Blog

We are so pleased to recognize the following milestones for members of our faculty and staff:

The FDA’s Center for Drug Evaluation and Research (CDER) has appointed Dr. Frank Harrell, professor of biostatistics at Vanderbilt University Medical Center, as a senior biostatistics advisor to the Office of the Center Director under the Intergovernmental Personnel Act (IPA) Mobility Program. CDER’s mission is to protect and promote public health by helping to ensure that human drugs are safe and effective for their intended use, meet established quality standards, and available to patients.

Under this appointment, Harrell will serve as a senior advisor to CDER on innovative and novel models for biostatistical analysis to facilitate the regulatory drug review in therapeutic areas with underserved populations or unmet medical needs. Harrell will advise the center on advanced approaches to drug regulatory pathways, optimization of regulatory science models, and complex statistical analysis methodologies and clinical trial designs.

The IPA Mobility Program provides for the temporary assignment of personnel between the federal government and state and local governments, colleges and universities, Indian tribal governments, federally funded research and development centers, and other eligible organizations. The program is a critical tool that allows federal agencies to access academicians or clinical experts on a part-time basis to bolster existing or new initiatives.

Harrell previously served as an advisor to the FDA CDER Office of Biostatistics from 2016 to 2020 and has been a long-time consultant to the FDA. "I am excited to serve in this important role at the request of the CDER director as part of my VUMC appointment, and look forward to contributing to making clinical trials more efficient and flexible, as well as to fostering development of statistical methods to analyze new types of patient outcomes in therapeutic clinical trials. My last two years of working with my Vanderbilt biostatistics and VICTR colleagues on the design and analysis of many high-profile Vanderbilt-led COVID-19 clinical trials has given me experience and ideas that I plan to put into use at FDA."

The May 2022 issue of our department newsletter is now available. We have upcoming events, incoming faculty, and recent honors to celebrate! 

Here are new and updated details about the upcoming Vanderbilt Symposium on Implementation Research in the Learning Health System. 

The planning committee includes professor Chris Lindsell and research assistant professor Cheryl L. Gatto.

Symposium registration: https://redcap.link/IRLHSregistration2022

Abstract submission for poster reception: https://redcap.link/IRLHSpostersubmission2022

Project proposal submission for workshop: https://redcap.link/IRLHSworkshopsubmission2022 

Spring has arrived in the Northern Hemisphere. To quote the poet Tennyson, "In the Spring a livelier iris changes on the burnish'd dove." (The state flower of Tennessee is the iris.)

Spring is also a great time to set new self-care goals. The Department of Biostatistics has a long-standing relationship with Vanderbilt's Health & Wellness initiative. Senior associate Dan Byrne helped create the award-winning Go for the Gold program in 2003, and with biostatistician Ryan Moore provides support for "The Healthy Pulse," a feature that appears on the back page of each issue of Connection, which is mailed to all Vanderbilt employees. 

Lead biostatistician Samuel Nwosu was featured in the March 17 issue of the ACTIV-6 Site Newsletter, and application developer Jubilee Tan in the March 4 edition. The interviews are republished here with permission of the Duke Clinical Research Institute.

Data Coordinating Center Spotlights

Samuel Nwosu

What is your role on ACTIV-6? 

Provide assistance with data management, create trial summary reports, perform data validations, and help with implementing the trial's interim analyses.

What activities or hobbies do you enjoy outside of work? 

I enjoy spending time with my family, a good jog, and the occasional adventurous/extreme activity.

Why do you think ACTIV-6 is important? 

This trial is at the forefront to help mitigate the spread of COVID-19 and provide a pathway to ending this global pandemic.

What drives and motivates you about working on the ACTIV-6 study? 

Knowing that the work I do is part of a bigger community to assist in the fight against COVID-19. Hopefully my effort within the ACTIV-6 study will help everyone get back to some sense of normalcy

Jubilee Tan

What is your role on ACTIV-6?

I maintain and upgrade automated information systems among four roles: participants, pharmacy, the call center, and biometric analysts.

What activities or hobbies do you enjoy outside of work?

When I get off work, I usually spend time with family, watch movies, and fix some issues in open source community.

Why do you think ACTIV-6 is important?

Since COVID changed our lives two years ago, many families may have faced a very big change, not only the loss of life, but also social distancing and economic shock. This project is an opportunity to turn things around so that people can go back to life before the pandemic.

What drives and motivates you about working on the ACTIV-6 study?

This project is about helping people fight COVID, and I feel very motivated every time I think about this work that could lead to an earlier end to the pandemic.