Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3)

PAR-16-300
Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3)
Department of Health and Human Services
National Institutes of Health

stem

Research Objectives

Proposed clinical trials may utilize a design anywhere along the continuum between explanatory and pragmatic. For this FOA, pragmatic trials are considered those that test an intervention under the usual clinical conditions in which it will be applied, while explanatory trials do so under more idealized circumstances. The trial design should be appropriate for the study question.

This CCC FOA runs in parallel with a companion FOA (PAR-16-301) that encourages applications for a collaborating Data Coordinating Center (DCC). Both a CCC application and a collaborating DCC application must be submitted on the same due date for consideration by NHLBI. CCC applications submitted without a collaborative DCC (U24) application will be deemed incomplete and will not proceed to review.

General Information

Document Type: Grants Notice
Funding Opportunity Number: PAR-16-300
Funding Opportunity Title: Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.233 — National Center on Sleep Disorders Research
93.837 — Cardiovascular Diseases Research
93.838 — Lung Diseases Research
93.839 — Blood Diseases and Resources Research
93.840 — Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders
Cost Sharing or Matching Requirement: No
Posted Date: May 31, 2016
Last Updated Date: May 31, 2016
Original Closing Date for Applications: Sep 13, 2019  
Current Closing Date for Applications: Sep 13, 2019  
Archive Date: Oct 14, 2019

Eligibility

Eligible Applicants:
Independent school districts
Native American tribal governments (Federally recognized)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Public and State controlled institutions of higher education
Small businesses
Public housing authorities/Indian housing authorities
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Special district governments
Private institutions of higher education
Others (see text field entitled “Additional Information on Eligibility” for clarification)
City or township governments
County governments
For profit organizations other than small businesses
State governments
Native American tribal organizations (other than Federally recognized tribal governments)
Additional Information on Eligibility: Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.

Additional Information

Agency Name: National Institutes of Health
Description: This Funding Opportunity Announcement (FOA) supports applications to develop and implement a Clinical Coordinating Center for investigator-initiated multi-site clinical trials (Phase II and beyond). Trials for which this FOA applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website: http://www.nhlbi.nih.gov.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PAR-16-300.html
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH OER Webmaster FBOWebmaster@OD.NIH.GOV
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

Advertisements

Notice of Intent to Publish a Funding Opportunity for a Clinical Trials Network for Emergency Care Research: Regional Clinical Centers (U24)

Notice Number: NOT-NS-15-021

Key Dates
Release Date:  May 5, 2015
Estimated Publication Date of Announcement: November 2015
First Estimated Application Due Date:  March 2016
Earliest Estimated Award Date:  December 2016
Earliest Estimated Start Date: December 2016

Related Announcements
NOT-NS-15-022
NOT-NS-15-023

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Advancing Translational Sciences (NCATS)

Purpose

The National Institute of Neurologic Disorders and Stroke (NINDS), the National Heart, Lung and Blood Institute (NHLBI), the National Center for Advancing Translational Science (NCATS), the Office of Emergency Care Research (OECR) in the National Institute of General Medical Sciences (NIGMS), and the Defense Medical Research and Development Program for Combat Casualty Care (DMRDP) intend to publish a Funding Opportunity Announcement (FOA) to solicit applications for an emergency care clinical trials network entitled Strategies to Innovate EmeRgENcy Care Clinical Trials (SIREN).  The network will be composed of a Clinical Coordinating Center (CCC), a Data Coordinating Center (DCC), and multiple Regional Clinical Centers with their linked clinical sites. The network will be charged with executing trials of high impact for the treatment of patients with neurological, cardiac, pulmonary, hematologic and traumatic medical and surgical emergencies.  Applications for SIREN trials will be solicited from the national scientific community. Investigator-initiated clinical trials that are considered highly meritorious by peer-review will be funded separately for execution by the network, in some cases coordinated with additional trial-specific sites.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in November, 2015 with an expected application due date in March, 2016.

This FOA will utilize the U24 activity code.

Research Initiative Details

This Notice encourages investigators with expertise in emergency care research, particularly neurologic, heart, lung, blood and trauma related indications, to begin to consider applying for this new FOA.

