BTD represents a paradigm shift at the FDA

[sargasso]

Interesting study concerning the true nature and real benefits of a BTD. According to this study a BTD represents a” paradigm shift” at the FDA and involves “far more” than an increase in FDA oversight during the drug development process. Also note: “Essential to expediting BTD drugs is the elimination of the phase III trial in the accelerated approval component of drug registration. In its place is a hybrid phase I or II clinical trial…” -

“On the basis of the data presented here, BTD can be seen as a true paradigm shift in the FDA’s philosophy for the production of clinical evidence supporting drug efficacy in marketing applications. In fact, as noted earlier, the clinical trial structure supporting regulatory approval for BTD drugs is vastly different under the FDA Expedited Model. Although FDA guidance documents5 clearly state that the BTD pathway is strictly an administrative status and is not a true accelerated approval pathway, the data from this review support the concept that BTD designation provides far more than increased FDA administrative oversight during the development process. In point of fact, a drug meeting BTD standards may be developed on an abbreviated clinical trial pathway that is markedly different from that used by drugs attempting to reach registration by the standard, three-step, sequential method of clinical testing. Essential to expediting BTD drugs is the elimination of the phase III trial in the accelerated approval component of drug registration. In its place is a hybrid phase I or II clinical trial, carried out at a registrational standard of quality, that combines dose finding, dose confirmation, efficacy, and safety testing, all in the same clinical trial.

http://bit.ly/2jP8aPy

[biopearl]

Sargasso, this is (another one of your) great finds. Thanks for sharing. There is certainly a reasonable likelihood of BTD in R/R MF. bp