Ben Vaughn

Chief Strategist, Biostatistics & Protocol Design

Ben Vaughn

Chief Strategist, Biostatistics & Protocol Design

A proven leader in the industry for more than 20 years, Mr. Ben Vaughn serves as Rho’s Chief Strategist for Biostatistics and Protocol Design. In this role, he utilizes his extensive expertise to guide sponsors through marketing applications, regulatory interactions, and the design and analysis of analgesia trials.

Mr. Vaughn has supported over 50 pain trials, over 30 marketing applications, and 5 FDA advisory committee meetings (both back room and bullpen) over the course of his career. In the past year alone, he has had speaking roles in 12 FDA Type A, B, and C meetings.

His experience spans many therapeutic areas with emphasis on abuse liability trials, substance use disorders, as well as other psychiatric disorders and rare disease (orphan) products.

Mr. Vaughn earned both his bachelor’s and master’s degrees in Biostatistics from UNC-Chapel Hill.

Why Neurology and Analgesia?

“Neurology, and specifically pain-related clinical trials, is a fascinating area of research for me due to the obstacles that are presented. The outcomes are highly subjective and prone to influence by a number of factors completely unrelated to the investigational product being tested. Missing data cannot be ignored and novel analysis approaches are needed to evaluate their influence on trial outcomes. Addressing these concerns to the agency’s satisfaction is challenging but rewarding work.”

This is what drives Ben:

“Opioids have a place in the treatment of pain, but our understanding of their roles and risks has shifted over the course of my career. I am passionate about both ensuring their appropriate availability to patients that require them and finding products that can replace opioids. In the meantime, I am an ardent supporter of research to better understand treatment of substance use disorders and the role of prescription opioids in leading to such disorders, as well as the promotion of wide availability of medication assisted therapy and naloxone.”


Content by Ben Vaughn

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Webinar

Challenges with Fast Enrolling Post-Operative Acute Pain Studies

There are a lot of resources on how to deal with slow enrolling studies, but what about challenges with studies that enroll very quickly?  Enrollment can be very fast for post-operative acute pain studies which brings with it unique challenges in study execution. 

Blog Post

Maintaining Trial Integrity During COVID-19: Some Statistical Rules of Thumb

The COVID-19 pandemic is having a substantial impact on many ongoing clinical studies in all phases of product development. Numerous difficult decisions are being made and steps are actively being taken to ensure the safe execution, or future resumption, of ongoing studies. While patient safety is paramount and should drive all study conduct related decisions, many of these decisions can impact the interpretability of estimates of efficacy at study conclusion.