Increasingly, sponsors are turning to experts who have “been there, done that” to help them develop protocols for their CNS trials. In this wide-ranging interview, Sofija Jovic, PhD, MBA, of WCG MedAvanteProPhase, explains why this is the case. She also discusses, among other topics, how clinical trial metrics haven’t always kept pace with scientific innovation.
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If sponsors want to apply the same scientific rigor to the evaluation of medical devices as applied to pharmaceutical or biotech agents, they should consider independent endpoint adjudication.
This report summarizes a recent Tufts CSDD analysis of 509 drugs and biologics that received FDA approval from 2000 to 2017.
Industry trends show that a major contributor to trial failure is the increased rate of placebo response.Watch this webinar to learn how to increase the chances of trial success in an uncertain world.
It is important to understand patient perspectives and to anticipate how subjects in research studies may be impacted by the presence of digital tools, devices, and mobile health applications
Rates of placebo response across multiple therapeutic areas are now historically high. This article addresses 3 commonly shared ideas that researchers have about placebo response.