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Abstract:
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Cumulative risk or overall survival rates have been frequently used as outcome measures in phase III clinical trial and their estimates have been used for power calculations in designing phase III intervention trials. However, the effectiveness of the intervention is often measured for other endpoints in Phase I/II trial since the followup time is often too short to have enough events for cumulative risk or survival estimates. As a result, end points other than the overall survival rates or survival estimates reported in other studies have been used for power calculation for a new study. In order to fill in the information gap of survival rate or cumulative risk between Phase I/II and phase III trial, use of modified Weibull risk function is suggested. A modified risk function modified by drug's half life, timing and number of drug doses is used for estimating longterm cumulative risk or survival estimates of intervention group. These estimates can be useful in planning a future study and the outcome measures in Phase III study can be used in power calculations.
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