Funding

Clinical Research

Updated September 10, 2007

The NIAMS Narrative Application Guide For Studies Involving Biospecimens In The Doxycycline Trial Repository

This document summarizes guiding principles involved in applying for use of biological specimens from the Doxycycline Trial Biospecimens Repository. This document describes the NIAMS review process for studies requesting use of these specimens.

Types of specimens available for ancillary studies

Type of Specimen
Maximum allowable specimen per biomarker
EDTA plasma 200 µl (total plasma per any individual biomarker for duplicate analyses)
Urine

500 µl (total urine per any individual biomarker for duplicate analyses)

Serum is not available. See document "Description of Doxycycline Trial Repository Sample" for full details of sample type and biomarkers analyses already completed or in the process of analysis.

Review and approval process

All study proposals requesting biospecimens must be reviewed for feasibility by the Biomarkers Review Committee.

The NIAMS Program Officer will issue a letter of response after review is complete.

How to Apply:

  1. There are two receipt dates per year, they are June 1 and Oct. 1 (or the next working day)
  2. Complete the “Application Form for Biospecimens from the Doxycycline Trial Repository", and the "Narrative Proposal" (see details below).
  3. Submit the biospecimen application and the narrative proposal electronically to the administrator for the Biomarkers Review Committee : Doxyspec@kai-research.com
  4. The full review process takes approximately three months . You may receive questions from the Biomarkers Review Committee to clarify the proposal further. Upon approval, the NIAMS Program Officer will provide the final notification of approval. If the proposal is turned down, a written explanation of the reasons for declining will be provided. If these can be effectively addressed, a proposal may be resubmitted.

When external funding is pending: specimens will only be dispersed when a letter from the funding agency is provided to the NIAMS Program Officer to confirm that funding has been approved and the proposal is funded.

Very Important - Please Note : The cost of shipping and handling of the samples is the responsibility of the PI and must be provided by the PI. Use of samples is dependent upon having an adequate plan to make the data available to other investigators for use in collaborative and correlative analyses.

For further information pertaining to the sample availability, please contact Dr. Virginia Krauss : 919-681-6652 vbk@acpub.duke.edu

Narrative Proposal Format

The narrative proposal format should conform to the following specifications and will be submitted electronically:

  • Maximum of 10 pages (including abstract, tables and figures) not including references. Proposals that are longer than 10 pages will be returned for editing.
  • 12 pt. font
  • It is imperative to justify sample size (total N) and amount of specimen requested:
    • EDTA plasma in µl
    • Urine in µL

To assure an efficient review process, these points should be clearly and fully described in your 10 page submission (please see attached template):

  1. A 200 word abstract that can be used to communicate the key objectives
  2. Specific Aims
  3. Background and significance, including the potential to contribute to the health of OA Patients Include information on performance characteristics of the biomarker
  4. Methods, including all of the following that are applicable:
    • Biomarker performance characteristics
    • Sample Request (types of samples, volume, and justification for the amount of the specimen requested )
    • Laboratory methods (be specific about analytes and assays)
    • Methods of analysis
    • Other (method of funding, documentation that budget includes funding to retrieve and ship specimens, timeline for assays, plan for data sharing )
  5. Investigator qualifications
  6. Resources and environment (expertise and capabilities to be able to conduct proposed research)
  7. References

(a-g must not exceed 10 pages)

Biomarker Study Review Criteria

Scoring note: 1 = high priority     2 = moderate priority     3 = low priority

I. Scientific Review

Significance : Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced?

Approach : Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project?

Innovation : Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigator(s) : Are the investigators appropriately trained and well suited to carry out this work?

Environment : Does the scientific environment in which the work will be done contribute to the probability of success?

II. Operational Criteria (not scored)

Meets Criterion?

Appropriate plan for disposition of remaining sample

Y / N / NA

Adequate plan for data sharing

Y / N / NA

III. Overall Recommendation

1 / 2 / 3

Following review and approval of the application the NIAMS Program Officer will send an approval letter to the PI. PI may use the approval letter in applications for funding and to obtain the specimens from the repository. The letter is good for 18 months .