Journal
EXPERT REVIEW OF PHARMACOECONOMICS & OUTCOMES RESEARCH
Volume 15, Issue 4, Pages 561-564Publisher
TAYLOR & FRANCIS LTD
DOI: 10.1586/14737167.2015.1037835
Keywords
economic evaluation; oncology; survival analysis; treatment crossover; treatment switching
Funding
- GSK
- Eisai
- Pharmaceutical Oncology Initiative
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Treatment switching has become an important issue in the development and approval of new drugs, particularly in oncology. Randomized controlled trials (RCTs) represent the gold standard for evaluating the effectiveness of interventions, but often patients randomized to the control group are permitted to switch onto the experimental treatment at some point during the trial. This is important, because standard statistical approaches used to analyze RCTs compare groups as randomized, based upon an intention-to-treat principle. When patients in both groups receive the new drug, such analyses do not provide an accurate estimate of the comparative effectiveness of the two treatments. This may lead to inappropriate decision-making - cost-effective drugs may not be approved. Limited healthcare finances may be used inefficiently. Health-related quality-of-life and lives may be lost.
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