

Why Do Drugs Seem to Perform Better in Clinical Trials?

Patients often survive longer in trials or experience a bigger positive treatment effect than they do taking the same drug in the “real world,” says Kimmelman.

“That gap between effectiveness and efficacy might lead someone to think that patients have better outcomes in trials, when in reality, a lot of that is because trials tend to enroll ‘the healthiest of the sick’ and so they tend to have better outcomes,” he says.

Participants in trials are generally younger, fitter, have fewer comorbidities, and have socioeconomic advantages such as more education or higher income.

“They also tend to be more motivated in adhering to their medications,” says Kimmelman.

Survival Benefits Are Just One of Many Reasons People Sign Up for Clinical Trials

In some ways, this analysis is disappointing because you would hope that clinical trials would help extend survival and improve health outcomes, says Norah Crossnohere, PhD, assistant professor and patient-centered outcomes researcher at The Ohio State University in Columbus, who was not involved in this trial.

“But even when folks don’t expect clinical trials to bring them improvements in health outcomes, they often still continue to sign up,” says Dr. Crossnohere.

Sometimes that’s because they are altruistic and want to contribute to science or help other people with cancer, she says. “Plus, in some cases, especially if the condition is rare, these trials could offer some community and connection with other people who are dealing with the same things they are,” she says.

The Mantra ‘Trial Participation Is the Best Treatment Option’ Needs to Be Retired

There’s another side to these findings that some people might find reassuring, says Kimmelman.

Many people face barriers to participating in clinical trials because they live too far away or are deemed ineligible because of another medical condition, he says.

“That can be incredibly disappointing for patients, especially for cancer patients who are desperate to have more options available for them. Our findings should reassure those patients that they are not medically disadvantaged, at least with respect to survival, merely because they are unable to access a clinical trial,” says Kimmelman.

There are also people who may not want to enroll in trials because they choose to focus on palliative care and symptom management. Those individuals may feel family and societal pressure to “keep fighting,” write the authors of the JAMA editorial. For these individuals, the new study results may be validating.

There are many valid reasons to participate in a clinical trial as well as valid reasons not to, the editorial authors point out. But based on these findings, patients shouldn’t be influenced by the idea that trial participation always has life-extending benefits. The mantra “Trial participation is the best treatment option” needs to be retired, they write.