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I agree 100% flipper44. In fact, Dr. Ricard

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ATLnsider   Tuesday, 09/14/21 11:23:28 AM
Re: flipper44 post# 401798
Post # of 423984 
I agree 100% flipper44. In fact, Dr. Ricard Pazdur, Director of the FDA Oncology Center of Excellence, has said this, and this White Paper by Friends of Cancer Research (FOCR), explicitly states that an external control arm can be used, and should be used:

Quote:
To augment or replace a randomized control with patients who did not receive the experimental product so that the difference between arms is a more accurate estimate of the actual treatment effect


The FOCR Working Group that authored this White Paper included members from academia, biotech and pharmaceuticals companies, and biotech data analytic companies, and 3 members directly from the FDA Oncology Center of Excellence (OCE): Michael Menefee, Pallavi Mishra-Kalyani, and Bindu Kanapuru.

This is another reason why I believe that the FDA is the lead regulatory agency that is driving the DCVax-L regulatory approvals train by using Project Orbis to accelerate DCVax-L approvals in the US, UK, Canada, Germany and the rest of the EU, and also making DCVax-L a foundational part of the new standard of care (SOC) treatment for newly diagnosed and recurrent GBM patients worldwide.

https://www.focr.org/sites/default/files/Panel-1_External_Control_Arms2019AM.pdf





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