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Removing barriers to participation in clinical trials, a conceptual framework and retrospective chart review study.

Abstract：

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.

journal_name

Trials

journal_title

Trials

authors

Kanarek NF,Kanarek MS,Olatoye D,Carducci MA

doi

10.1186/1745-6215-13-237

subject

Has Abstract

pub_date

2012-12-10 00:00:00

pages

237

issn

1745-6215

pii

1745-6215-13-237

journal_volume

13

pub_type

杂志文章

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