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March 15, 2023

Discuss the use of Data Monitoring Boards in COVID Vaccine and Treatment Trials. #2 How should placebos be used in cancer studies? Are there reasons not to use placebos in cancer trials? #3

#1 Discuss the use of Data Monitoring Boards in COVID Vaccine and Treatment Trials.
#2 How should placebos be used in cancer studies? Are there reasons not to use placebos in cancer trials?
#3 Hexamethonium and Ellen Roche
What were the objectives of this trial?
What population was studied?
What methods were used?
What went wrong in this trial that led to an FDA audit?
What did the FDA auditor find upon their review?
How do you think cases like could be prevented in the future?
#4 What are the issues that could arise when a research protocol is approved by an IRB, but the investigator finds out afterwards that:
a subject is not complying with the protocol requirement?
the investigational agent has unexpected toxicities?
the proposed treatment regimen is not effective?please alsoprovide references

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