“Clinical research is the rocket fuel for better treatments, more accurate diagnoses, and ultimately, cures,” said José Baselga, MD, PhD, physician-in-chief and chief medical officer at Memorial Sloan Kettering Cancer Center (MSKCC), in New York, New York.
WHY PATIENTS SAY “NO”
Patients are simply not enrolling in enough clinical trials to fuel cancer research. Memorial Sloan Kettering Cancer Center conducted a survey of almost 600 physicians and more than 1500 consumers age 18 to 69 years. Of the consumers who responded, only 35% said they would be likely to enroll in a clinical trial, and as few as 40% of respondents indicated having a positive impression of clinical trial participation.1 Why is this?
Of those who completed the survey, responses indicated
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- 34% were concerned they would feel like guinea pigs
- 35% did not trust the efficacy of an unproven treatment
- 46% were worried about being given a placebo
- 48% were concerned that the trial location would be inconvenient
- 50% did not know whether medical insurance or Medicare would cover the cost (it usually does) or if they would be responsible for out-of-pocket expenses, and
- 55% were worried about the safety and side effects of the study medication.1
In another study, researchers found fear of being the subject of an experiment or of being randomized were the most common reasons patients gave for not participating in a trial. Patients also cited the unknown toxicity and side effects of chemotherapy as another reason for not participating in a trial.2 After discussing their treatment plans with their clinicians, some patients do not want to veer from the proposed treatment and enroll in a clinical trial.
PHYSICIAN PERCEPTIONS
Physicians surveyed for the MSKCC study agreed with many of the barriers their patients presented concerning clinical trial participation. Side effects and safety comprised 63% of their concerns; 63% of doctors were as apprehensive as their patients about the possibility of their patients receiving a placebo instead of the drug. Fifty-three percent of the responding physicians worried about their patients perceiving themselves as guinea pigs.
Interestingly, more than half of the physicians (56%) admitted that the only time they discussed clinical trials with their patients was late in the course of treatment. Only 32% brought up the possibility of clinical trial enrollment early on. In fact, 28% of participating physicians considered clinical trials to be a treatment of last resort.1
One negative aspect to clinical trial participation cited by a number of physicians was the time consuming process of enrolling patients in these trials. The heavily scheduled clinician must take extra time to evaluate the trial, enroll each patient, explain the details of the study, and be available to answer ongoing questions. Thus, lack of time may present a barrier to giving potentially eligible patients information about clinical trials and encouraging them to enroll.2
