Notice of Clarification for PAR-18-632 NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)

Notice Number: NOT-AI-18-031

Key Dates
Release Date: May 16, 2018

Related Announcements
PAR-18-632

Issued by
National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The purpose of this Notice is to clarify the scope for PAR-18-632, NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required).
 

Part 2. Section I. Funding Opportunity Description


Current Language:
 

Scope

The NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) program supports implementation of clinical trials from small business concerns (SBCs) that propose clinical trials in research areas that are well matched with the mission and goals of the NIAID.
 
The proposed clinical trial should be hypothesis-driven and milestone-driven. 
 
All clinical trial planning activities must be completed prior to the time of application submission and all requested documentation needs to be provided for an application to be considered complete for a Phase II award.
 
Investigators are referred to NIAID's Clinical Research Toolkit website for protocol templates and guidance, clinical research resources, and links to program divisions. Investigators are strongly encouraged to contact the NIAID Scientific/Research Contact(s) for information regarding division-specific clinical research policies and procedures.
 
For the purposes of this FOA, implementation support is defined as support for the conduct, completion, and analysis of a clinical trial, including activities related to the conduct of the clinical trial, which include but are not limited to the following:
 
  • training of study personnel;
  • enrollment and recruitment of study subjects;
  • investigational product costs;
  • data collection, management and quality control;
  • laboratory work and data analyses;
  • study management and oversight;
  • establishment of committees to manage the complexity of the trial;
  • preparation of the final study report; and other related post-trial activities
  • Regulatory activities and site monitoring can be covered if required.

Mechanistic studies are also encouraged and can be proposed under this program.

Milestones
 
Delineation of milestones is a key characteristic of awards made in support of the NIAID's investigator-initiated clinical trial program, including this NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) FOA.  A milestone is defined as a scheduled event in the project timeline, signifying the completion of a major project stage or activity.
 
Proposed clinical trial milestones provide a clear delineation of the criteria used to identify completed activities, but also provide for contingency plans to accommodate anticipated impediments that could require a revision in the timeline.  Recognizing and indicating potential problems and obstacles are important aspects in identifying and discussing alternative approaches.  The milestones will undergo peer review and will be incorporated into the terms of award.
 
The following research areas are inappropriate and will not be supported by this FOA (except Fast-Track applications):
 
Clinical trial planning tasks, such as:
 
  • Development of study design;
  • Identification of collaborators and enrollment sites;
  • Development of the clinical protocol and informed consent form;
  • Development of the statistical analysis plan;
  • Development of the data management plan;
  • Development of the Investigator's brochure or equivalent;
  • clinical trials that fall outside the mission and goals of the NIAID;
  • clinical trials that propose to use dedicated resources that are part of an existing NIAID-supported clinical trial network; or
  • more than one proposed clinical trial per application (applicants should not propose more than one clinical trial within an application).

The NIAID reserves the right to specify: 1) whether an IND (Investigational New Drug)/IDE (Investigational Device Exemption) application should be submitted to an appropriate regulatory agency; 2) the entity (NIAID, primary awardee, etc.) who will hold the IND/IDE; and 3) the requirements for the establishment of a DSMB (Data Safety Monitoring Board)/SMC (Safety Monitoring Committee). Applicants are encouraged to discuss those decisions and requirements with NIAID prior to submission of the application
 
All research and development activities associated with awards made under this NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) FOA must be performed within the United States.
 
For more information, please see the Investigator-Initiated Clinical Trial Questions and Answers at:  https://www.niaid.nih.gov/grants-contracts/investigator-initiated-clinical-trials-faqs.
 
See Section VIII. Other Information for award authorities and regulations.
 

Modified Language:

 

Scope

  The NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) program supports implementation of clinical trials from small business concerns (SBCs) that propose clinical trials in research areas that are well matched with the mission and goals of the NIAID.
 
The proposed clinical trial should be hypothesis-driven and milestone-driven. 
 
Phase II/IIB Applications: All clinical trial planning activities must be completed prior to the time of application submission and all requested documentation must be provided for an application to be considered complete for a Phase II/IIB award.
 
Fast-Track Applications: Clinical trial planning documentation should be provided if available at time of application submission. Applicants should describe how any outstanding clinical trial planning activities and incomplete documentation will be resolved during completion of Phase I Aims. If selected for funding, Phase II support will be contingent upon successful completion of clinical trial planning activities and meeting milestones. 
 
Investigators are referred to NIAID's Clinical Research Toolkit website for protocol templates and guidance, clinical research resources, and links to program divisions. Investigators are strongly encouraged to contact the NIAID Scientific/Research Contact(s) for information regarding division-specific clinical research policies and procedures.
 
For the purposes of this FOA, implementation support is defined as support for the conduct, completion, and analysis of a clinical trial, including activities related to the conduct of the clinical trial, which include but are not limited to the following:
 
  • training of study personnel;
  • enrollment and recruitment of study subjects;
  • investigational product costs;
  • data collection, management and quality control;
  • laboratory work and data analyses;
  • study management and oversight;
  • establishment of committees to manage the complexity of the trial;
  • preparation of the final study report; and other related post-trial activities
  • Regulatory activities and site monitoring can be covered if required.

Mechanistic studies are also encouraged and can be proposed under this program.

Milestones
 
Delineation of milestones is a key characteristic of awards made in support of the NIAID's investigator-initiated clinical trial program, including this NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) FOA.  A milestone is defined as a scheduled event in the project timeline, signifying the completion of a major project stage or activity.
 
Proposed clinical trial milestones provide a clear delineation of the criteria used to identify completed activities, but also provide for contingency plans to accommodate anticipated impediments that could require a revision in the timeline.  Recognizing and indicating potential problems and obstacles are important aspects in identifying and discussing alternative approaches.  The milestones will undergo peer review and will be incorporated into the terms of award.
 
Clinical trial planning tasks will not be supported by this FOA, except when included in the Phase I Aims of a Fast-Track application. Clinical trial planning includes tasks such as: 
 
  • Development of study design;
  • Identification of collaborators and enrollment sites;
  • Development of the clinical protocol and informed consent form;
  • Development of the statistical analysis plan;
  • Development of the data management plan;
  • Development of the Investigator's brochure or equivalent;

 The following are inappropriate and will not be supported by this FOA:
 
  • clinical trials that fall outside the mission and goals of the NIAID;
  • clinical trials that propose to use dedicated resources that are part of an existing NIAID-supported clinical trial network; or
  • more than one proposed clinical trial per application (applicants should not propose more than one clinical trial within an application).

The NIAID reserves the right to specify: 1) whether an IND (Investigational New Drug)/IDE (Investigational Device Exemption) application should be submitted to an appropriate regulatory agency; 2) the entity (NIAID, primary awardee, etc.) who will hold the IND/IDE; and 3) the requirements for the establishment of a DSMB (Data Safety Monitoring Board)/SMC (Safety Monitoring Committee). Applicants are encouraged to discuss those decisions and requirements with NIAID prior to submission of the application
 
All research and development activities associated with awards made under this NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) FOA must be performed within the United States.
 
For more information, please see the Investigator-Initiated Clinical Trial Questions and Answers at:  https://www.niaid.nih.gov/grants-contracts/investigator-initiated-clinical-trials-faqs.
 
See Section VIII. Other Information for award authorities and regulations.
 
All other aspects of this FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Natalia Kruchinin Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2919
Email: kruchininn@niaid.nih.gov