A Walk Through Phase I SBIR

1. A Walk Through Phase I SBIR/STTR Applications (& the New SF424 Form) Connie Dresser, RDPH, LN Program Director, Multimedia Technology & Health Communication SBIR Grants Health Communication & Informatics Research Branch Behavioral Research Program Division of Cancer Control & Population Sciences National Cancer Institute 6130 Executive Blvd, EPN - Rm. 4072 Bethesda, MD 20892-7365 301/435-2846; 301/480-2087 Fax cd34b@nih.gov

2. SBIR/STTR Terms - SBIR grants and contracts: Small Business Innovation Research – businesses team with consultants from non-profit organizations STTR grants: Small Business Technology Transfer – non-profit organizations team with small businesses

3. Agenda SF424 Form – electronic applications begin: 12/1/05 Programmatic Goals of the Multimedia Technology and Health Communication SBIR/STTR Program Information Proven to Get You Funded - Scientific content that applies to SBIR/STTR grants & SBIR contracts Research Plan - Relevant Experience - Specific Aims - Significance - Design and Methods - Sampling & Participant Issues - Additional Dos - Don’ts Contents of Program Home Page FY06 SBIR Topics - Gaps in Research Program Requirements

4. SF424 Form Forms and assistance for defining terms: Url: http://grants2.nih.gov/grants/funding/424/index.htm Once in the form, click on the 1st ? mark icon on the toolbar at the top of the form. This activates the hover button. • The SF424 is currently used for SBIR/STTR and Fast Track applications. Contracts use a different form that is not electronic at this time

5. Programmatic Goals The goals of the NCI Multimedia Technology and Health Communication SBIR/STTR Program are to: fund science-based, theory-driven, user-centered grants and contracts to translate cancer research into programs, interventions, systems, networks, or products needed by professionals or the public to reduce cancer risk or improve the quality of life of cancer survivors; promote the use of innovative media technology and/or communication approaches in cancer prevention and control applications used in medical and community settings; improve communication behaviors of primary care professions, patients, and care-givers in cancer-related matters; promote organizational infrastructures changes that promote the use of products developed in the program; promote the development of system models; and expand the methods for evaluating ehealth research and developed products.

6. Information Proven to Get You Funded Research Plan - Relevant Experience: Convene an outstanding “team” of co-investigators and consultants who can compensate for the PI's lack of subject-area expertise. PI does not have to have a Ph.D. or M.D. The primary responsibility of the PI is to manage the project and provide either research or technology expertise. Hire consultants familiar with the subject matter of your proposal and who can address the statistical, behavioral, and evaluation aspects of the grant. Secure their advice and ask them to review your application prior to submission. Cite qualifications, experiences, accomplishments of the principal investigator, research team and consultants that apply to the current project. On the CV, only include publications relevant to the proposed product.

7. Research Plan - Relevant Experience (cont): Include letters of commitment from key partners or university officials working on the project. Include letters of participation and support from your technical and advisory members. ++: Include letters of potential backing from commercial collaborators. While the letters are not mandatory in a Phase I, they are in a Phase II. Information Proven to Get You Funded

8. Information Proven to Get You Funded Research Plan - Specific Aims: • State the global objectives of your Phase I/II grant and the steps to meet your Phase I aims. • Present a strong argument for developing the product based on NCI programmatic needs, a review of the current literature, and a review of comparable products in the marketplace.  State concisely and realistically how you intend to demonstrate feasibility – the focus of a Phase I SBIR, in 6 months - 1 year. (contracts – only 6 months) Describe potential end-users of your product, i.e., patients, caregivers and how the product will benefit them. Indicate types of collaborators for Phase II commercialization, i.e., worksites, high schools, HMOs, clinics, etc.

9. Information Proven to Get You Funded Research Plan - Significance: • Define the existing cancer–related situation or gap in research that prompted the development of your concept and product. • Define your study rationale, i.e., population, variables. • In table form, note the pros and cons of your intended product and describe how it differs from other similar products in the marketplace, including its projected cost and time-saving benefits. • While your study should be focused on cancer, indicate how your intended product could be used as a “model” for addressing other chronic diseases.

10.  Information Proven to Get You Funded Research Plan – Design and Methods: Present a clear theoretical framework for the overall Phase I/II project Support your theoretical assumptions with current literature Make sure that your Phase I aims and objectives match the study design Provide pilot data, if available (not mandatory). Be realistic about how many variables are included and criteria used to evaluate feasibility in the Phase I Include potential end-users in the Phase I and conduct appropriate usability testing Address limitations or potential barriers of the overall study Address barriers and resolution to product use Provide a paragraph about your development, implementation and evaluation plans for Phase II.

