While many patients express a willingness to participate in a cancer-related clinical trial, “only a small fraction” end up enrolling due to “barriers that make participation difficult or even impossible,” says a new study.
According to the report on “Barriers to Patient Enrollment in Therapeutic Clinical Trials for Cancer” produced by the American Cancer Society Cancer Action Network (ACS CAN), the consequence is that about 20% of cancer trials fail due to insufficient patient enrollment.
Enrollment in a cancer clinical trial is a multi-step process. While participating is viewed as a patient decision, the study says, “it is notable that the patient is not presented with the option until the last step, which is only reached if previous barriers have not been encountered.”
The report, analyzing studies across a variety of settings, drew several conclusions:
- 56% of patients will not have a local trial available for their cancer
- 17% will be ineligible for a trial due to exclusion criteria
- Many eligible patients will not be asked by the provider to enroll
- Only 27% of cancer patients will have the option to enroll in a clinical trial
Patient hesitance is not a significant factor. “Typically, greater than 50% of eligible patients who are asked to participate agree to do so,” according to the report.
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The scramble for clinical trial participants is only going to become more intense, the study suggests. Clinical trials are increasingly designed around very small, genetically defined subsets of cancers, “making finding eligible patients even more difficult.”
One possible solution is to involve patients in the design of clinical trials. It’s been found to improve their “appeal to patients and accrual success,” according to the report. It’s also an underutilized resource, many experts say. (For more on this topic, read Patients are Experts in Their Own Right)
“Clearly the cancer community needs to do more to expand the reach of available trials and make sure trials are designed so that those who want to participate can,” said Christopher W. Hansen, president of ACS CAN.
Hoping to improve patient enrollment, ACS CAN and 14 other organizations from all sectors of the cancer research community developed a set of consensus recommendations. Sample suggestions include making the discussion of specific trial options a more regular part of the doctor-patient treatment decision; increasing funding for trial-support personnel to help patients understand, enroll in, and manage their trial; and helping patients afford the added costs that occasionally result from trial participation.
The report was sponsored in part by Genentech, IQVIA, and Merck.
Author: Michael Causey