AI
Thursday, October 13, 2022 6:49:37 AM
"FDA clearly understands the issues with confounding"
You are correct the FDA does understand the issues
ATLnsider
@ATLnsider
FDA agrees that if there’s a Phase 3 clinical trial like $NWBO #DCVax, that allows control (placebo) patients in the trial to crossover to the treatment drug being studied, then an External Control Arm can be used to help augment & interpret the results: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165904723
"In oncology, there are clinical settings and scenarious where randomization may be difficult or not feasible (e.g., rare diseases, small patient population, loss of equipoise, availability of the investigation agent outside of the clinical trial). Additionally, patients with serious, life threatening diseases may often seek trials where the likelihood of receiving the investigational agent is high (e.g., single arm studies, designs that allow treatment crossover). However, these scenarious (described in Table 3) may make interpreting the clinical trial results difficult or could introduce uncertainty in the results. The use of external controls in clinical studies represents an opportunity to potentially reduce the number of patients in the control arm, enhance data obtained from clinical trials, and improve the interpretability of results"
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165904723
https://www.focr.org/sites/default/files/Panel-1_External_Control_Arms2019AM.pdf
You are correct the FDA does understand the issues
ATLnsider
@ATLnsider
FDA agrees that if there’s a Phase 3 clinical trial like $NWBO #DCVax, that allows control (placebo) patients in the trial to crossover to the treatment drug being studied, then an External Control Arm can be used to help augment & interpret the results: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165904723
"In oncology, there are clinical settings and scenarious where randomization may be difficult or not feasible (e.g., rare diseases, small patient population, loss of equipoise, availability of the investigation agent outside of the clinical trial). Additionally, patients with serious, life threatening diseases may often seek trials where the likelihood of receiving the investigational agent is high (e.g., single arm studies, designs that allow treatment crossover). However, these scenarious (described in Table 3) may make interpreting the clinical trial results difficult or could introduce uncertainty in the results. The use of external controls in clinical studies represents an opportunity to potentially reduce the number of patients in the control arm, enhance data obtained from clinical trials, and improve the interpretability of results"
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165904723
https://www.focr.org/sites/default/files/Panel-1_External_Control_Arms2019AM.pdf
FDA agrees that if there’s a Phase 3 clinical trial like $NWBO #DCVax, that allows control (placebo) patients in the trial to crossover to the treatment drug being studied, then an External Control Arm can be used to help augment & interpret the results: https://t.co/1f4RFQvRIH pic.twitter.com/vcaCFCt2Qf
— ATLnsider (@ATLnsider) September 14, 2021
