BACKGROUND:
Enrollment in interventional therapeutic clinical trials is a small fraction of
all patients who might participate given reasonable access.
METHODS:
A
hierarchical approach is utilized in measuring staged participation from trial
availability to patient enrollment. Our framework suggests that concern for
justice comes in the design and eligibility criteria for clinical trials;
attention to beneficence is given in the eligibility and physician triage
stages. The remaining four stages rely on respect for persons. An example is
given where reasons for nonparticipation or barriers to participation in
prostate cancer clinical trials are examined within the framework. In addition,
medical oncology patients with an initial six month consultation are tracked
from one stage to the next by race using the framework to assess participation
comparability.
RESULTS:
We
illustrated seven transitions from being a patient to enrollment in a clinical
trial in a small study of prostate cancer cases who consulted SKCCC Medical
Oncology Department in early 2010. Pilot data suggest transition probabilities
as follows: 65 % availability, 84 % eligibility, 92 % patient triage, 89 %
trials discussed, 45 % patient interested, 63 % patient consented, and 92 %
patient enrolled. The average transition probability was 77.7 %. The average
transition probability, patient-trial-fit was 50 %; opportunity was 51 %, and
acceptance was 66.7 %. Trial availability, patient interest and patient
consented were three transitions that were below the average; none were
statistically significant.
CONCLUSIONS:
The
framework may serve to streamline comprehensive reporting of clinical trial
participation to the benefit of patients and the ethical conduct of clinical
trials
Source:
Removing barriers to participation in clinical trials, a conceptual framework
and retrospective chart review study. Kanarek
NF
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