Issues in Randomization Outline
Issues in Randomization Outline
Issues in Randomization Outline
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Blocked <strong>Randomization</strong> Example:Flu Vacc<strong>in</strong>e Dose Escalation Study• Phase I dose-f<strong>in</strong>d<strong>in</strong>g flu vacc<strong>in</strong>e study• Investigate 6 dose levels <strong>in</strong> a bl<strong>in</strong>ded,placebo controlled study– Considered s<strong>in</strong>gle (one nare) and doubledose (both nares) of 0.25mg, 0.5 mg, and1mg adm<strong>in</strong>istered <strong>in</strong>tranasally• Primary outcome: safety and tolerability82Blocked <strong>Randomization</strong> Example:Flu Vacc<strong>in</strong>e Dose Escalation Study• Dose cohorts had 5 active and 2 placebosubjects• Randomized block design, block of size 7• Order of the 5 active and 2 placeboassignments randomly permuted for eachdose group83Phase II• A study to test whether a new treatment hasan anticancer effect (for example, whether itshr<strong>in</strong>ks a tumor or improves blood testresults) and whether it works aga<strong>in</strong>st acerta<strong>in</strong> type of cancer• Surrogate endpo<strong>in</strong>ts– Note: many th<strong>in</strong>gs shr<strong>in</strong>k tumors and donot improve survival/quality of life(ACRT/SCTS story)28
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