ORLANDO, FL—Getting patients to enroll in clinical trials is known to be a challenge, and a survey presented at the ASCO Annual Meeting sheds some light on the reasons.
The survey found that although patients and physicians agree that clinical trials are important for improving cancer treatment, they disagreed about whether patients would derive benefit from participating in such trials. Seventy nine percent of physicians, but only 57% of patients, felt strongly that they would benefit from participation in clinical trials. Also found was that oncologists underestimated patients' fear of side effects when receiving experimental treatment.
“Patients were more likely to consider enrolling in clinical trials for advanced disease or if treatment has failed,” reported Neal J. Meropol, MD, a senior member of the Division of Medical Science at Fox Chase Cancer Center and Director of both the Gastrointestinal Cancer Program and Gastrointestinal Tumor Risk Assessment Program there.
“Also, oncologists overestimated the importance of patients' lack of knowledge about clinical trials and underestimated patients' fear of side effects and suspicion of the medical establishment. Understanding these barriers could help us improve the rate of participation.”
The survey was sent to 478 oncologists and completed by 136. Eighty-one percent of oncologists were male, with a median age of 49 (range, 32–71); 61% worked in a non-academic setting; and 14% were non-white.
Physicians were asked to distribute 10 questionnaires to their patients; 159 patients completed the survey. Fifty-three percent of responding patients were female, with a median age of 55 (range, 22–85); 11% were non-white; and 57% received education beyond high school.
“These numbers [of patients] were small, but we depended on physicians to distribute the surveys,” Dr. Meropol said.
The survey was based on ranking statements using a 5-point Likert scale, from 0 defined as “not at all”; and 5 as “strongly agree.” Although focus groups suggested that patients would understand how to complete a survey by ranking responses, patients who filled out the survey seemed to be confused as to how to do this, Dr. Meropol said.
Oncologists did a good job of answering the survey correctly, he said. “I am more concerned about the representativeness of patients' responses to the survey than about the responses of the physicians.” We were stunned by the incorrect responses from patients. Ranking questions foiled them.”
Patients' responses indicated that 85% believed in the importance of clinical trials, 72% were interested in clinical trials, and 66% were interested in learning more about them.
Sixty-five percent said they were more likely to consider a clinical trial after failure of first therapy, 84% had heard about clinical trials, but 36% said they really didn't understand what clinical trials were; 52% expressed financial concerns related to clinical trials, and only 37% said they would be willing to travel to participate in a trial.
Enrollment Better at Academic Centers
The Discussant for the paper, Christopher Daugherty, MD, Professor of Hematology/Oncology at the University of Chicago Pritzker School of Medicine, called the study “an excellent example of a study of attitudes and understanding regarding participation in a cancer clinical trial.”
He noted that less than 5% of all cancer patients participate in clinical trials, but that enrollment is 10 times higher at academic centers than at tertiary care centers. He said that 10% of all oncologists are responsible for enrolling 80% of subjects for clinical trials.
“Also, physicians overpredict how many patients they will enroll,” Dr. Daugherty said.
Patients and physicians expressed concern about random assignment as a barrier to participation, and patients expressed fear of placebo as another.
“There are no placebo arms in cancer trials, so this suggests that patients don't understand what trials are all about. This gives us an idea of what patients and physicians in the real world think,” he said.
Dr. Daugherty said whether patients understand the implications and risks of clinical trials is a concern. Other questions are whether eligibility criteria are too strict and whether there are too few trials.
“It is not clear whether we have resources to conduct more studies,” he said.