A Walk Through Phase I SBIRSTTR Applications

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• 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_at_nih.gov

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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

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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
• - Donts
• Contents of Program Home Page
• FY06 SBIR Topics - Gaps in Research
• Program Requirements

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SF424 Form

• Forms and assistance for defining terms
• Url http//grants2.nih.gov/grants/funding/424/i
  ndex.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

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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.

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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.

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Information Proven to Get You Funded

• 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.

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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.

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Information Proven to Get You Funded

• Research Plan - Significance
• Define the existing cancerrelated 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.

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• 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.

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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

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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

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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

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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

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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.

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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

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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 NCIs
  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.

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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 didnt available
• - Limitations, Barriers Resolutions