NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44)

This Funding Opportunity Announcement (FOA) invites Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials.

A clinical trial is defined by NIH as: “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." - See more at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html#sthash.W5hQ9GMA.dpuf 

This program provides support for milestone-driven, hypothesis-driven clinical trials related to the research mission of the NIAID that address a research area considered high priority by the Institute. Applicants seeking only SBIR Phase II support must have received SBIR Phase I support that is appropriate and relevant (e.g., pre-clinical studies, planning activities, etc.) to this FOA.

Although clinical trials not considered high-risk (see NOT-AI-10-024) may be proposed, this program encourages high-risk clinical studies.  High-risk does not imply human subject or patient risk, but rather defines a study that contains one or more of the following unique attributes: involves non-routine interventions, administration of an unlicensed product, or administration of a licensed product for an unapproved indication.  Additionally, mechanistic studies are encouraged and can be proposed under this program.  Applicants may not propose more than one clinical trial per application.

The NIAID has a robust infrastructure for conducting clinical studies that includes independently managed resources provided through grants and contracts, as well as resources that are integrated within existing NIAID-supported clinical trial networks.  Proposed clinical trials may use NIAID’s independent infrastructure for clinical studies; however, support will not be provided for studies that propose to use dedicated resources that are part of a NIAID-supported clinical trial network.

Over the past three years, NIAID committed over $4 billion to clinical research, of which $2 billion was devoted to clinical trials. Clinical trials are one research strategy NIAID uses to improve the understanding of the clinical mechanisms of infectious, immunologic, and allergic diseases or to improve prevention, diagnosis, and treatment. For additional information about the mission, strategic plan, and research interests of the NIAID, applicants are encouraged to consult the NIAID web site http://www3.niaid.nih.gov/about/whoWeAre/planningPriorities/.

Clinical Trial Infrastructure

Historically, NIAID has supported a wide variety of clinical research activities through a clinical trial infrastructure funded through cooperative agreements, solicited under NIAID Funding Opportunity Announcements (FOAs), and contracts, solicited under NIAID Requests for Proposals (RFPs). This infrastructure focuses on high-priority disease research areas. Examples include the HIV/AIDS Clinical Trial Networks supported by the Division of AIDS (http://www.niaid.nih.gov/about/organization/daids/Networks/Pages/daidsnetworks.aspx), the Division of Microbiology and Infectious Diseases Clinical Trials Programs and Networks (http://www.niaid.nih.gov/about/organization/dmid/researchers/clinical/Pages/leadership.aspx ), and the Immune Tolerance Network supported by the Division of Allergy, Immunology and Transplantation (http://www.immunetolerance.org/).

NIAID’s clinical research infrastructure includes coordinating centers, statistical units, data centers, central laboratories, clinical centers, and other specialized resources. For additional information on DMID supported clinical trials refer to the DMID Good Clinical Practice Resource Guide    (https://www.dmidcroms.com/Shared%20Documents/Good%20Clinical%20Practice%20Resource%20Guide.pdf .  For additional information on DAIDs supported clinical trials refer to the Division of AIDS (DAIDS) Clinical Research Policies and Standard Procedures Documents:  http://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Pages/Default.aspx .  For additional information on DAIT Clinical Research Policies and Documents: http://www.niaid.nih.gov/LabsAndResources/resources/DAITClinRsrch/Pages/default.aspx.

Investigator-Initiated Clinical Trials

Although clinical trial infrastructure is crucial to furthering the Institute’s research, the NIAID recognizes that additional means to support clinical research may be important to advancing its research mission.  Therefore, the NIAID has established the investigator-initiated clinical trial program for clinical trials that cannot or will not be conducted through existing NIAID-supported clinical trial networks.  This FOA supports applications that propose clinical trials to be conducted outside of NIAID’s existing clinical trial infrastructure; support will not be provided for clinical trials that propose to use dedicated resources that are part of a NIAID-supported clinical trial network.

This FOA provides a unique and focused opportunity for small business concerns (SBCs) interested in conducting clinical trials.  If a clinical trial is ready for implementation, and readiness is adequately supported by appropriate documentation, SBCs are encouraged to submit applications to this FOA.

For additional information about NIAID’s investigator-initiated clinical trial program, see http://www.niaid.nih.gov/researchfunding/sci/human/pages/iict.aspx. 

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-enrollment 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:

• 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 further information, please see the following FAQ site: http://www.niaid.nih.gov/researchfunding/qa/Pages/PAR-16-SBIR.aspx

See Section VIII. Other Information for award authorities and regulations.