E9-16695. Dual Antiplatelet Therapy Trial: Research Project Grant (R01)

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Office of Critical Path Programs (OCPP). The goal of the Dual Antiplatelet Therapy (DAPT) Trial is to solicit a sole source grant application from Harvard Clinical Research Institute (HCRI) that proposes to provide funding in support of a dual antiplatelet therapy clinical trial being conducted by HCRI.

DATES:

Important dates are as follows:

1. The application due date is August 12, 2009.

2. The anticipated start date is in September 2009.

3. The opening date is July 14, 2009.

4. The expiration date is in May 2010.

FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT:

Nancy Stanisic, Office of Critical Path Programs (HF-18), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1660.

Vieda Hubbard, Office of Acquisitions and Grants Services, (HFA-500), Food and Drug Administration, 5630 Fishers Lane, Rockville, MD 20857, 301-827-7177.

For more information on this funding opportunity announcement (FOA) and to obtain detailed requirements, please refer to the full FOA located at http://www.fda.gov/​oc/​initiatives/​criticalpath/​.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

Request for Applications (RFA) Number: RFA-FD-09-016

Catalog of Federal Domestic Assistance Number: 93.103

A. Background

OCPP is soliciting a sole source grant application from HCRI that proposes to provide funding in support of a dual antiplatelet therapy clinical trial being conducted by HCRI.

Given the lack of randomized data, there is considerable uncertainty in the medical community about the optimal duration of dual antiplatelet therapy following Percutaneous Cardiac Intervention. It is unclear as to whether the duration of dual antiplatelet therapy in patients receiving Drug Eluting Stents (DES) should be 3 to 6 months (as was prescribed in the pivotal DES randomized trials conducted for premarket approval), 12 months (as per the American College of Cardiology/American Heart Association/Society for Cardiac Angiography and Interventions guidelines), or even longer. It is also unknown whether the presumed benefit of extended dual antiplatelet therapy is specific to DES or whether non-Acute Coronary Syndrome patients treated with BMS (e.g. stable angina) may also benefit from extended dual antiplatelet therapy. With these considerations in mind, it is imperative that the risks and benefits of continued clopidogrel use be evaluated to determine, with greater precision, the optimal duration of dual anti-platelet therapy. This trial will be conducted with the unprecedented cooperation of four device manufacturers and two drug manufacturers under the direction of HCRI.

B. Research Objectives

The Research Project Grant (R01) is an award to support a discrete, specified, circumscribed project to be performed by HCRI in areas representing the investigators' specific interests and competencies based on the mission of FDA. The development of the DAPT trial represents an important and critical new paradigm for FDA and the medical product development community —having identified a critical public health issue in a combination product that impacts hundreds of thousands of American patients, the device and drug industries are collaborating together to address this question with a single trial. The advantages of this concerted effort are obvious—obtaining an answer more quickly and with fewer resources expended. The study is unprecedented in the level of cooperation, both internal and external, that is required.

FDA awards R01 grants to institutions/organizations of all types. This mechanism allows the program directors/principal investigators (PDs/PIs) to define the scientific focus or objective of the research based on particular areas of interest and competence. Although the PDs/PIs write the grant application and are responsible for conducting and supervising the research, the actual applicant is the research institution/organization.

One of OCPP's mandates is to identify and promote the development of collaborative partnerships and support mechanisms of innovative trial design. Innovative clinical trial design may make it possible to develop accepted protocols for smaller but smarter trials or trials that can be conducted with collaboration of multiple device and drug manufacturers. The development of the DAPT trial represents an important and critical new paradigm for FDA. When a critical public health issue is identified in a combination product that impacts thousands of American patients, the concerted effort of multiple parts of the agency can bring the members of the regulated industry and clinical community to develop a clinical trial that will provide the answers needed by practicing physicians.

C. Eligibility Information

This award will be made to HCRI.

II. Award Information/Funds Available

A. Award Amount

The total amount of funding that the agency expects to award through this announcement is $1.5 million. There will be one award.

B. Length of Support

The total project period for the application submitted in response to this funding opportunity may not exceed 2 years.

III. How to Submit a Paper Application

To submit a paper application in response to this FOA, applicants should first review the full announcement located at http://www.fda.gov/​oc/​initiatives/​criticalpath/​. Persons interested in applying for a grant may obtain an application form at http://grants.nih.gov/​grants/​forms.htm. For all paper submissions, the following steps are required:

• Step 1: Obtain a Dun and Bradstreet (DUNS) Number
• Step 2: Register With Central Contractor Registration
• Step 3: Register With Electronic Research Administration (eRA) Commons

Steps 1 and 2, in detail, can be found at http://www07.grants.gov/​applicants/​organization_​registration.jsp. Step 3, in detail, can be found at https://commons.era.nih.gov/​commons/​registration/​registrationInstructions.jsp. After you have followed these steps, submit paper applications to: Vieda Hubbard (see FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT).

Dated: July 8, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.