Newsletter - April 6, 2023
Disclose Possibility of Early Termination in Informed Consent: IRB
A clinical trial may terminate early for a number of reasons unrelated to the safety of the investigational product. A survey of informed consent documents found that most of them do not acknowledge the possibility of early termination of the trial and the potential direct or indirect consequences for the participants...Read More
Trial Does Not Meet the Primary Endpoint? No Worries, FDA Still Might Approve
About 10% of new drugs approved by the FDA between 2018-2021 failed their primary endpoints in one of more pivotal clinical trial but were still approved based on success in at least 1 other pivotal study, positive findings from secondary or exploratory end points in the pivotal study, or favorable post hoc analysis...Read More
Disclose Possibility of Early Termination in Informed Consent: IRB
A clinical trial may terminate early for a number of reasons unrelated to the safety of the investigational product. A survey of informed consent documents found that most of them do not acknowledge the possibility of early termination of the trial and the potential direct or indirect consequences for the participants...Read More
Trial Does Not Meet the Primary Endpoint? No Worries, FDA Still Might Approve
About 10% of new drugs approved by the FDA between 2018-2021 failed their primary endpoints in one of more pivotal clinical trial but were still approved based on success in at least 1 other pivotal study, positive findings from secondary or exploratory end points in the pivotal study, or favorable post hoc analysis...Read More
