Digital Health Technologies to Address the

Social Determinants of Health in context of

Substance Use Disorders (SUD)

Webinar #4: Writing Good Specific Aims

and Approach

Victor Prikhodko, Business Advisor [C]

Office of Translational Initiatives and Program

Innovations (OTIPI), Office of Director (OD)

NIDA

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https://sbir.nih.gov/infographic

Complete Five Required

Registrations as soon as possible.

Informational Webinars to break

down the application process3

Environment and Investigators

Tuesday June 20, 2019

Significance and InnovationTuesday June 25, 2019 2-4PM EDT

Specific Aims and Approach

Thursday June 27, 2019, 12-2PM EDT

Commercialization PlanTuesday July 2, 2019, 2-4PM EDT

https://sbir.nih.gov/nida/RFA%3ASocial_Determinants

Due Date

July 29th, 2019 5pm

Introduction to SDoH RFATuesday June 18, 2019

4Presentations are Publicly Available

Specific Aims and Approach

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https://www.niaid.nih.gov/grants-contracts/prepare-your-application

Specific Aims

Specific Aims – a one page

statement of your objectives for

the project

In your Specific Aims, you note

the significance and innovation

of our research; then list your two

or three concrete objectives,

your specific aims

Some people write their Specific

Aims first and then develop a

hypothesis; others do the reverse.

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https://www.niaid.nih.gov/grants-contracts/draft-specific-aims

A strong hypothesis should be well-focused and testable by the Specific

Aims and experiments.

Writing Good vs. Poor Specific

Aims

A common type of Specific Aim might ask a question like “Does A cause

B?” However, your project could come to an end if A doesn’t turn out to cause B.

It’s better to design an aim where the result doesn’t depend on only one

outcome, but where one or more different outcomes would also be of

interest. Then the question becomes “Does A cause B or non-B,” so make

sure the “non-B” outcomes make sense based on both your central

hypothesis and preliminary data.

Another common type of Specific Aim is descriptive. For example, “We will

measure levels of X in 1,000 samples of Y to characterize the pattern of

expression of X."

Though this may be very doable, it is rarely a highly significant finding in

itself and often should be avoided unless you have no other choice. Such

descriptive findings should usually be part of your preliminary data, not

part of your proposal.

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https://www.niaid.nih.gov/grants-contracts/draft-specific-aims

9 Specific Aims in Phase I must

demonstrate feasibility

10Case Study: Drug Diversion in Hospitals

Case Study: Drug Diversion in

Hospitals11

15% 10% 8%

Among health care providers, it is estimated that 15% of pharmacists, 10% of

nurses, and 8% of physicians are challenged with alcohol and/or drug

dependency.

Case Study: SAs in Phase I

must demonstrate feasibility12

https://projectreporter.nih.gov/project_info_description.cfm?aid=9347982&icde=45264746&ddparam=&ddvalue=&ddsub=&cr=5&csb=default&cs=ASC&pball=

This SBIR project will conduct research to address these two problems by building a computer system with (a) automated data feeds from multiple existing hospital computer systems and (b) advanced analytics to flag potential diversion for investigation. We will test the following four hypotheses: ● Data Consolidation hypotheses and experimentation plan: Phase 1: If we consolidate data from two systems (EMR & ADM), then we can detect diversion that would have been undetected using data only from the ADM (Hypothesis 1) Phase 2: If we consolidate data from five systems (EMR, ADM, Purchasing Systems, Internal Inventory System(s), and Employee Time Clocks) then we can detect diversion

that would have been undetected using only EMR & ADM data (Hypothesis 3) ● Data Analytics hypotheses and experimentation plan: Phase 1: If we create and test algorithms on blinded, consolidated, historical data from EMR/ADM, then we can detect known cases of drug diversion that that current methods do not detect, with fewer Type II errors (“false negatives”). (Hypothesis 2) Phase 2: If we refine and

test additional algorithms using near real-time, consolidated data from the five computer systems above, then we can detect drug diversion that current methods do not detect, faster, with fewer Type I errors (“false positives”) and fewer Type II errors. (Hypothesis 4)

Checklist

❑ I keep to the one-page limit.

❑ Each of my two or three aims is a narrowly focused, concrete

objective I can achieve during the grant.

❑ My text states how my work is innovative.

❑ I describe the business case to the extent needed for my

reviewers.

❑ I give a rationale for choosing the topic and approach.

❑ I tie the project to my preliminary data and other new

findings in the field.

❑ I explicitly state my hypothesis and why testing it is important.

❑ My aims can test my hypothesis and are logical.

❑ As much as possible, I use language that an educated

person without expertise can understand.

❑ My text has bullets, bolding, or headers so reviewers can

easily spot my aims (and other key items).

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https://www.niaid.nih.gov/grants-contracts/write-research-plan

Map Experiments and Money to

Your Aims

You should also document all of the resources and

facilities (e.g., access to clinical samples or specialized

reagents and animal models) available to you.

As you draft your budget, start a running tab of "who,

what, when, where, and how (much money)."

Who. A list of people who will help you for your Key

Personnel section later.

What. A list of equipment and supplies for the experiments you plan.

