# Presentation: 177385

##  Grant Writing “Now that you have the K it’s not too early to think about getting grants”

**Frances R. Levin, MD****Kennedy-Leavy Professor of Clinical Psychiatry**** **

**Columbia University**
**College of Physicians and Surgeons**

** ****Grant Writing ****“Now that you have the K it’s not too early to think about getting grants”**

## My Experience

**Started working in the Division on Substance Abuse at Columbia University in 1992- Covering a lot of scientists’ studies**
**Strong interest in education, wasn’t trained to write grants but had an interest in clinical research **
**Obtained an SDAC- Scientist Development Award for Clinicians in 1994 **
- Began with pilot studies- Developed my niche
- Collaborated with individuals with expertise in behavioral pharmacology
- Carried out “side” projects from ongoing research
- Began writing RO1’s in my third year
- Got independent funding in my fifth year

## My Experience (cont’d)

**Applied for a KO2 and was funded in 2000 **
**In 2003, became the PI of the T32 substance abuse research fellowship at Columbia University**
**Applied for a competing renewal and was funded in 2005 until 2010**
**Focus for all these years has been on treatment of substance abuse and psychiatric comorbidity and education**

## While you have a K: What advice can I give you?

**Try to stick to the training plan as much as possible**
- It is very hard later on to get the training as outlined in your training plan
- My experience:  Difficulty following through with the coursework. 3 Children under the age of 5, grant writing, administrative work, desire to pursue educational initiatives in the Division
- Hard choices: Probably do the same thing, maybe

## While you have the K: What advice can I give you? (cont’d)

**There will be many competing interests**
- Private practice
- Requests to see patients in clinic settings
- Requests to handle administrative tasks
- Requests to provide teaching
- Difficulty scaling back on responsibilities you were previously carrying on others’ (often your mentors’) projects (who will take over for you?)
**What is the answer: **
- Balance and do what you enjoy most

## What advice can I give you? (cont’d)

**Have to think of several things simultaneously**
- Progressing academically within your institution as well as being able to obtain independent funding and progress within the K mechanism
- If you are pursuing a scientific track
- Need to have enough peer-reviewed papers
- Need to obtain independent funding
- Need to provide teaching
- Need to be a team player within your department
- Agree to be on committees (IRB, faculty council)

## Certain Realities

**Five years seems like a long time - you “blink” and it’s over**
**Need to Write Often- It’s part of the game**
- First author reviews and chapters are good but don’t let them stand in the way of an empirical paper. Don’t jump into a review/chapter in which you are a co-author unless it won’t involve a lot of work or interfere with other papers
- If you have writer’s block- “get over it”
- Don’t be afraid of criticism. A manuscript “dipped” in red ink is OK
- Your mentor(s) should be helping you get first authored papers
- Problems can arise with mentors who are too junior and need first authored papers for themselves

## What are the critical tasks of the K Award?

**Learning what you are supposed to learn**
- Make sure you are taking advantage of your mentors
**Focus on collecting data**
**Writing papers**
**Writing grants**
- Get R01’s! (this is the sine qua non for K renewal)

## Preparing to Write that First RO1

**Preparing to Write that First RO****1**

**Remember why you were awarded a F or K in the first place--to protect time so that you can gain valuable experience to prepare you for a career as an independent scientist.**
**If you complete your training without publishing the results, then the reviewers’ enthusiasm for your RO1 application will be significantly “dampened.”**

## Preparing to Write that First RO1 (cont’d)

**Preparing to Write that First RO****1**** **(cont’d)

**If it has not been published, then you did not do it!**
**Avoid filling your CV with a bunch of abstracts or posters in lieu of peer-reviewed publications. This suggests that either you are unfocused or cannot finish a project.**
**Alternatively, if you convert abstracts to papers, then you show good promise**.

