Clinical Trials

As far back as the implantation of the first battery-powered pacemaker in 1958, the University of Minnesota has been a leader in clinical trials. Now, the Clinical and Translational Science Institute (CTSI) consolidates UMN resources for clinical trials.
 

Clinical and Translational Science Institute:

CTSI will help your company plan, execute, and manage large or small scale clinical trials to prepare your product for FDA approval and commercial launch. The Institute is designed to streamline clinical resources to researchers.

Support for clinical and translational research phases:

CTSI offers translational research services from start to finish of the clinical research process.

  • Study planning and design
  • Identifying funding opportunities
  • Budget development
  • Protocol development
  • Regulatory guidance and support
  • Recruitment
  • Staffing and implementation
  • Data collection and management
  • Statistical analysis
  • Closeout

Consultations:

CTSI offers consultations about these topics and others.

  • Biostatistics
  • Community-engaged research
  • Early-stage translational research
  • Informatics
  • Participant recruitment
  • Regulatory topics

For-fee services:

CTSI facilitates access to University staff, facilities, and procedures with hourly and per-unit rates.

  • Clinical unit staff and space
  • Biostatistical support
  • Specialized / equipment-intensive procedures
  • Specimen processing and storage
  • Nutrition

Contact Dwight Nelson for more information about connecting with CTSI.

 

Featured Researcher: David Darrow

David Darrow - headshot

David Darrow, MD, MPH, pioneered a method of testing a novel spinal cord stimulation (SCS) technology from Abbott through a clinical trial at the University of Minnesota. Dr. Darrow connected with Abbott upon learning of an SCS technology that could make a difference for his patients. His trial collects data via home-based participation to optimize the programming of the stimulator.

The stimulator can apply 4.1 million possible unique settings on each of eight channels to treat patients, and researchers need to identify which of the settings has preferred outcomes for patients. Darrow has streamlined the process of sorting the possible settings by using an app that enables patients to test settings from home.

This app walks patients through a list of settings indicated by their physician. With each setting, they perform rehab actions and their phone or tablet’s accelerometer records their motions. Trial patients can generate useful data throughout the month with only one office visit.
As more patients participate in the Series I clinical study that Dr. Darrow is undertaking, they will build a dataset to make this Abbott technology more effective at treating patients. By being creative in the ways you use what already exists, Dr. Darrow believes you can benefit patients in new and meaningful ways.

You can watch Dr. Darrow's presentation about the technology here, or check the current progress of the study here.