Anavex Life Sciences Corp (AVXL)

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http://raps.org/Regulatory-Focus/News/2017/07/07/28050/FDA-Officials-Master-Protocols-Needed-for-Precision-Medicine/?utm_source=Email&utm_medium=Informz&utm_campaign=Informz%2DEmails

FDA on new Master trials protocol..(sound familiar?)

In an article published Thursday in the New England Journal of Medicine, two top officials from the US Food and Drug Administration (FDA) say that "master protocols" for studies involving multiple drugs or multiple diseases (or both) simultaneously are needed to efficiently generate evidence for precision medicines.
"The standard approach to generating this evidence—a series of clinical trials, each investigating one or two interventions in a single disease—has become ever more expensive and challenging to execute. As a result, important clinical questions go unanswered," write Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) and Lisa LaVange, director of Office of Biostatistics within CDER.
Instead, the two argue that well-designed master protocols that look at multiple therapies in a single disease, a single therapy in multiple diseases, or multiple therapies across multiple diseases or disease subtypes, can provide answers more quickly and efficiently than traditional "stand-alone" clinical trials.
"If designed correctly, master protocols can last many years, even decades, with innovations from the laboratory translating quickly to clinical evaluation. As the targets for new drugs become more and more precise, there is no alternative but to move forward with these coordinated research efforts," Woodcock and LaVange write.