Vol. 14 | January 2023 3 minute read

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Improving Clinical Trial Activation Time

New initiatives led by the Office of Clinical Research (OCR) seek to reduce the time it takes to open a clinical trial at UT Southwestern from over 120 days to less than 90 days, and 60 days or less for high-priority studies. 


OCR is collaborating with Sponsored Programs Administration, the Human Research Protection Program, and the Office of Quality, Safety, and Outcomes Education to deconstruct the steps involved in clinical trial activation at UTSW and improve on current processing times. 


Additionally, OCR is recruiting a new project specialist to serve as a liaison between study sponsors, departments, and investigators during the study startup process, detect and remove bottlenecks, and rapidly activate clinical trials. The goal is to shorten the time between trial activation and first-subject recruitment by lining up potential participants to introduce and consent to the study as soon as it is active.  


These initiatives will expand UTSW’s capacity to become a top destination for sponsors to test novel therapeutic ideas and inventions. 

UTSW Biostatistics and Data Science Core

A new Biostatistics and Data Science Core (BDSC) will support and augment our institution’s capacity for high-quality, efficient, quantitative, and data science services at UTSW.  

 

With startup support from the Dean’s Office, the new core will hire multiple quantitative and data science specialists while also working to better coordinate existing resources across the campus.

 

The new BDSC team will aim to support our institution’s growing federal and industry-funded clinical research projects. Services can be requested in the form of fee-based projects or by contracting a percentage of the effort of a full time employee (FTE) for a set period of time.   


For more information, contact Biostatistics and Data Science Core Director Donghan “Mo” Yang, Ph.D., at BDSC@utsouthwestern.edu.

BDSC Service Types: 



-- Coordination, study design, and grant application assistance 


-- Study design and sample size estimates



-- Database programming and cleaning in preparation for analysis-ready format 

 

-- Data analysis, statistical modeling, and machine learning

 

-- Tables and figures design for grant applications and papers.

Human Research Protection Program

Receives High Marks During Reaccreditation

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has awarded UT Southwestern’s Human Research Protection Program (HRPP) full reaccreditation for five years. The accrediting body noted the translation process our HRPP has established - which alleviates the burden on study teams and increases access to translated materials – as a best practice peers should follow. It also acknowledged areas where our organization excelled, including: 


  • The availability of robust tools to identify, manage, and minimize conflicts of interest of research teams.  
  • Demonstrated institutional commitment to providing resources and tools to educate investigators on HRPP requirements.  
  • Engaged nonscientist IRB members to promote the voice of the research participants in our studies. 


Congratulations to our HRPP team for their dedication to this 18-month reaccreditation process under the capable leadership of Rhonda Oilepo, Assistant Vice President for Human Research Administration.  

Important Dates and Upcoming Events

Successfully Obtaining an R (SOAR) Grant Program

The SOAR grantsmanship program provides junior faculty conducting basic, translational, or clinical

research the opportunity to work with a coach to craft a fundable proposal.


Clinical and Translational Science Forum

This interactive forum provides an opportunity for trainees to meet with established investigators in clinical and translational research to share their ideas and experiences.


  • Thursday, Jan. 19, at 12:15 p.m., Lin Guo presents "Oscillatory Dynamics of Verbal Working Memory Performance in Healthy Aging." Register to attend. 


  • Thursday, Jan. 26, at 12:15 p.m., Sarguru Subash, B.VSc., Ph.D., presents "A Minipig Model of Urinary Tract Infection." Register to attend. 

Community Engagement Grand Rounds

Linda B. Cottler, Ph.D., M.P.H., FACE, presents "Sustaining Trustworthiness in Our Community Engagement Program." 


  • Tuesday, Jan. 24, at noon. Register to attend.

Didactic Session: Getting Started in Research at UTSW 

Monthly sessions on successful project development and the grant application process are part of the Clinical Researcher Catalyst (VPN required), a career development program for clinical researchers.


  • Tuesday, Jan. 31, at noon. "Practical Advice and Grants for Effective Collaborations." Register to attend.

Master of Public Health

Join the inaugural M.P.H. class of the Peter O’Donnell Jr. School of Public Health and gain the skills to identify, predict, and address wide-scale health problems and respond to public health emergencies.


Master of Science in Clinical Science

Designed for those who aim to accelerate their clinical and translational research careers, the Master of Science in Clinical Science program includes courses on clinical research design, methods and biostatistics, leadership, and scientific writing.  

 

Staying Connected, Informed, and Involved 

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