Notice Number: NOT-TR-18-016
Key Dates
Release Date: January 16, 2018
PAR-17-465
Issued by
National Center for Advancing Translational Sciences (NCATS)
Purpose
The purpose of this Notice is to update the Purpose, Award Budget and Research Strategy information for the Planning Portion (UH3) in the FOA, "Bench Testing Therapeutic/Indication Pairing Strategies (UG3/UH3)" (PAR-17-465) to allow support for feasibility studies in the UH3.
This change is effective beginning with the February 28, 2018 receipt date and all subsequent dates.
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Purpose
The language currently reads:
Once UG3 pre-clinical milestones have been met, the UH3 award may be made to support clinical trial planning: this includes complete planning, design, and preparation of the documentation necessary for implementation of Phase I and/or Phase II clinical trials for a new therapeutic use.
This language is revised to read:
Once UG3 pre-clinical milestones have been met, the UH3 award may be made to support clinical trial planning: this includes collection of feasibility data and complete planning, design, and preparation of the documentation necessary for implementation of Phase I and/or Phase II clinical trials for a new therapeutic use.
Part 2. Full Text of Announcement
Section II. Award Information
Award Budget
The language currently reads:
Application budgets need to reflect the actual needs of the proposed project but may not be greater than:
UG3: up to $200,000 direct costs/year
UH3: up to $100,000 direct costs.
This language is revised to read:
Application budgets need to reflect the actual needs of the proposed project but may not be greater than:
UG3: up to $200,000 direct costs/year
UH3: up to $225,000 direct costs.
Section IV. Application and Submission Information
2. Content and Form of Application Submission
Research Strategy
The language currently reads:
UH3
The trial planning period is intended for time and financial support to develop clinical trial documents and to fully design a clinical trial for projects that meet pre-clinical milestones. Applications must include the following:
- A description of how the planning period will be used and descriptions and timing of the activities to be carried out during the planning period, including participants in the planning process and their roles;
- Information about how the clinical trial documents will be developed; and a description of how the trial will be organized and managed, including the plans to identify and select additional collaborators, if applicable.
- Anticipated need for a trial, potential impact of the results of the trial, and how the trial will test overall hypothesis(es) proposed;
This language is revised to read:
UH3
The trial planning period is intended for time and financial support to collect feasibility data, to develop clinical trial documents and to fully design a clinical trial for projects that meet pre-clinical milestones. Applications must include the following:
- Describe the need for the clinical trial that is being planned;
- Discuss the potential impact of the results of the trial that is being planned;
- Give a brief description of the study population characteristics; and
- Provide an overview of how the trial will test the overall hypothesis(es) that will be tested.
The Research Strategy must also include: Plans for collecting feasibility data. This data collection should use existing datasets and resources (e.g. databases), whenever possible. Depending on the project, it may be helpful to assess feasibility using patient samples (e.g., estimate prevalence of a genotype that affects drug metabolism). In addition, demonstration of an appropriate and interested patient population may be demonstrated by interviews, surveys, focus groups or prior performance at the site. The feasibility data collection will provide the following types of information:
- Availability of individuals with the disease or condition being tested at the study site. Whether the distribution by age, sex/gender, race, and ethnicity is representative for the disease/condition being tested;
- Feasibility of inclusion/exclusion criteria;
- Based on existing literature and data, determine if drug-drug interactions exclude too many subjects with the condition for the experimental therapy to be feasible to use in the proposed study population;
- Estimate how many study sites will be needed to complete the study within a reasonable timeframe. For applications that will request funds from NCATS for subsequent clinical trials, the reference timeframe is one year for a Phase I clinical trial, two years for a Phase II clinical trial, three years for an adaptive designed clinical trial; or up to three years to demonstrate substantial evidence of efficacy in treating or preventing a rare disease or condition and to establish evidence of safety for that use in a rare or neglected disease population;
- A description of how the planning period will be used and descriptions and timing of the activities to be carried out during the planning period, including participants in the planning process and their roles; and
- Information about how the clinical trial documents will be developed; and a description of how the trial will be organized and managed, including the plans to identify and select additional collaborators, if applicable.
All other aspects of this FOA remain unchanged.
Inquiries
Please direct all inquiries to:
Bobbie Ann Mount, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0824
Email: bobbieann.mount@nih.gov
and Human Services (HHS)