The SIREN network will be responsible for simultaneously executing at least 4 large, randomized, clinical trials that focus on improving care of patients with emergency conditions relevant to the mission of NINDS, NHLBI and the Defense Medical Research and Development Program for Combat Casualty Care (DMRDP) presenting to the pre-hospital or emergency department setting.  The Regional Clinical Centers will work collaboratively with the SIREN Clinical and Data Coordinating Centers, including use of the central IRB and master trial agreements formed by the Clinical Coordinating Center in coordination with the new Trial Innovation Centers being set up by the National Center for Advancing Translational Science.  Regional Coordinating Centers are expected to establish and work with subsidiary clinical sites, the identity and number of which may vary from protocol to protocol. The SIREN Regional Clinical Centers will be responsible for patient recruitment and treatment for SIREN studies

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Robin Conwit, MD
National Institute Neurologic Disorders and Stroke (NINDS)
Telephone: 301-496-3299
Email: conwitr@ninds.nih.gov

Monica Shah, MD, FACC
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0504
Email: shahmr@nhlbi.nih.gov

Jeremy Brown, MD
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-4481
Email: jeremy.brown@nih.gov

– See more at: http://grants.nih.gov/grants/guide/notice-files/NOT-NS-15-021.html#sthash.FDGAGySh.dpuf

Notice of Intent to Publish a Funding Opportunity for a Clinical Trials Network for Emergency Care Research: Data Coordinating Center (U24)

Notice of Intent to Publish a Funding Opportunity for a Clinical Trials Network for Emergency Care Research: Data Coordinating Center (U24)


Notice Number: NOT-NS-15-023NHLBI_Standard_Sig_Logo_RGB

Key Dates
Release Date:   May 5, 2015
Estimated Publication Date of Announcement: November 2015
First Estimated Application Due Date:  March 2016
Earliest Estimated Award Date:  December 2016
Earliest Estimated Start Date: December 2016

Related Announcements
NOT-NS-15-022
NOT-NS-15-021

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Advancing Translational Sciences (NCATS)

Purpose

The National Institute of Neurologic Disorders and Stroke (NINDS), the National Heart, Lung and Blood Institute (NHLBI), the National Center for Advancing Translational Science (NCATS), and the Defense Medical Research and Development Program for Combat Casualty Care (DMRDP), with expert consultation from the Office of Emergency Care Research (OECR), intend to publish a Funding Opportunity Announcement (FOA) to solicit applications for an emergency care clinical trials network entitled Strategies to Innovate EmeRgENcy Care Clinical Trials (SIREN).  The network will be composed of a Clinical Coordinating Center (CCC), a Data Coordinating Center (DCC), and multiple Regional Clinical Centers with their linked clinical sites. The network will be charged with executing trials of high impact for the treatment of patients with traumatic, neurologic, cardiac, pulmonary, hematologic and traumatic medical and surgical emergencies.  Proposals for SIREN trials will be solicited from the national scientific community. Investigator-initiated clinical trials that are considered highly meritorious by peer-review will be funded separately for execution by the network, in some cases coordinated with additional trial-specific sites.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

There will be three FOAs for the emergency care network, one for the CCC, one for the DCC and one for the Regional Clinical Centers.   This FOA for the DCC is expected to be published in November, 2015 with an expected application due date in March, 2016.

This FOA will utilize the U24 activity code.

Research Initiative Details

This Notice encourages investigators with expertise in emergency care research, particularly neurologic, heart, lung, blood and trauma related indications, to begin to consider applying for this new FOA.

The SIREN network will be responsible for simultaneously executing at least 4 large, randomized, clinical trials that focus on improving care of patients with emergency conditions relevant to the mission of NINDS, NHLBI and the DMRDP presenting to the pre-hospital or emergency department setting.   The DCC will be responsible for all components of data management, data quality and data analysis, including provision of data to Data Safety Management Boards.  The SIREN DCC will work closely and collaboratively with the SIREN Clinical Coordinating Center.  The CCC and DCC will be located at different institutions.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Robin Conwit, MD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-3299
Email: conwitr@ninds.nih.gov

Monica Shah, MD, FACC
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0504
Email: shahmr@nhlbi.nih.gov

– See more at: http://grants.nih.gov/grants/guide/notice-files/NOT-NS-15-023.html#sthash.hm4O45sv.dpuf