## Preparing to Write that First RO1 (cont’d)

**Preparing to Write that First RO1**** **(cont’d)

**Avoid using the words “in preparation”--the universe is in preparation.**
**Awards involving clinical or long-term studies need to be creative to ensure productivity along the way....**
**Need to identify smaller components that make contributions to the field and warrant publication.**

## Preparing to Write RO1’s (cont’d)

**When grants are reviewed they will evaluate your productivity: Do you finish what you start? Do abstracts turn into papers?**
**Cannot expect that grants will be funded or even scored on the first review- therefore have to submit often but don’t start too early. End of third year, beginning of 4****th**** year good time to start.**
**If you get independent RO1 or Center Project Funding as a PI you will be able to get a K02 or another mid-career K award. That is one path but not the only one.**
**Don’t worry too much if the grant (R01) is not in the same area as the K.  The K implies growth and branching out.  The most important thing is an R01, any R01.**
- You can always spin how your new R01 connects to your K

## Concept Development-RO1

**Concept Development-RO1**

**What should you write about?**
**	****Questions:**
- what is not known about a topic?
- what new information will be learned?
- why is it important?
- how will it be applied?
- will your project fill any gaps in the literature?
**SPEAK TO NIDA PROGRAM STAFF!**** **

## Concept Development-RO1 (cont’d) 

**Concept Development-RO1**** **(cont’d)

**Focus:**
**Contrary to popular belief, your research focus should be narrow, not broad-based.**
**Begin to think about a specific area of research within a field.**
**Avoid making grandiose statements about the direction of the field and how your proposal will change it all...**

**Concept Development-RO1**** **(cont’d)

**Focus**:
**Avoid the appearance of a “fishing expedition.”**
**To do this, try to limit your proposal to **_**3**_** primary hypotheses.**
**Avoid the temptation to get around this by adding multiple “secondary hypotheses.**”

## Writing Tips

**Writing Tips**

**Title:****	****The title is the FIRST thing that reviewers will see so be creative and grab their interest. **

**Abstract:****	****This must give an overview of all key elements in the proposal. It is a mini application and should note the importance, background and goals of the research. It is archived in NIH databases separate from your proposal (CRISP).**

## Writing Tips (cont’d)

**Writing Tips **(cont’d)

**Specific Aims****:**** ***** ***
**Summary of proposal and goals. **
**Typically, complete this in 1 page or less. **
**State the hypotheses to be tested and how the various phases of the study fit together, especially if there are both short- and long-term goals. **
**If you are responding to an RFA, then state the mechanism and how your application fits.**

## Writing Tips (cont’d)

**Start off by writing 5-6 Specific Aims. ****(you can delete some later)**
**Enlist the aid of 2-3 more experienced investigators to review your Aims and help you! Revise your Aims and get additional feedback.**

- FOCUS

## Writing Tips (cont’d)

**Writing Tips**** **(cont’d)

**Background & Significance****:**** ***** ***
**A***** *****succinct, scholarly and persuasive dialogue that ends with ****why**** the work should be done. **
**Point out the theoretical importance of your proposed research plan and end with how your research will move the field forward. **
**Plan to allocate 3-5 pages for this section**.

**Hot**** **“TIP” #1:  Review _only_ most important literature; do not cite every paper written on the topic!

## Writing Tips (cont’d)

**Preliminary Studies****:***** ***
**Present real data (in graphic or tabular format) that describes the relevance to your application with the aim of showing that you have the required expertise to carry out the proposed studies. **
**This is where PILOT DATA becomes very important as it demonstrates the feasibility of the study. When possible, try to use the same instrumentation that you propose to use in the application.  **

## Writing Tips (cont’d)

**Preliminary Studies****:**** ***** ***
**Pilot data can be a few subjects, and if used properly, can convince the reviewers that the proposed studies are *****feasible*****.**
** ****Often, this section can be filled with your prior research findings, but other relevant experience or studies conducted by your co-investigators can be included. **
**  **

## Writing Tips (cont’d)

**A lack of Pilot Data [in an RO1 application] is likely to be a fatal flaw, especially for young investigators.  IF you do not have any Pilot Data, then consider using a different mechanism such as a RO3, R21, etc.**

## Writing Tips (cont’d)

**Preliminary Studies****: ***** ***
**If you cannot read the graph, then there is no reason to put it in your application.**

