Keywords: open-label, blinding
Room: Wilson C
The double-blind randomized study is the gold standard for reducing bias in a clinical trial, but it is often not feasible due to the complexity of the regimens or the lack of an available placebo. In an open-label study, the investigator and the participant will know the randomized treatment assignment. However, aggregate summarizations of the data by treatment group should be avoided to reduce the bias while the trial is on-going. This group will discuss strategies for handling and reporting data during an open-label trial and the challenges of implementing such strategies. Question 1) Should efforts be made to blind the database? Should the teams running the day-to-day study have access to the raw data? Are there certain fields that normally would be collected (e.g., treatment arm, PK) on the CRF that should not be? Question 2) Who should be able to look at data by treatment group? Question 3) Should the Sponsor be able to look at data pooled across treatment group, but without treatment identification (e.g. Treatment A vs. Treatment B)?