Congressionally Directed Medical Research Programs -- Orthotics and Prosthetics Outcomes Research Program -- Clinical Trial Award

Funding Agency:
Department of Defense

The FY20 OPORP CTA is intended to support the implementation of clinical trials with the potential to have a significant impact on improving the health and well-being of Service members, Veterans, and other individuals with limb loss and/or limb impairment. This award mechanism supports clinical trials that evaluate orthoses and/or prostheses using patient-centric outcomes for the purpose of generating clinically useful evidence to enhance and optimize patient outcomes. Proposed projects may range from small proof-of-concept trials to demonstrate feasibility or inform the design of more advanced trials, through large-scale trials in relevant patient populations. Alternate research designs (e.g., pragmatic and practice-based evidence trials) that provide evidence for adoption of tested orthotic and/or prosthetic devices in real-world clinical practice and inform clinical or policy decisions are particularly encouraged.

The FY20 OPORP CTA offers funding for two Funding Levels (Refer to Section II.D.5, Funding Restrictions). Only one Funding Level category may be chosen per application and the choice of application category is at the discretion of the applicant. The following are generalized descriptions of the scope of research appropriate for each Funding Level:

• Funding Level 1 supports pilot and early stage clinical trials, which are exploratory and involve limited human exposure (e.g., small sample size), with the potential to make significant advancements toward clinical translation. Preliminary data are encouraged but not required for this Funding Level.

• Funding Level 2 supports clinical trials with the potential to make significant advancement toward clinical translation. Proposed projects may include large-scale trials that, if successful, will produce high-quality outcomes that provide strong support for evidencebased practice and/or have the potential to drive changes in clinical practice. Preliminary data relevant to the proposed clinical trial are required.

Deadlines:

• Required Pre-Application Deadline: July 15, 2020
• Application Submission Deadline: July 29, 2020

Agency Website

Areas of Interest

Applications to the FY20 OPORP Clinical Trial Award (CTA) must address at least one of the Focus Areas listed below. Selection of the appropriate primary Focus Area is the responsibility of the applicant. This mechanism supports novel and innovative orthotics and prosthetics outcomes research, including development and employment of new approaches and tools for measuring outcomes. Research that involves developing or enhancing orthotic or prosthetic devices is not allowed.

Orthoses or Prostheses Form: Optimize patient outcomes through the analysis and characterization of variables related to the form of currently available clinical options such as device size, shape, material, and/or configurations.

Orthoses or Prostheses Fit: Optimize patient outcomes related to human-device interface through the analysis of variables in currently available clinical options that facilitate fit-related metrics such as comfort and/or usability.

Orthoses or Prostheses Function: Optimize patient outcomes through the analysis of variables related to currently available device function such as device control, sensors, and passive or active response with respect to activities of daily living and other real-world activities.

Eligibility Requirements

Independent investigators at all academic levels (or equivalent) may be named by the organization as the PI on the application. There are no limitations on the number of applications for which an investigator may be named as a PI. An eligible PI, regardless of ethnicity, nationality, or citizenship status, must be employed by, or affiliated with, an eligible organization.

Amount Description

The anticipated total costs budgeted for the entire period of performance for an FY20 OPORP CTA award will not exceed $350,000 (Funding Level 1) or $4M (Funding Level 2). Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

Funding Type

Grant

Eligibility

Faculty
Junior Faculty
Medical Fellow/Resident
Post Doctoral Fellows

Category

Interdisciplinary
Medical
Medical - Clinical Science

External Deadline

July 15, 2020