## Writing Tips (cont’d)

**Design & Methods****: **
**Introduction-why do the experiment in this particular way?**
**Hypotheses-be clear and concise**
**Subjects-describe in sufficient detail**
**Design-use diagrams when possible**
**Procedures-explain variations, cite standards**
**It is also important to explain why you chose a particular method or strategy.**

## Writing Tips (cont’d)

**Design & Methods****: **
**Data analysis-include statistical plan as well as a power analyses to justify the N.**
**Summary-restate the importance of experiment and future directions of the research should the experiments be successful.**

## Writing Tips (cont’d)

**Design & Methods:**** ***** ***
**Address potential problems and solutions (if you have any), but be careful that you do not offer up potential problems and no solutions or contingency plans or alternatives--the reviewers will see this as a weakness in your Approach.**

**Hot**** **“TIP” #2: Provide rationales throughout as to why certain methods were selected and why key alternatives were not

## Writing Tips (cont’d)

**Writing Tips **(cont’d)

**Timeline****: **
**A realistic and well-planned estimate of start/ end times for each experiment. DO NOT just stick experiment #1 in year 1 and experiment #2 in year 2, etc... Make sure that this matches your budget, % effort and requested FTEs**

## Writing Tips (cont’d)

**Human/Animal Subjects****:**** **
**Allows you to address women, minorities and children/ adolescent subjects--not included in the 25 page limit.**

**Hot**** **“TIP” #4:  Abide by the page limitation and the minimum font—Reviewers are not happy if you try to get around it!

*Note on distributions*: The % of women/minorities relates to the percent of the population that have the disease or problem being studied, not the % that is available in your home town!

## Supporting Material

**Budget Justification****:**
**Allows you to explain how you will use the funds as well as define the role of key personnel. However, with *****Just In Time***** guidelines, detailed information is not typically requested until you pass the initial review (or if you are requesting more that $250K per year, direct costs).**

## Supporting Material (cont’d)

**Biosketches:**** **
**Make sure that these are current. **
**It is bad form to include the biosketch of a senior co-investigator and his/her last publication is listed as 1997--CHECK THAT THEY ARE ACCURATE AND CURRENT**

## Supporting Material (cont’d)

**This section should provide enough detail to assess how unique the present proposal is and whether there is any scientific or budgetary overlap with other projects. **
**If there is overlap, simply state it and note what adjustments would be made should an award be made. **
**Double check the Percent Effort to ensure that key personnel are not over committed.**

**Supporting Material **(cont’d)

## Supporting Material (cont’d)

**Reviewers are only allowed to evaluate the material that is in the application, even if they have first hand information to the contrary! So, be sure to include all pertinent data that helps them review your application.**

**Supporting Material **(cont’d)

## Supporting Material (cont’d)

**Allows you to describe the key facilities available to you and/or where the research is to be conducted. **
**If you are collaborating with another scientist, make sure that his/her information is also included. **
**Also, describe the key equipment/instruments that are available to you, and which items are not. This is very important if you are requesting funds for equipment.**

**Supporting Material **(cont’d)

## Supporting Material (cont’d)

**Make sure that you have letters of commitment from the lab directors or service chiefs indicating that you have access to the resources that you describe.  **
**If you are recruiting a clinical population, have the letter state how many potential subjects will be made available to you and over what time period. This will address the issue of feasibility.**

**Supporting Material **(cont’d)

## Overall Strategy to Tackling the Application

**Once your aims are set, arrange your Preliminary data to support these aims. ****Sometimes work that you have done in other labs can be used to demonstrate feasibility.**
**Write your Methods section next.  ****Be sure to follow your Specific Aims!**
**Justify your selection of specific methods if there are multiple strategies that could be used.****  ****It is never wise to “trash” another method in favor of the one you have selected--you just never know what method your *****REVIEWER***** uses!!!!**

## Overall Strategy to Tackling the Application  (cont’d)

**Write your Background and Significance Section next. ****Now that you have your aims and experiments finalized, you can focus on setting up the rationale for conducting the study. Note that you will have a good idea of this section--just not written yet.**
**Write your Abstract next.  ****It is wise to use your Specific Aims as a template here to avoid any inconsistency. *****Also, the abstract is the one item that nearly every reviewer in the room will read!***
**Write your title LAST! ****This can be more meaningful now that the entire scope of the project is well defined.**

