Request for Collaboration for a Central Genetics Laboratory

 

Request for Collaboration for a Central Genetics Laboratory

The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE) is a long-term study of different treatments for type 2 diabetes.

GRADE is a multicenter NIDDK-supported clinical trial that is comparing four commonly used classes of glucose-lowering medications (sulfonylureas, DPP-4 inhibitors, GLP-1 receptor agonists, basal insulins) added to metformin in individuals who have had type 2 diabetes  for <10 years duration. Participants will be followed through quarterly visits for between 4 and 7 years. The protocol is provided below, along with other necessary documents.  As part of the protocol, the study group collected DNA at baseline from the 5,047 randomized participants and has sufficient high quality material on >95% of these individuals. In addition to this genetic material, stored plasma is available on these participants along with a variety of phenotypic data including measures of insulin sensitivity and islet beta-cell function from oral glucose tolerance tests.

The Central Genetics Laboratory (CGL), a central resource unit to the study group, will collaborate as a Co-investigator in GRADE and will be funded via a sub-agreement with the George Washington University. The Central Genetics Laboratory will collaborate in the design of GRADE genetic studies, will conduct the genetic assays and will participate in the interpretation of statistical analyses and the co-authorship of presentations and publications. The laboratory will provide requests for reports on data quality, response time and annual performance. The laboratory director will represent the laboratory at appropriate GRADE Research Group meetings, including those of the Steering Committee. The GRADE study group is chaired by David Nathan and the Coordinating Center is the George Washington University Biostatistics Center under the direction of John Lachin.

The centers that apply to become the GRADE Genetics Center will be required to submit a scientific proposal describing how they intend to utilize the GRADE genetics samples to greatest scientific advantage. The center selected, by an NIH-style peer review, will then work with the GRADE Study Group to develop an NIH proposal for funding.

The deadline for Letters of Intent is July 10, 2018 and the deadline for Applications is August 15, 2018.

We hope you will peruse the GRADE RFC and other documents below and consider submitting a proposal.  Questions should be directed to:  GRADE.LabApplications@bsc.gwu.edu.

Docs

FAQs

 

FAQs and Other Announcements Last Updated August 6, 2018 (click here to download FAQs)

  1. Q: Will GRADE DNA samples be sent in matrix plates (with barcodes) or in tubes?
    A: The GRADE Central Biochemistry Laboratory at the University of Minnesota will retain the GRADE DNA, and will only provide the quantity needed for the collaborator to perform their proposed analyses. Providing information in the application as to how much DNA you will require would be appreciated. The DNA will be transferred to a barcoded Matrix plate.
  2. Q: Two years is allocated for genotyping. What if we project that it can be done in less time?
    In that case you should feel free to propose a modified time line and work tasks for 3 years of activity and still prepare a 3-year budget request.
  3. Q: We have identified consultants who bring additional expertise. Should we include their NIH Biosketches?
    A: Biosketches are required for key personnel and are optional for others.
  4. Q: Is a letter of support also required?
    A: This is optional.
  5. Q: Your RFA states that a senior geneticist should be the lead. Could an expert in another discipline qualify?
    A: The PI and co-investigators may be of any allied discipline felt by the applicant to be needed for a successful application to NIH.
  6. Q: Page 7 lists the activities that should take place during “Months 28-36” and for the “Final 9 months of the study” – are these referring to the same time period?
    A: Yes, months 28-36 are the final 9 months of the projected 3 year grant period.
  7. Q: Does GRADE have RNA? Or samples collected in PAXgene tubes to facilitate RNA extraction?
    A: No RNA was extracted from GRADE study participants, nor were Paxgene tubes collected.
  8. Q. With regards to the electronic data transmission from the CGL to the Coordinating Center, is the expectation to receive the genomic data following QC or are you also looking for the raw data?
    A. Only the data following QC.
  9. Q: Are the references included in the 12 page limit for the Research Plan?
    A. No.
  10. Q: The association analyses will be conducted primarily by the biostatisticians at the GRADE CoC. We are budgeting the computing costs for QC/imputation of the genomic data. Should we also include the association analyses costs if they will be done at GWU and not at our site?

      A: We advise that you budget for QC as mentioned in your email, but not for the costs of the association analyses.