DoD Tuberous Sclerosis Complex Clinical Research Award

Post Date

February 16th 2010

Application Due Date

June 25th 2010

Funding Opportunity Number

W81XWH-10-TSCRP-CRA

CFDA Number(s)

12.420

Funding Instrument Type(s)

Cooperative Agreement
Grant

Funding Activity Categories

Science and Technology and other Research and Development

Number of Awards

1

Eligibility Categories

Unrestricted

Funding

• Estimated Total Funding:

  $1800000

• Award Range:

  $None - $None

Grant Description

The TSCRP Clinical Research Award mechanism was first offered in FY08. This year the program seeks to fund clinical and translational studies which emphasize research with human subjects. Preclinical studies will be considered. Interdisciplinary collaboration are also encouraged Award Description Important aspects of this award mechanism are as follows: 1. Preliminary Data: Unpublished results from the laboratory of the Principal Investigator (PI) or collaborators named on this application, that is relevant to the proposed research project is required. Proposals should also be based on a sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature.2. Optional Qualified Collaborator: The FY10 TSCRP strongly supports collaborative research. Collaborations that bring new perspectives from other disciplines, are interdisciplinary or bring new investigators into the TSC field are strongly encouraged. Collaborations that meet the criteria below will qualify for a higher level of funding as described in Section I.E. For the application to qualify for the higher level of funding, the Principal Investigator (PI) must submit a Statement of Collaboration that clearly identifies the collaborating investigator and addresses how each of the criteria below are met. Additionally, the collaborator must provide a letter of collaboration describing their involvement in the application. It should be clear that the success of the project depends on the unique skills and contributions of each partner. • The collaborator must significantly contribute to the project such that the proposed work could not be accomplished without his/her involvement. • Either the PI or the Collaborator must have TSC research experience as demonstrated through publications and/or funding history. • The collaborator must be at or above the level of Assistant Professor (or equivalent). • At least a 10% level of effort is required of the collaborator. Contribution of the collaborator should be reflected in the application’s budget. Examples of Collaborations that do not qualify include: Reagents supplied by one collaborator and molecular studies completed by the other collaborator, service function or core support providing laboratory investigations or statistical analyses, projects that can be accomplished in a single PI’s laboratory. 3. This award may support either clinical/translational research studies or (a) Clinical/Translational Research Studies clinical trials. Each application may only include one of these types of studies. Preference will be given to studies involving human subjects but preclinical studies will be considered. Each application may only include one of these types of studies. Studies may include clinical research conducted with human subjects (or material of human origin such as tissues, specimens and cognitive phenomena), correlative studies associated with existing clinical trials, translational studies with an emphasis on human subjects and biomarker studies. Preclinical studies will be considered. Developmental pathways for translational research that may be useful for designing translational research studies for support under this mechanism may be found at (http://www.cancer.gov/aboutnci/trwg/Pathways-to-Clinical-Goals). These pathways are comprehensive and span the entire translational research continuum. (b) Clinical Trials The TSCRP CRA supports research with the potential to have a major impact on the treatment or management of tuberous sclerosis. In general, a clinical trial is defined as a prospective accrual of patients for a study where an intervention (e.g., device, drug, behavioral, surgical procedure, or other) is tested on human subjects for a measurable outcome. Refer to the General Application Instructions, Appendix 5, for additional information about studies involving human subjects. The proposed clinical trial is expected to begin no later than 12 months after the award date. If an application requests support for a clinical trial, the PI is required to submit a clinical protocol in addition to the project narrative by the application receipt deadline. Guidelines for clinical protocol preparation are outlined in Section VI. The protocol will be reviewed separately according to the review criteria outlined in Section V. Applications that include a clinical trial but do not submit a clinical protocol will be administratively withdrawn.Each application should contain only one clinical trial with a distinct study design. Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications should be submitted or approved prior to application submission. If the study is in support of an application to the U.S. Food and Drug Administration, Investigation New Drug (IND) or Investigational Device Exemption (IDE) applications should be submitted prior to the grant application submission. The Government reserves the right to withdraw funding if an active exemption from marketing approval for the IND or IDE has not been acquired within 6 months of the award date. If an Investigational New Drug (IND) or Investigational Device Exemption (IDE) is required to conduct the proposed research, but is not received within 6 months of the award date, the Government reserves the right to revoke funding. For descriptions of each type of clinical trial, please refer to http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/default.htm and http://www.clinicaltrials.gov. Refer to the General Application Instructions, Appendix 5, for helpful information about distinguishing clinical trials and research utilizing human anatomical substances. The proposed clinical trial is expected to begin within 12 months of the award date.

Contact Information

• Agency

  Department of Defense

• Office:

  Dept. of the Army -- USAMRAA

• Agency Contact:

  PA HELP: 301-619-7079; cdmrp.pa@amedd.army.mil
  eReceipt HELP: 301-682-5507; help@cdmrp.org
  

• Agency Mailing Address:

  CDMRP Help Desk

• Agency Email Address:

  cdmrp.pa@amedd.army.mil