Why Don't Patients Enroll in Clinical Trials?
10/17/2002
Introduction
For more than 15 years, estimates suggest that only 2 to 3% of cancer patients
enroll in clinical trials. For other diseases and conditions, the numbers are
equally low. Such low numbers immediately raise a simple question: why? What's
the problem? Why don't more patients enter clinical trials? Or maybe 2% is the
right number? It's a simple question with a $700,000 answer-or the estimated
cost per day of delays in recruiting patients to clinical trials for a new drug.
Earlier this month, the editors of the leading journal Cancer decided to tackle
this question head-on. In most clinical trials, a clinical research associate
(CRA), rather than a physician, is responsible for talking with a patient and
explaining the risks and benefits of a trial. In two articles in Cancer on the
subject, researchers decide to ask these clinical trials recruiters themselves:
what makes enrolling patients in trials difficult?
Three Factors
The CRAs identified three types of factors that delayed trials: physician
factors, patient factors and, most importantly, system factors. Physician
factors relate largely to the fact that many physicians decide that a
particular patient would not be able to handle a trial-perhaps physically,
mentally or emotionally. Physicians often make this determination without
talking to the patient and regardless of whether or not a patient meets the
criteria laid out by the study. In other words, whether a physician "buys into,"
or believes in a study, turns out to be important.
Patient factors are also relevant. According to CRAs, patients' major concerns
are logistical: they worry about the extra clinic visits, tests and
questionnaires that accompany many trials. Some patients also worry whether or
not they will get the best treatment, or are just serving as "guinea pigs." Most
important for patients, however, is information: patients with the most
accurate and up-to-date information are the most likely to participate in
trials; those with the least information are the least willing to participate.
However, CRAs identified systems issues as the most important factor of all.
Systems issues are really just a reflection of the complex processes surrounding
general health care and clinical trial design in the United States. Insurance
coverage for a trial is one example of a systems issue. Will participation be
covered? How many phone calls will it take to find out? Other examples of
systems issues include the inability to schedule sufficient time with a
physician to discuss a trial, or the fact that some trials have tight time
frames and require patients to make enrollment decisions within a few days of
first learning about the trial.
It's All About Information
In an invited editorial response to these findings, Dr. Martin Tattersall, a
cancer researcher in Australia, acknowledged that both physicians and CRAs can
do a better job of explaining individual trials and the trials process to
patients. In the end, he warns, clinical trials need to avoid becoming too
corporatized, and he suggests that information, and patients' clear
understanding of clinical trial enrollment, will remain essential to increasing
the numbers of patients who participate.
References:
Eva Grunfeld, Louise Zitzelsberger, Marjorie Coristine, Faye Aspelund. Barriers
and facilitators to enrollment in cancer clinical trials: Qualitative study of
the perspectives of clinical research associates. Cancer
(Oct 2002) 95:1577-1583.
James R. Wright, Dauna Crooks, Peter M. Ellis, Deborah Mings, Tim J. Whelan.
Factors that influence the recruitment of patients to Phase III studies in
oncology: The perspective of the clinical research associate. Cancer (Oct 2002)
95:1584-1591.
Martin Tattersall. Cancer clinical trial recruitment: The emerging role and
perspectives of clinical research associates and data managers. Cancer (Oct
2002) 95:1397-1400.
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