Time. Notes on how long each step takes. Timing directly

affects your budget as well as how many Specific Aims

you can realistically achieve.

Research usually takes longer than people think it will,

so design your research with that thought in mind.

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Feedback Loop

Specific Aims

Your Experiments

Budge and Personnel

Needs

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$225K Phase I,

$1.5M Phase II ≤

1. See if there are different experiments

that would meet your objectives

with the expertise at your disposal

2. Create new Specific Aims

https://www.niaid.nih.gov/grants-contracts/outline-your-experiments

Know Your Audience

Your scientific review group is the primary audience for your

application.

The primary reviewer presents your application's topic, strengths,

and weaknesses to the group, and other assigned reviewers may

comment.

They are chosen by the group's scientific review officer (SRO)—a

federal scientist—because their expertise is closest to your field.

You should not expect the other members of the study section to

be experts in your field or familiar with your science.

Your best strategy is to try to get as many people excited about

your project as you can. You'll do that by

Writing and organizing the entire application so your assigned reviewers can readily grasp what you propose and be well poised to explain it to everyone else.

Not neglecting the others by writing at a level they can understand.

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https://www.niaid.nih.gov/grants-contracts/know-your-audience

Criteria: Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?

Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project?

Have the investigators presented strategies to ensure a robust and unbiased

approach, as appropriate for the work proposed?

Are potential problems, alternative strategies, and benchmarks for success presented?

If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

For a Phase I application, are there clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II?

Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the

plans to address:

❖ The protection of human subjects from research risks, and

❖ Inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as

the inclusion or exclusion of individuals of all ages (including children and older adults), justified

in terms of the scientific goals and research strategy proposed?

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https://grants.nih.gov/grants/guide/rfa-files/rfa-da-20-018.html

Criteria: Approach (CT) Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required

study agent(s)? Does the application propose to use existing available resources, as applicable?

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https://grants.nih.gov/grants/guide/rfa-files/rfa-da-20-018.html

Criteria: Approach (CT) Data

Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions?

Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable?

Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed?

Is there a plan to complete data analysis within the proposed period of the award?

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https://grants.nih.gov/grants/guide/rfa-files/rfa-da-20-018.html

Preliminary Studies

Preliminary Studies (for new

applications).You can either

include this information as a

subsection of Approach or

integrate it into any or all of the

three main sections.

If you do the latter, be sure to mark

the information clearly, for

example, with a bold subhead.

Your preliminary studies show that

you can handle the methods and

interpret results. Here's where you

build reviewer confidence that you

are headed in the right direction by

pursuing research that builds on

your accomplishments.

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https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/format-attachments.htm

https://www.niaid.nih.gov/sites/default/files/1r44ai112187-01a1_coleman.pdf

Included all Relevant Data/Preliminary

Results (Even if not SUD specific) 21

https://projectreporter.nih.gov/project_info_description.cfm?aid=9000551&icde=45264808&ddparam=&ddvalue=&

ddsub=&cr=7&csb=default&cs=ASC&pball=

https://www.emocha.com/product

Case Study: Emocha

Graphics and Video

For applications, a picture can truly be worth a thousand words. Graphics

can illustrate complex information in a small space and add visual interest to

your application.

Look at our sample applications to see how the investigators included

schematics, tables, illustrations, graphs, and other types of graphics to

enhance their applications.

Consider adding a timetable or flowchart to illustrate your experimental plan,

including decision trees with alternative experimental pathways to help your

reviewers understand your plans.

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https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/format-attachments.htm

Check Point❑ I include enough background and preliminary data to give reviewers the context

and significance of my plans.❑ Each of my Specific Aims results in a set of experiments.

❑ They can test the hypothesis (or hypotheses).❑ I show alternative experiments and approaches in case I get negative or

surprising results.❑ My experiments can yield meaningful data to test my hypothesis (or hypotheses).❑ As a new investigator, I include enough detail to convince reviewers I understand

and can handle a method. I reviewed the sample applications to see how much detail to use.

❑ It is clear what I do well and what unique skills I and my team bring to the research. If I think reviewers may have doubts, I explicitly state my team's resources and expertise.

❑ If I or my team has experience with a method, I cite it; otherwise I include enough details to convince reviewers we can handle it.

❑ I describe the results I anticipate and their implications.❑ I omit all information not needed to state my case.❑ I keep track of and explain who will do what, what they will

do, when and where they will do it, how long it will take, and how much money it will cost.

❑ My timeline shows when I expect to complete my aims.

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https://grants.nih.gov/grants/guide/rfa-files/rfa-da-20-018.html

Informational Webinars to break

down the application process24

1. Social Determinants RFA: Writing a good Commercialization Plan Tuesday July 2, 2019, 2-4PM EDT https://nih.webex.com/nih/j.php?MTID=m9b22449a851e9c695cba34a55

81a2969

Contact us!

nidasbir@mail.nih.gov

1. What problem you are trying to solve?

2. How is it solved today?

3. What are you trying to achieve? (no terminology, please!)

4. Who is your customer? Are they willing to pay? Are they

easy to find?

5. What is new about your approach?

6. If you succeed, what difference do you think it will make?

7. How long do you think it will take?

8. How much will it cost? To develop? To produce? To use?

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