Notice of Intent to Publish a Funding Opportunity for a Clinical Trials Network for Emergency Care Research: Clinical Coordinating Center (U24)

Notice of Intent to Publish a Funding Opportunity for a Clinical Trials Network for Emergency Care Research: Clinical Coordinating Center (U24)


Notice Number: NOT-NS-15-022ninds

Key Dates
Release Date:   May 5, 2015
Estimated Publication Date of Announcement: November 2015
First Estimated Application Due Date:  March 2016
Earliest Estimated Award Date: December 2016
Earliest Estimated Start Date: December 2016

Related Announcements
NOT-NS-15-021
NOT-NS-15-023

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Advancing Translational Sciences (NCATS)

Purpose

The National Institute of Neurologic Disorders and Stroke (NINDS), the National Heart, Lung and Blood Institute (NHLBI), the National Center for Advancing Translational Science (NCATS) and the Defense Medical Research and Development Program for Combat Casualty Care (DMRDP), with expert consultation from the Office of Emergency Care Research (OECR), intend to publish a Funding Opportunity Announcement (FOA) to solicit applications for an emergency care clinical trials network entitled Strategies to Innovate EmeRgENcy Care Clinical Trials (SIREN).  The network will be composed of a Clinical Coordinating Center (CCC), a Data Coordinating Center (DCC), and multiple Regional Clinical Centers with their linked clinical sites. The network will be charged with executing trials of high impact for the treatment of patients with neurologic, cardiac, pulmonary, hematologic  and traumatic medical and surgical emergencies.  Proposals for SIREN trials will be solicited from the national scientific community. Investigator-initiated clinical trials that are considered highly meritorious by peer-review will be funded separately for execution by the network, in some cases coordinated with additional trial-specific sites.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in November, 2015 with an expected application due date in March, 2016.

This FOA will utilize the U24 activity code.

Research Initiative Details

This Notice encourages investigators with expertise in emergency care research, particularly neurological, heart, lung, blood and trauma related indications, to begin to consider applying for this new FOA.

The SIREN network will be responsible for simultaneously executing at least 4 large, randomized, clinical trials that focus on improving care of patients with emergency conditions relevant to the mission of NINDS, NHLBI and the Defense Medical Research and Development Program for Combat Casualty Care (DMRDP) presenting to the pre-hospital or emergency department setting.  The SIREN Clinical Coordinating Center, in coordination with the new Trial Innovation Centers being set up by the National Center for Advancing Translational Science, will form and manage a central IRB and master contract process for SIREN studies

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Robin Conwit, MD
National Institute Neurologic Disorders and Stroke (NINDS)
Telephone: 301-496-3299
Email: conwitr@ninds.nih.gov

Monica Shah, MD, FACC
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0504
Email: shahmr@nhlbi.nih.gov

DoD Funding Opportunities for the Peer Reviewed Cancer Research Program (UNCLASSIFIED)

ribbonDoD Funding Opportunities for the Peer Reviewed Cancer Research Program (UNCLASSIFIED)

Defense Health Program
Department of Defense Peer Reviewed Cancer Research Program
Funding Opportunities for Fiscal Year 2015 (FY15)

The FY15 Defense Appropriations Act provides $50 million (M) to the Department of Defense Peer Reviewed Cancer Research Program (PRCRP) to support innovative, high-impact cancer research. As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency, Research, Development, and Acquisition (DHA RDA) Directorate manages and executes the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The executing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP).

FY15 PRCRP Program Announcements and General Application Instructions for the following award mechanisms are posted on the Grants.gov website.

Congressionally Directed Topic Areas: To be considered for funding, applications for the FY15 PRCRP must address at least one of the Topic Areas as directed by Congress. Research applications in the areas of breast, prostate, lung (excluding mesothelioma), or ovarian cancer will not be accepted.

The FY15 PRCRP Topic Areas are listed below:

  • Colorectal cancer
  • Genetic cancer
  • Kidney cancer
  • Listeria vaccine for cancer
  • Liver cancer (New for FY15)
  • Melanoma and other skin cancers
  • Mesothelioma
  • Myeloproliferative disorders
  • Neuroblastoma
  • Pancreatic cancer
  • Stomach cancer (New for FY15)

 

Career Development Award – Pre-Application due June 1, 2015

 

Principal Investigator (PI): Independent early-career investigator within 10 years after completion of his/her terminal degree (excluding time spent in residency or on family medical leave) by the time of the application submission deadline.

