Grant Writing Now that you have the K its not too early to think about getting grants

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Grant Writing Now that you have the K its not
too early to think about getting grants
Frances R. Levin, MDKennedy-Leavy Professor of
Clinical Psychiatry
Columbia University College of Physicians and
Surgeons
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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, wasnt 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 RO1s in my third year
• Got independent funding in my fifth year

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My Experience (contd)

• 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

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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

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While you have the K What advice can I give
you? (contd)

• 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

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What advice can I give you? (contd)

• 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)

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Certain Realities

• Five years seems like a long time - you blink
  and its over
• Need to Write Often- Its part of the game
• First author reviews and chapters are good but
  dont let them stand in the way of an empirical
  paper. Dont jump into a review/chapter in which
  you are a co-author unless it wont involve a lot
  of work or interfere with other papers
• If you have writers block- get over it
• Dont 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

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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 R01s! (this is the sine qua non for K
  renewal)

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Preparing to Write that First RO1

• 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.

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Preparing to Write that First RO1 (contd)

• 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.

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Preparing to Write that First RO1 (contd)

• 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.

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Preparing to Write RO1s (contd)

• 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 dont start too early. End of
  third year, beginning of 4th 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.
• Dont 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

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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!

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Concept Development-RO1 (contd)

• 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

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Concept Development-RO1 (contd)

• 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.

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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).
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Writing Tips (contd)

• 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.

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Writing Tips (contd)

• 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
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Writing Tips (contd)

• 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!

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Writing Tips (contd)

• 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.

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Writing Tips (contd)

• 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.

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Writing Tips (contd)
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.
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Writing Tips (contd)

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

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Writing Tips (contd)

• 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.

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Writing Tips (contd)

• 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.

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Writing Tips (contd)

• 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

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Writing Tips (contd)

• 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

• Hot TIP 3 Overly Ambitious is a frequent
  flaw of most young grant writers

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Writing Tips (contd)

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

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!

• Hot TIP 4 Abide by the page limitation and
  the minimum fontReviewers are not happy if you
  try to get around it!

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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).

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Supporting Material (contd)

• 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

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Supporting Material (contd)

• Other Support
• 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.

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Supporting Material (contd)

• REMEMBER THIS
• 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.

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Supporting Material (contd)

• Resources Environment
• 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.

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Supporting Material (contd)

• Resources Environment
• 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.

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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!!!!

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Overall Strategy to Tackling the Application
(contd)

• 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.

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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.

• Hot TIP 5 Include basic information where
  necessary. Only a few of the reviewers will be
  EXPERTS in all aspects of your application.

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Successful Writing Strategies (contd)

• 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

• Hot TIP 6 High tech is no substitute for
  solid logical planning.

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Successful Writing Strategies (contd)

• 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 organizationBUT do not overdo it!

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Common Pitfalls

• 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.

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Common Pitfalls (contd)

• 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)

• Hot TIP 9 If you engage in collaboration,
  then let the collaborator READ the application
  before you send it.

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Common Pitfalls (contd)

• Common problems
• 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.

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Common Pitfalls (contd)

• 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

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Common Pitfalls (contd)

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

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Amended Applications - A1

• Implications
• 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.

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Amended Applications -A1 (contd)

• Strategies for resubmission--the Introduction
• 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 reviewers
• Avoid confrontation
• Avoid becoming defensive
• Highlight the major changes in the application

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Amended Applications -A1 (contd)

• Do not do these things
• attack the Reviewers 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 reviewers 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)

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Amended Applications -A1 (contd)

• Remember that Amended Applications are a way of
  life--everyone has to deal with them at some
  point.

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

• Try to keep preclinical (rats mice)
  applications below 150,000 per year, direct
  costs.
• 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.

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Some Recommendations (contd)

• Assemble your team of collaborators very
  carefully and make sure that the expertise that
  is needed for the project is represented.
• 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

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Some Recommendations (contd)

• You are now required to identify the study
  section in the electronic application
  process--Choose carefully and look over their
  charge and members.
• 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.

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Some Recommendations (contd)

• 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, dont worry if your grants dont line up
  neatly with your K focus. The key is to get
  independent funding.

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Certain Realities (contd)

• 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

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Certain Realities

• Develop your own niche(s)
• Area of expertise and accomplishment that your
  name becomes attached to
• You want to become the worlds 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 thats been overlooked
• Look for an area where there is promise of
  funding
• Look at NIH Program Announcements (PA) and
  Requests for Applications (RFAs)!

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Certain Realities (contd)

• 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 elses research
• Find out how other people in your institution, at
  your level, doing what you do, are getting funded

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Career Planning

• Early careers are a hybrid of various types of
  grants, with your role ranging from PI to
  collaborator. It is tough to get 100 of your
  support from a single RO1 grant.
• 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.

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Career Planning (contd)

• For example, you can be a co-investigator on 2-3
  other grants with 10-25 effort on each to make
  up the difference from your RO1.
• 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.

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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

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Mentoring the Next Generation

• Once you have independent funding, you will be in
  a position to serve as a mentor.
• 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.

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Parting Thoughts
Do not simply propose something that you think
has a good shot at getting funded because there
is a RFA out. There is nothing worse than working
on a project (for 3-5 YEARS) that does not truly
excite you. Make sure that you will ENJOY
conducting the research that you propose. Do
other things you enjoy!
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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