## Successful Writing Strategies 

**Successful Writing Strategies **

**Audience****: remember who is reading your application--these are VERY busy people, so make it easy for them to follow your rationale, logic, planning, methods, analysis and thinking.**
**Reviewers**** are looking to see if you can THINK through a problem and assign *****strengths***** and *****weaknesses***** to each aspect of the review criteria.**

## Successful Writing Strategies (cont’d)

**Successful Writing Strategies **(cont’d)

**Repetition****: repeat significance and what will be learned at the end of experiment.**
**KOD*****: wonderfully elaborate and detailed methods, techniques and procedures are worthless if you do not convince the reviewer that the study is worth doing in the first place!**
- 	*** Kiss of Death**

## Successful Writing Strategies (cont’d)

**Power of suggestion:**** highlight the strengths of your proposal wherever you can.**
**Humility:**** it is far better to identify weaknesses and explain how you will deal with them than it is to “hope” that the reviewer will not find them--they usually do!**

**Hot** “Tip” #7:  Use **Bold**, *italics or *_*underline*_* *judiciously to emphasize key points and to help with the organization—BUT do not overdo it!

## Hot  “TIP” #8: Pay attention to details--organization, spelling and grammatical errors question the care that you used to put the rest of the application together.

**Common Pitfalls**

## Common Pitfalls (cont’d)

**Common Pitfalls **(cont’d)

**Common Problems**
- Investigator
- Lacks sufficient expertise
- Lacks skilled collaborators
- Lacks demonstrated “tract record”
- Mediocre publication record
- (your K-Award is supported to fix these issues...)

## Common Pitfalls (cont’d)

- Studies lack cohesiveness
- sequence of experiments is not logical
- results of a study lead to a dead end
- subsequent studies rely too much on previous experiment(s)
- contingency plans either not stated or ill conceived and are not feasible

**Hot**** **“TIP” #10:  Do your homework and make sure that no one has already done your study.

**Common Pitfalls **(cont’d)

## Common Pitfalls (cont’d)

**Common Problem**
- Design Flaws
- Insufficient statistical power
- Imprecise measure (dependent variables)
- Cannot recruit the needed population
- Lack of face validity
- You pick the wrong technique
- Missing or wrong control group

## Hot “TIP” #11:  Discuss your ideas with NIDA Staff as they can help direct your efforts to improve the quality of your proposal.

**Common Pitfalls **(cont’d)

## Amended Applications - A1

***READ the***** review very carefully and then put it away for a day or so.**
**If you did not receive a score, then there will not be a summary of the discussion.**
**An *****Unscored***** application means that it was in the bottom half of that particular round of applications.**

**Amended Applications - A1**

## Amended Applications -A1 (cont’d)

- Allows you to address the previous review--use these 3 pages *wisely*
- Throw out your first response to the reviewers
- Be sure to address ALL comments/concerns in the Introduction
- Use the same terminology as the reviewer[s]
- Avoid confrontation
- Avoid becoming defensive
- Highlight the major changes in the application

**Amended Applications -A1 **(cont’d)

## Amended Applications -A1 (cont’d)

- attack the Reviewer’s intentions
- rush to get it out by the next submission cycle
- add substantial NEW information or new studies
- overreact and take comments personally
- point out the reviewers’ weaknesses
- write a rebuttal that is longer than the critique
- dwell on a reviewer’s error--make the point and move on with your response

**Hot** “TIP” #12:  Ask a colleague to read your application (as a reviewer, not as a friend)

**Amended Applications -A1 **(cont’d)

## Amended Applications -A1 (cont’d)

**Amended Applications -A1 **(cont’d)

**Simply have the resolve to send your application back until the Study Section gets it right!**

## Some Recommendations

**Try to keep clinical applications below $249,000 per year, direct costs. **
**However, imaging studies are typically more costly.**
**Aim for 3 years of support; it is tough for reviewers to be convinced that 5 years of support is justified for an untested junior scientist. The budget on an RO1 is scrutinized very carefully. **