Designated Mentor: Investigators at or above the level of Associate Professor (or equivalent); must have a proven publication and funding record in at least one of the FY15 PRCRP Topic Areas.

  • Preproposal is required; application submission is by invitation only.
  • Supports independent, early-career investigators to conduct impactful research with the mentorship of an experienced cancer researcher.
  • Must address at least one of the FY15 PRCRP Topic Areas.
  • Strongly encouraged to address at least one of the FY15 PRCRP Military Relevance Focus Areas.
  • Preliminary data are not required.

Clinical trials are not allowed.

  • Maximum funding for the entire period of performance is $360,000 for direct costs (plus indirect costs)

Maximum period of performance is 3 years

Idea Award with Special Focus – Pre-Application due June 1, 2015

 

Independent investigator at or above the level of Assistant Professor (or equivalent)

  • Preproposal is required; application submission is by invitation only.
  • Supports innovative, untested, high-risk/potentially high-reward concepts, theories, paradigms, and/or methods in cancer research that are relevant to Service Members, their families, and other military beneficiaries.
  • Emphasis on innovation and military relevance/impact.
  • Must address at least one of the FY15 PRCRP Topic Areas.
  • Must address at least one of the FY15 PRCRP Military Relevance Focus Areas.
  • Preliminary data are discouraged.

Clinical trials are not allowed.

  • Maximum funding for the entire period of performance is $400,000 for direct costs (plus indirect costs)

Maximum period of performance is 2 years

Translational Team Science Award – Pre-Application due June 16, 2015

 

At least three and up to five PIs across at least two institutions must partner in one overarching correlative or translational research study.
At least one Early Career Investigator within 10 years of completing a terminal degree (excluding time in residency or on family medical leave, and/or one military/Department of Veterans Affairs investigator must be included as an equal partner in the research offering both intellectual investment and research effort.

  • Preproposal is required; application submission is by invitation only.
  • Supports translational correlative studies associated with an existing clinical trial and/or translational study that can lead to a future clinical trial or clinical application in cancer research that is relevant to Service Members, their families, and other military beneficiaries
  • Not intended to support high-throughput screenings, sequencing, etc.
  • Must address at least one of the FY15 PRCRP Topic Areas.
  • Must address at least one of the FY15 PRCRP Military Relevance Focus Areas.
  • Preliminary data are required.

Clinical trials are not allowed.

  • Maximum funding for the entire period of performance is $1,200,000 for direct costs (plus indirect costs)

Maximum period of performance is 3 years

Horizon Award (to be released in July 2015)

 

PI: Both predoctoral candidates and postdoctoral fellows are eligible.
Mentor: The Mentor must be an experienced cancer researcher as demonstrated by a strong record of funding and publications. In addition, the Mentor must demonstrate a commitment to advancing the PIs career in cancer research.
The PI and the Mentor must be at the same organization.

  • Letter of Intent is required.
  • Supports junior level scientists to conduct impactful research with the mentorship of an experienced cancer researcher (i.e., Mentor)
  • Challenges junior scientists to develop and implement research in the cancer field.
  • Emphasis on discovery.
  • Must address at least one of the FY15 PRCRP Topic Areas.
  • Encouraged to address at least one of the FY15 PRCRP Military Relevance Focus Areas.
  • Preliminary data are not required.

Clinical trials are not allowed.

  • Maximum funding for the entire period of performance is $75,000 for direct costs (plus indirect costs)

Maximum period of performance is 1 year

A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final Program Announcements and General Application Instructions that are available for electronic downloading from the Grants.gov website. The application package containing the required forms for each award mechanism will also be found on Grants.gov. A listing of all CDMRP funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.

Applications must be submitted through the federal government’s single-entry portal, Grants.gov. Requests for email notification of the Program Announcements release may be sent to help@eBRAP.org. For more information about the PRCRP or other CDMRP-administered programs, please visit the CDMRP website (http://cdmrp.army.mil).

Point of Contact:

CDMRP Help Desk

301-682-5507

help@eBRAP.org