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Re: Jonjones325 post# 210975

Wednesday, 09/25/2019 12:11:07 AM

Wednesday, September 25, 2019 12:11:07 AM

Post# of 518929

As patients finish, can they look at and analyze the data? Or do they need to wait until the trial is completely finished to take a peak?



The DSMB gets a peek at the data while the study is ongoing but the company does not. That would risk influencing the study. The DSMB does not report the interim data to the company just whether the study should continue unmodified, with modifications or be stopped for safety (and if pre-specified, for efficacy). Once the last patient has their last visit and all data has been collected, the CRO makes sure all the data is reviewed, queries to the sites are created to clarify any issues, the sites respond and finally the database is locked and delivered to the statisticians. They scrub the data and analyze it and deliver the results to the sponsor/company.

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