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Milestone Advice

Defining Milestones in R21 Research Project Grant (RPG) Applications

Milestones constitute a significant part of an R21 and small business grant application because they define the application's "deliverables," what a grantee will produce at the conclusion of an R21/Phase I grant. What constitutes a milestone has been problematic for certain applicants as the absence of well-constructed milestones often leads to difficulties in the review process. During review, reviewers are sometimes asked to propose milestones for a given application, particularly in cases where those milestones supplied by the applicant are deemed inadequate. Such a situation can lead to further difficulties in post-review negotiations between Program and a successful applicant as an application’s final milestones must be agreed upon prior to funding. Most importantly, inadequate milestones may result in a poor priority score.

Your application should include QUANTITATIVE benchmarks (i.e. milestones) to determine whether the specific aims of your R21/Phase I have been successfully achieved. In some cases qualitative milestones may be appropriate, but the gold standard is quantitative milestones. The most common error observed in applications is to present specific aims as milestones. Specific aims describe the goals of the research plan and define the path an applicant intends to follow. Quantitative or appropriate qualitative milestones determine how successful an applicant is/was in reaching his or her specific aims. Thus, at least one milestone for each specific aim should be provided. The accomplishment of the milestones should also establish proof of principle for all major aspects of the proposed Phase II work.

Examples of quantitative milestones include, but are not limited to:

  • Detection of one cancer cell in 106 normal blood cells;
  • dentification of 10 new cancer-associated cDNAs;
  • Detection of a target analyte at a concentration of 1 pmol/mL in serum;
  • Detection of one mutated gene in the presence of 65,000 normal genes;
  • Demonstration that the technology gives the same result in 95 out of 100 assays;
  • Demonstration that the technology is capable of detecting 25,000 different polypeptides from a cell or tissue type; and
  • Demonstration that the technology can be n-fold faster (or n-fold more sensitive, or less expensive, etc.) than the current "gold standard" technology.