Too good to be true ??
Re the excellent posts by gernee20 ( 120461 ) and nidan7500 (120411 ) , all members on this board need to read the FULL text of Dr. Gottlieb's recent speech ( 9/11/17 ) to the Regulatory Affairs Professionals Society 2017 Regulatory Conference . Several comments have been referenced recently by Talon38 , however , many additional statements by Dr. Gottlieb seem to provide a solid reason for the recent quiet period by Anavex and the "delay " in the initiation of the planned trials .
Some quotes from the speech : " FDA continues to advance the use of new tools and clinical trial designs . For example , we are seeing wider use of adaptive approaches , which allow scientists to enrich trials for patient characteristics that correlate with benefits , or that help predict which patients are least likely suffer a certain side effect . "
" As part of these approaches , we're seeing more use of combined-phase studies , what's referred to as seamless trials . Instead of conducting the usual three phases of study , seamless trials encompass one adaptive study where the phases are separated by interim looks . "
" Seamless designs are particularly advantageous for drugs that work in a variety of diseases ,allowing rapid evaluation of the drug and potential approval under our accelerated approval pathway . These new approaches are also highly consistent with the goals of the 21st Century Cures Act .. "
" This approach is well suited to the kinds of drugs that are being developed now , where drugs intervene on common elements found across multiple kinds of disease states . "
" We're also advancing the use of ' Master Protocols ' to enable more coordinated ways to use the same trial structure to evaluate treatments in more than one subtype of a disease or type of patient .
This approach is particularly relevant when it comes to targeted drugs . These are drugs that may intervene on markers that are relevant across many different disease subtypes . We may, for example , want to evaluate these different targets simultaneously , as part of one large study . this could give us a better way to understand the comparative benefits of a drug across different settings . to enable these master protocols , it's often important to do molecular patient screening ."
" The Agency also needs to engage in more communication between sponsors , investigators , IRBs , and other stakeholders involved in the development program . This is not a ' business as usual ' approach . It may require a much more iterative process , with greater communication between alll of the stakeholders involved in the clinical trial processes . "
Hmmm ! Working closely with the FDA , Anavex may have the perfect ground - breaking candidate(s)
to test/ implement these new trial procedures .
I , for one , am willing to trust and wait ! GLTA !
AI
