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Jack Modell
Blog Post

Why Depression Studies So Often Fail: Don’t Blame “Placebo Response”

After careful review of internal and external data, as well as published explanations for high “placebo response rates” in clinical depression trials (much of which also applies to clinical trials in general), three factors emerged as being of particular importance because they are easily mitigated by proper trial design, thorough research staff training, and meticulous oversight of study conduct.

Blog Post

Practical Strategies to Simplify Patient Centricity: Part 3—Why Patient Centricity, Why Now?

This is the third in a series of blog posts on putting patient-centric principles into practice. Before diving into the practical ramifications of patient centricity, it helps to understand some of the factors responsible for the emergence of this trend. In this post, we examine a few of the driving forces behind patient centricity, and consider consequences for our industry.

patient-centricity-elephant
Blog Post

Practical Strategies to Simplify Patient Centricity: Part 1—Overview

This is the first in a series of blog posts on putting patient-centric principles into practice. How do you eat an elephant?  One bite at a time, right? Specifically, how do we eat the elephant of patient centricity?  We can employ simple, actionable, “bite-sized” strategies that will move us closer to a more patient-centric approach.

Blog Post

Key Takeaways from ACRP 2017

This week we attended the 2017 ACRP Annual Meeting in Seattle. Here are some of the key trends, themes, and ideas that we took away from this robust meeting. 

Heather Kopetski
Blog Post

FDA Guidance on Non-Inferiority Clinical Trials to Establish Effectiveness

In November 2016, the FDA released final guidance  on Non-Inferiority Clinical Trials to Establish Effectiveness providing researchers guidance on when to use non-inferiority trials to demonstrate effectiveness along with how to choose the non-inferiority margin, test the non-inferiority hypothesis, and provide interpretable results. This article provides background on a non-inferiority trial design along with assumptions and advantages and disadvantages of the trial design.

Blog Post

An Interactive Suite of Data Visualizations for Safety Monitoring

This is the fourth in a series of posts introducing open source tools Rho is developing and sharing online. To improve safety monitoring, we created a suite of interactive data monitoring tools we call the Safety Explorer. Safety Explorer can be configured to include a variety of charts specific to each study.