Key Words
Clinical trials, barriers to enrollment. (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary.)
Summary
In one of the only studies to systematically assess cancer patients’ feelings about taking part in clinical trials, researchers have identified a number of barriers to enrollment. Two of the main barriers are patients’ concern that joining a trial might reduce their quality of life and that they would receive a
placebo. The study’s authors hope these findings can help research teams develop ways to address perceived problems and boost trial enrollment.
Source
Lancet Oncology, February 2006 (see the journal abstract).
(Lancet Oncol. 2006 Feb;7(2):141-8)
Background
Advances in treatment and care for patients with cancer and other serious diseases come about as a result of findings from clinical trials. However, the number of patients who participate in clinical trials is very small. For example, only about three percent of adult patients with cancer take part in clinical trials.
Difficulty recruiting enough patients for a trial in a timely fashion often means that it takes longer than planned to complete the trial. Improving patient enrollment in cancer clinical trials would allow trials to proceed more quickly, which would help to advance treatment and care at a faster pace. To improve patient enrollment in trials, however, researchers must understand and address the reasons why many patients do not participate.
The Study
Researchers in Canada searched the medical literature for original research studies in which patients were asked questions about their attitude about participating in cancer clinical trials. The researchers pooled information from these studies to estimate which issues patients identified most often as barriers to clinical trial participation.
The study’s principal investigator was Edward J. Mills, Ph.D., of McMaster University in Hamilton, Canada.
Results
The researchers analyzed information from 33 studies performed in four countries (the United States, Canada, the United Kingdom, and Denmark). Some of the studies questioned patients who were enrolled in clinical trials; others questioned patients who were eligible to enroll.
The following issues were identified most often by patients as barriers to participation in a clinical trial:
- fear that their quality of life might be reduced
- reluctance to accept the chance that they might get a placebo
- concern about potential side effects
- concern that treatments under study in the trial are not their best option
Other barriers mentioned often by patients included a reluctance to be randomly assigned to treatment, feeling that trial participation was inconvenient to everyday life, and feeling that their personal doctor (rather than the trial’s doctors) should make treatment decisions. Roughly a fifth of patients mentioned being concerned about losing control over decision-making, feeling coerced to join a trial, and disliking being experimented on. Some patients also described concern about cost or health insurance as a barrier to trial enrollment.
Limitations
The study focused on patient-perceived barriers to clinical trial enrollment and did not address the reasons why many patients are not asked by doctors to participate in a trial, the authors write. Doctors’ reluctance to refer their patients to clinical trials is a major barrier in need of further study and attention.
An additional limitation, the authors note, is that because all of the studies included in the analysis were conducted in developed countries, they cannot determine how applicable the findings would be in developing countries.
Comments
The authors comment that to their knowledge, this study is the first published systematic review to assess the concerns of patients with cancer about clinical trial participation.
“These findings should aid those who have a role in the planning, recruitment, and conduct of clinical research to make it more appealing for people living with cancer to enroll,” they write, adding: “We think that most of the concerns identified in our study can be alleviated with directed educational strategies.”
This study’s findings are similar to those of other recent studies of patient-perceived barriers to enrollment in cancer clinical trials, says Andrea M. Denicoff, R.N., M.S., A.N.P., a nurse specialist in clinical trials with the National Cancer Institute’s Cancer Therapy Evaluation Program.
“Studies like these are a valuable reminder to everyone involved in clinical trials to pay attention to the patient factors that affect enrollment,” she says.
One of the patient concerns identified in this study - fear of being assigned to receive a placebo - is something of a misconception, says Denicoff. “Patients in clinical trials of cancer treatments rarely receive placebos,” she says. Typically, patients are randomly assigned to receive either the current standard treatment for their disease or an experimental treatment, or standard treatment plus an experimental treatment.
As a major supporter of cancer clinical trials, the National Cancer Institute (NCI) is aware of the need to improve access to trials for all patients with cancer, says Denicoff. Initiatives that NCI is helping to fund to achieve this goal include
- making grants to cancer centers to develop strategies for increasing and sustaining patient enrollment in clinical trials. Such strategies include providing staff whose job is to help patients better understand clinical trials, providing information about clinical trials in multiple languages, and helping patients navigate the health care system.
- providing infrastructure support to cancer doctors in private practice to participate in clinical trials, so that patients can be in a trial while continuing to be treated in their own doctor’s office, avoiding the need to travel to a distant cancer center.
- expanding the role of patients in the process of designing clinical trials, so that patients’ practical concerns are addressed when a trial is being planned.
- making grants to develop Patient Navigator Research Programs. Navigators are trained to work with the health care team and help guide patients and their families through the treatment process, helping to overcome common barriers to obtaining timely and appropriate cancer care.
- more information on some of these interventions being studied to overcome barriers for patients participating in clinical trials is available on the Association of American Cancer Institutes’ Web site as it is funded through a public-private partnership.
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