**Some Recommendations**

## Some Recommendations (cont’d)

**It is helpful to make out a “duty sheet” to ensure that all aspects of the research are covered.**
**Make sure that your research team has seen the application and that they have provided you with feedback. **
**This means that you cannot give them the application to read on June 30 for a July 5 receipt date...**

**Some Recommendations **(cont’d)

## Some Recommendations (cont’d)

**Be persistent in reaching your goal. The success rates for first time applications are low. **
**Do not send off your grant and then sit around in the lab waiting for the results to come back--find other ways to collect the pilot data, foster your collaborative relationships and write scientific papers.**

**Some Recommendations **(cont’d)

## Some Recommendations (cont’d) 

**Get more than one iron in the fire**
- Any one grant application has a limited chance of funding
**Send out multiple grants in different, though related areas**
**Package the same grant (with variations) toward multiple different funding mechanisms (different institutes, mechanisms, foundations)**
- The ”Buckshot” approach
**Again, don’t worry if your grants don’t line up neatly with your K focus.  The key is to get independent funding. **

## Certain Realities (cont’d)

**Be nice. Be respectful. Make friends. Help others.**
- You never know who will be reviewing your grants and papers
**Develop Collaborations**
- Will give you a way to expand into new areas
- Will demonstrate your ability to be flexible and creative
- Will increase your productivity

## Certain Realities 

**Develop your own niche(s)**
- Area of expertise and accomplishment that your name becomes attached to
- You want to become “the world’s greatest expert” in something
- Look for new areas, where not a lot of others are working
- May be a “messy” or intimidating area that others have shied away from
- May be a new, emerging clinical problem
- May be something that’s been overlooked
- Look for an area where there is promise of funding
- Look at NIH Program Announcements (PA) and Requests for Applications (RFAs)!

## Certain Realities (cont’d)

**Dirty Secret:  Salary support is critical. You cannot succeed in academics if you do not figure out a way to get your salary covered. Institutions will only provide limited unfettered support. **
- If  you do not have research support you will need to take on administrative or clinical duties or run someone else’s research
- Find out how other people in your institution, at your level, doing what you do, are getting funded

## Career Planning

**Plan to obtain no more than 50-60% of your salary from your first RO1--so from where does the rest come?**
**Consider building collaborations now and have small percentages of salary on other grants.**

**Career Planning**

## Career Planning (cont’d)

**It is never too early to begin to think about such collaborations as they will help define you as a scientist and increase your chances of receiving an outstanding score. **
**Once you obtain an independent RO1, another possibility is obtaining a mid-career K award.**

**Career Planning **(cont’d)

## Career Planning Beyond Writing RO1s (But May Indirectly Help You)

**Get yourself known- Networking is important**
- Go to meetings
- Introduce yourself to senior individuals at meetings in your area of interest
- Present your data- Best if you can give talks
- Learn how to give talks
- Watch the “masters” give talks
- Practice and then make it look effortless- have a sense of humor

## Mentoring the Next Generation

**Avoid taking on too many students or postdocs too soon.**
**You owe it to yourself (and your future students) to become firmly established as a researcher **_***before***_** you try to support others.**

**Mentoring the Next Generation**

## Parting Thoughts

**Do other things you enjoy!**

**Parting Thoughts**

## Federal Support (Dr. Levin)

**NIDA Support**
- K02 DA00465 -*Treatment of Substance Abuse and Psychiatric Comorbidity*
- RO1 DA015451 -*Marijuana Dependence & Depression: Venlafaxine Treatment*
- T32 DA007294 -*Research Fellowship in Substance Abuse Disorders*
- P50 DA09236 (Project 4/Center Grant) - *Agonist Treatment for Marijuana Dependence*
- R01 DA022217 –* Combined Pharmacotherapies for Cocaine Dependence*
- R01 DA023652  - *Extended Release Mixed Amphetamine Salts for Adult ADHD and Cocaine Dependence *