I-Corps: Clinical trial safety

Information

  • NSF Award
  • 2302093
Owner
  • Award Id
    2302093
  • Award Effective Date
    5/1/2023 - a year ago
  • Award Expiration Date
    10/31/2024 - 4 months from now
  • Award Amount
    $ 50,000.00
  • Award Instrument
    Standard Grant

I-Corps: Clinical trial safety

The broader impact/commercial potential of this I-Corps project is the development of an innovation for community providers providing direct access to clinical trial safety information when developing a plan of care for a trial participant outside of the research setting, including which medicines and treatments to explicitly avoid. Approximately 1 in 50 children and hundreds of adults enrolled in clinical trials (particularly in oncology) experience a fatal drug interaction, largely attributed to lack of trial details at time of clinical encounter. This innovation has the potential to improve the well-being of individuals by support and inform current policy initiatives aiming to expand availability of clinical trial opportunities for adult and pediatric patients, such as by easing travel burdens associated with clinical trial visits and procedures. As a mobile, bridging technology that can span any distance and be accessed by any provider, this innovation can bolster expanded clinical trial access for individuals and communities in rural settings, who may otherwise be unable to participate (or risk injury by accessing care in an uninformed setting) and will thus broaden participation of underrepresented minorities in science. <br/><br/>This I-Corps project is based on the development of a new product that addresses the challenges of clinical trial management by leveraging wearable technology and embedded software to provide real-time safety information for participants. This use-inspired solution represents the <br/>convergence of disparate fields, including engineering (human factors, ergonomics), computer science (user experience, human-centered computing), and nursing models of patient care (clinical outcomes). Preliminary data demonstrate that clinical nurses have a high knowledge deficit related to the unique care needs of clinical trial participants and do not screen for such needs during assessments. This innovation catalyzes opportunities for open information exchange that will broaden healthcare providers’ knowledge of drug testing safety and improve clinical care outcomes. Through the integration of trial safety information (drug interactions with standard of care treatments, side effect profiles, research team contact information) and related increase in trial participant retention, this product will accelerate the scientific understanding needed to develop novel therapeutics while positively altering the pharmaceutical industry research paradigm related to equitable, inclusive, and accessible safety management.<br/><br/>This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

  • Program Officer
    Ruth Shumanrshuman@nsf.gov7032922160
  • Min Amd Letter Date
    4/21/2023 - a year ago
  • Max Amd Letter Date
    4/21/2023 - a year ago
  • ARRA Amount

Institutions

  • Name
    Montana State University
  • City
    BOZEMAN
  • State
    MT
  • Country
    United States
  • Address
    216 MONTANA HALL
  • Postal Code
    59717
  • Phone Number
    4069942381

Investigators

  • First Name
    Elizabeth
  • Last Name
    Johnson
  • Email Address
    elizabeth.johnson37@montana.edu
  • Start Date
    4/21/2023 12:00:00 AM

Program Element

  • Text
    I-Corps
  • Code
    8023

Program Reference

  • Text
    Health Care Enterprise Systems
  • Code
    8023