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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Don't Do It Alone: The Need for Independent Insight and the Role of Outside Expert Committees
Creating Scientific Rigor in Medical Device Trials
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.
2018 Tufts CSDD IMPACT Report for CNS
This report summarizes a recent Tufts CSDD analysis of 509 drugs and biologics that received FDA approval from 2000 to 2017.
58:43Placebo Response in Clinical Trials: Approaches to Mitigation
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.
Addressing Suggestibility as a Psychological Phenomenon in Clinical Trials
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
Clinical Researcher: Myths and Realities of Placebo Response - A 21st Century Prescription
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.
