ABSTRACT: Clinical Trials: Are They a Good Buy?
PURPOSE: Concern that clinical trials may be too costly has been
used to justify traditionally restrictive insurer policies regarding
clinical trials. Additionally, fear of insurer reimbursement
denial can be a significant barrier to clinical trial participation.
In this study, we reviewed the empirical data on costs of clinical
trials versus standard care and summarized the current status
of policy initiatives related to clinical trial insurance reimbursement.
CONCLUSION: Findings from small pilot studies suggest that phase
II and III clinical trials result in at most modest increases
in cost over standard treatment costs.
Also, an increasing number
of policy makers have decided to support clinical trial reimbursement
initiatives. It is hoped that economic data from large observational
studies will facilitate widespread and permanent decisions that
support reimbursement for phase I, II, and III clinical trial
12/03/2001; Journal of Clinical Oncology
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