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279 Facilitating the Transfer of Statistical Methodology into Practice

Number of anticipated awards: 2

(Fast-Track proposals will NOT be accepted. Phase II information is provided only for informational purposes to assist Phase I proposers with their long-term strategic planning.)

Budget (total costs): Phase I: $100,000;
Phase II: $750,000

(Note: It is strongly suggested that Proposals adhere to the above budget amounts. Proposals with budgets exceeding the above amounts may not be funded. Phase I project periods may last a maximum of 9 months.)

The deadline for receipt of all contract proposals submitted in response to this solicitation is: November 9, 2009.

Summary:
The development of new statistical methodology represents a key component of biomedical research. For cutting-edge statistical methodology to be used by people other than the developer, accompanying user-friendly, robust software is necessary. Often the developer of the statistical methodology does not have the time, knowledge, or skills to convert research-quality code for calculation engines into professional-quality software to be used by the general medical research community. In addition, the incentive mechanisms that drive a research statistician to put final touches on a paper submitted to a journal are not present to encourage a researcher to create user-friendly, robust software.

This SBIR announcement solicits submissions from small businesses interested in facilitating the transfer of newly developed cutting-edge statistical methodology with medical applications from the methodology developer to the user. The small business will consider the demand for the methodology, create user-friendly, robust software based on the calculation engine of the methodology developer, and make that software widely publicized and available. The small business will focus on creating software that is user-friendly, robust, and potentially interoperable with other common software packages that are part of the caBIG® initiative.

Project Goals:
The goal of this contract topic is to accelerate the time from the initial development of statistical methodology to when it can be readily used by a wide audience.

The short-term goal of this contract topic is to transfer the software of one important, highly-sought biostatistical technique from a research stage to a professional stage, developing the foundations in Phase I for a full-blown product to be completed in Phase II. In particular, the following steps should be accomplished:

  1. Consider the demand of the end-users to help in the choice of cutting-edge statistical methodologies. Confirm the lack of availability of existing professional-quality tools for those methodologies.
  2. Partner with the statisticians who developed the cutting-edge statistical methodology to create a professional software product based on the statistician's research code for one method or a suite of related methods.
  3. Test and refine the usability, robustness, and interoperability of the software and documentation. Solicit feedback from principle consumers and modify the product based on the feedback.
  4. Commercialize a professional final product, possibly by incorporating it into a widely used statistical package or creating a new package.
In preparing an application, the applicant should choose one cutting-edge biostatistical methodology (or a suite of related methodologies) that has excellent commercial potential and meets the following criteria:
  1. There is a demonstrated demand for the methodology and a lack of available professional software to implement the methodology.
  2. The developer of the statistical methodology has agreed to act as a consultant to verify the accuracy of the newly developed software. Research should be proposed that includes quantifiable, testable milestones for developing the software using the statistical methodology. Letters of support from potential user groups verifying the demand for the particular methodology chosen will strengthen an application. The long-term goal of this contract topic is to encourage small businesses to gain expertise in facilitating the quick transfer of cutting-edge statistical methodology from the academic or other developers to the medical researcher end-user, potentially via an existing software company. It is expected that once this process is developed, the small business could operate profitably, independent of government funding.

Phase I activities and expected deliverables:
  • Create a prototype of user-friendly, robust software for one methodology with appropriate documentation.
  • Test the robustness and usability of the software prototype by consulting a working group comprised of likely end-users.
  • Demonstrate comprehension of caBIG® methods, philosophy, and principles.
  • Provide program and contract officers with
    • Letter(s) of commercial interest to transfer the product, or
    • A detailed plan to commercialize the software (possibly as part of a new package) or to incorporate the software into a popular existing package.
  • Provide monthly reports.

Phase II activities and expected deliverables:
  • Based on the Phase I findings and feedback from the working group, create user-friendly, well-tested, robust software with full user interfaces for the methodologies with appropriate, full documentation and instructional materials.
  • Demonstrate capability to obtain caBIG® bronze/silver compatibility.
  • Obtain an affidavit from the developer of the original methodology, stating his/her belief that the software is accurate. The developing statistician must be consulted until he/she is comfortable signing the affidavit.
  • Present the products at a statistical and/or non-statistical conference and to an NCI evaluation panel.
  • Provide program and contract officers with letters of commercial commitment to transfer the product (if applicable).
  • Provide program and contract officers with quarterly reports. The final report should evaluate the strengths and weaknesses of the process by which the technology was transferred from the academic researcher to the end user.
  • Research should be proposed with a refined commercialization plan based on Phase I findings and quantifiable, testable milestones.

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