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Clinical trials: are they a good buy?
C L Bennett1, J R Adams, K S Knox
1Chicago Veterans Affairs Healthcare System/Lakeside Division, IL 60611, USA. cbenne@northwestern.edu
Summary
Clinical trials cost about the same or slightly more than standard care. Many insurers now cover patient care in qualifying clinical trials, easing participation barriers.
Area of Science:
- Oncology
- Health Economics
- Clinical Trial Management
Background:
- Restrictive insurer policies on clinical trials are often based on cost concerns.
- Reimbursement denial by insurers is a significant barrier to clinical trial participation.
Purpose of the Study:
- To review empirical data comparing clinical trial costs to standard care.
- To summarize policy initiatives for clinical trial insurance reimbursement.
Main Methods:
- Searched electronic and print data for oncology clinical trial cost studies.
- Gathered policy information from professional societies and web searches.
Main Results:
- Five pilot studies (377 patients) found clinical trial costs ranged from 10% lower to 23% higher than standard care.
- Medicare, 14 states, and private insurers now cover patient care in qualifying clinical trials.
Conclusions:
- Phase II and III clinical trials incur modest cost increases over standard treatment.
- Growing policy support for clinical trial reimbursement initiatives is evident.
- Economic data from large studies may encourage permanent reimbursement for all trial phases.