11. Information Proven to Get You Funded Research Plan - Sampling & Participant issues: Even if you have one human being in your study, you must adhere to all policies for human subjects, unless you are exempt. Information about NIH Medical & Behavioral Research Grant Policies, Guidelines can be found at: http://grants1.nih.gov/grants/oer.htm Include a sufficient Phase I sample for focus groups to provide proof of feasibility Provide a strong justification for your study population Include sample sizes, gender, age, race, culture, and other needed demographic information; fill out your targeted enrollment form Provide your focus group sampling method and a backup enrollment plan

12. Information Proven to Get You Funded Research Plan - Sampling & Participant issues (cont): Adequately address the inclusion or exclusion of minorities, women or children Include a consent form sample paying attention to audience appropriateness (literacy level, language) Address potential burden on subjects Address socioeconomic and diversity issues, appropriate audience approaches, and barriers to behavior change. Use statistically valid measures to evaluate feasibility • Cite your grant performance site types, i.e., HMO, clinics 

13. Additional Dos Hire a grant writer if you cannot convey your thoughts on paper! Never assume that the reviewers will know what you mean without ample clarification. Submit an innovative concept that meets a consumer need and has the potential to motivate behavior change that will result in cancer risk reduction or improve quality of life. Submit a focused, comprehensive and complete application Use appropriate modes of media communication for the target population Double check your citation procedures Pay attention to acceptable fonts and other SF424 instructions Provide adequate information about your facilities to conduct research Provide a concise budget and justification Cite potential interested parties as promoters or collaborators for the Phase II 

14. DO NOT use incomplete sentences or cut and paste from other applications submit an application with insufficient details or information repeat information to fill the application talk around the subject give up! PERSIST PERSIST PERSIST

15. The NCI SBIR Multimedia Technology Health Communication Homepage - Under Major Revision (http://cancercontrol.cancer.gov/hcirb/sbir/ ) Program Overview Tools for Applicants Expectations of Applicants Grant Portfolio Funding Improve Funding Potential Research Priorities Research Outcomes New: Investigators interested in applying for grants in this program should refer to the electronic FY06 SBIR solicitation Manual (http://grants.nih.gov/grants/funding/sbir.htm). The manual will direct you back to this homepage where a list of gaps in ehealth research will be provided.

16. FY06 SBIR Topics - Gaps in Research*  Programs that enhance self-awareness that lead to health awareness and taking responsibility for preventing or managing chronic diseases 2) Systems to capture family health histories and related health information Effective tools for collecting and integrating patient informatics into the workflow of medical environments using wireless technologies 4) Technology tools for health professionals 5) Smart home monitors for cancer patients and their care givers 6) Products that lead to widespread IT adoption that lead to transformation of a health care system Comprehensive resources to map the future of survivors of childhood cancers Programs to improve communication with patients at end of life An online second opinion Discussion boards for Hispanics Programs to educate physicians and patients about reproductive health after cancer treatment * Listed in order of NCI interest

17. Phase II Program Requirements for SBIR/STTR Grants and SBIR Contracts APPLICANTS are required to: 1) include a site administrator on their grant who can advise and help remove infrastructure barriers that will limit the use of the proposed product. If your product faces no infrastructure problems, state so in the application. devise a means of tracking sales and purchaser demographics without name identification. participant in product evaluation at NCI’s User-Centered Informatics Research Center. Applicants should include $23,000 for evaluation in their Phase II application. participate in an NCI “Linking Science and Business Products Showcase” in the latter part of their last year of research. Travel expenses should be included in the Phase II application. publish grant results in at least one peer-reviewed publication.

18. Phase II Program Requirements for SBIR/STTR Grants and SBIR Contracts (cont) Submit a final report that includes: - Grantee name, company, location, - Product Name phone, fax, email - Product Type - Names & affiliations of research team - JPEG of final Product - Grant number; grant title - Audience (user) - Abbreviated abstract - Product Awards - Theory/hypotheses - Peer Reviewed Publications in - Research objectives/aims progress or published - Study demographics; final - Presentations sample size - Organizations/consortiums - Information collection methods worked with during the grant - Outcome measures - Commercial collaborations or - Evaluation methods potentials - Research Results – what worked, - A copy of the final product when what didn’t available - Limitations, Barriers & Resolutions