Most cancer clinical trials don’t meet their enrollment targets and it has been previously thought that patient reluctance was behind this. Now a new study published today in the Journal of the National Cancer Institute, led by researchers from the Fred Hutchinson Cancer Research Center in Seattle challenges that by suggesting that other factors are primarily responsible.
“Patients are often fearful of participating in clinical trials, and many consider trial participation as appropriate only for those with no other choices. This is unfortunate since patients receive excellent cancer care in trials,” said Dr. Joseph Unger, a health services researcher and biostatistician who led the study.
Previous research led by Unger looked at these patient reasons for reluctance, finding some of the most common reasons for patient rejection of clinical trials were dislike of being randomized onto a particular arm of a clinical trial, unease with the trial protocol or apprehension about treatment side effects.
However, the new study suggests that patient choice is not as responsible for the low rate of participation in trials as previously thought. The research also involving researchers from Columbia University and the American Cancer Society looked at 13 studies involving almost 9,000 cancer patients and found that over half of patients didn’t have a trial available to them at their institution. Almost a quarter were ultimately deemed ineligible for a trial they applied for, but when patients were offered the chance to participate in a clinical trial, about half did.
“These findings illustrate the need to re-examine the way we think about patient participation in clinical trials. Most of the time it’s not up to the patient. Instead, structural and clinical barriers are the reasons more than 3 out of 4 patients do not participate in trials,” said Unger.
The overall trial participation rate for the studies analyzed by Unger and team was 8 percent, notably higher than the typically cited rates of 2 to 3 percent. Unger indicated that this is because about twice as many patients participate in pharmaceutical company sponsored trials than government sponsored trials, a factor which is often overlooked.
“There is one large difference between pharma-led and government-sponsored trials. Pharmaceutical companies provide substantially more resources to reimburse cancer centers for patient enrollments to their trials. In contrast, government sponsored trials have limited per-capital reimbursement rates that have not changed substantially over time,” said Unger.
But if a suitable clinical trial is not available nearby, can people travel to other centers for clinical trials?
“Patients can travel to other centers and many do, but many more are hindered by the constraints of travel, having to take time off work, family constraints, and the costs of having to both travel to another location and potentially stay there for long periods to receive their care,” said Unger, also mentioning that people with greater financial means are more likely to be able to do this than people less financially secure.
Before centers can conduct clinical trials there are many requirements for them to satisfy in terms of staff training, expertise and infrastructure. This means that most clinical trials are often conducted at big treatment centers, sometimes leaving patients who live far away from these centers with difficult choices. Some progress is being made with several schemes in the U.S. designed to make clinical trials more accessible for those who live further away from big centers, but currently the majority of trials are run at big centers often in the middle of big cities.
Doctors and clinical trial coordinators are constantly trying to find more methods to increase patient enrollment in clinical trials. One piece published here on Forbes Health last week, suggested that social media could be used to facilitate greater involvement of patients in trials. Unger is positive about the possibilities that this approach opens up.
“For many patients, simply accessing a clinical trial is problematic, and using social networks and social media could be one valuable approach to shrinking the divide between patients and access to trials. The stories about patients reaching out to their physicians via social media are emblematic of the idea that patients who understand the benefits of trial participation are much more willing to participate in trials than conventional wisdom suggests,” said Unger.
Clinical trials missing their recruitment targets not only disadvantages patients who could benefit from access to the newest therapies, but also slows down the progress of cancer research. Trials that miss or are slow in getting to their recruitment targets often take longer to complete and make it more difficult for researchers to draw definitive conclusions about how the new treatment has fared.
“Clinical trials provide protocol directed, guideline-based, best practice care, performed by teams of trained professionals dedicated to the patient’s care. Moreover, clinical trials offer access to the newest available treatments. So for many patients, participation in a clinical trial can actually represent a desirable choice for the cancer care,” said Unger.
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