NIH Data Coordinating Center for the HALT-Polycystic Kidney Disease Trials (U01)

WHAT: Limited Submission Proposal for the NIH Data Coordinating Center for the HALT-Polycystic Kidney Disease Trials (U01) Program

WHO:  Texas A&M University faculty, including TAES, TEES and TTI personnel.

WHY:  Applicants may request up to $700,000 in direct costs for each year for a maximum period of five years.

WHEN: Internal proposal deadline of November 5, 2007.

HOW:  Faculty should submit internal proposal via email for review by the internal selection committee.

THE FINE PRINT:

The funding agency, NIH, has limited the number of proposals to two per institution.

BRIEF PROGRAM DESCRIPTION:  The NIH Data Coordinating Center for the HALT-Polycystic Kidney Disease Trials (U01) Program is designed for the ongoing HALT-Polycystic Kidney Disease (PKD) Trials, which are currently in the enrollment phase.  Two multicenter randomized clinical trials are on early disease (Study A) and moderately advanced disease (Study B).  The primary objective of this RFA is to provide for continued DCC support so that HALT-PKD data collection and analysis can be completed as planned.  The HALT-PKD DCC will provide coordination, assistance, centralized data management and analytical support for all HALT-PKD studies.  Further, the DCC responsibilities include logistical support for the HALT-PKD steering committee. 

The Data Coordinating Center will:  provide statistical and data analysis expertise for HALT-PKD studies; establish and manage a secure and confidential computerized system to collect study data (including kidney and cardiac imaging data), provide quality assurance for and report on study data, and establish electronic communication linkages between clinical sites and the DCC; prepare reports and analyses to be used for steering committee meetings, data and safety monitoring board (DSMB) meetings, relevant regulatory reports (i.e. FDA or other required reporting), presentations and publications; establish, maintain and provide appropriate oversight to the subcontracts for Central Laboratories, study medication distribution and other necessary adjuncts to the study; coordinate procedures for coding, shipping, processing, receipt and storage of study samples that are to be maintained in the repository; and provide logistical support for meetings and teleconferences of the steering committee, including budgeted support for travel, lodging, meeting values and teleconferences.     

Data sharing in the HALT-PKD consortium will have three components:  data sets from clinical centers will be shared within the HALT-PKD consortium during the clinical trials, becoming part of a common data set that will be maintained at the DCC and that will be the basis for analysis of study endpoints; the HALT-PKD consortium will also publish their research results and share with the scientific community and the general public; and the HALT-PKD data set will ultimately be transferred to the NIDDK Data Repository after the clinical trials have been completed and the primary data paper(s) published. 

Applicants may request up to $700,000 in direct costs for reach year for a maximum period of five years.  Applications submitted by foreign organizations should use an indirect cost rate of 8%.  Principal Investigators should have expertise in the management of large interventional drug trials, including a Masters Degree or Doctorate in Clinical Epidemiology, Biostatistics, or a related field, as well as experience in the studies of kidney disease.  The PI of the DCC shall be a member of the HALT-PKD steering committee.  In addition, this RFA is not intended to support the HALT-PKD clinical centers.

More information can be found here.        

Internal Selection Procedures and Deadlines

November 2, 2007:  Deadline for an email of intent, including the names of the PI and co-PIs, title of internal proposal and a 1-3 sentence description of the project.  Send email of intent.

November 5, 2007: Deadline to obtain signatures of approval from your department head and college dean to submit an internal proposal to the Office of Sponsored Projects for review by the internal selection committee.  The internal proposal should include:

• An executive summary, up to three pages, based on the proposal description as outlined in the NIH program announcement
• Summary budget
• Project and Management Plans (including team members)

The form for completing the internal proposal is here.

This completed form should be submitted electronically for review by the internal selection committee.

Please read the RFP carefully for specific requirements of the program here.

Selection of a proposal will be based on NIH guidelines.  The needs of the university’s reinvestment plan will also be taken into account. 

During the selection process, the internal selection committee may contact departments and colleges for their opinions and commitments.  They may also request additional information from PIs.

November 16, 2007: The Internal Selection Committee will notify PIs of the result of the internal competition.

November 20, 2007:  Deadline for optional, but recommended, letter of intent.

December 13, 2007:  Deadline for full proposal.