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2.7 Assessment of differences between the trial setting and the Australian setting after listing
Trials tend to enrol patients who are healthier, have fewer comorbidities or concomitant medications, and have more stringent monitoring than the target population. Trials are usually underpowered
pbac.pbs.gov.au/section-2/2-7-assessment-of-differences.html
Page last updated: September 2016
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Appendix 5 Translating comparative treatment effects of proposed surrogate measures to target clinical outcomes
a medical condition in the long term. Ensure that the TCO is consistent with the health states defined in the natural history of the disease or condition. In some cases, more than one TCO may be required
pbac.pbs.gov.au/appendixes/appendix-5.html
Page last updated: September 2016
