Archive for the ‘medical writer’ Tag

New Webinar: “Mistakes Commonly Made on NIH Grant Applications”

In an effort to provide cost-effective training to the broadest group possible, I am launching a series of webinars in the upcoming months. The first of these will be in early February, and the goal will be to help grantees recognize and correct common submission mistakes.

Unlike many who conduct NIH submission training programs, I myself work on NIH submissions full time. I see clients make the same types of mistakes repeatedly– mistakes that are easily avoided.

Each year I am fortunate to have dozens of clients share their Summary Statements with me. Because I regularly read reviewer comments from a multitude of study sections, I can easily identify trends in pink sheets. I also keep track of evolving trends at NIH based on information I find in FOAs, Notices, and Appropriations Testimony. Study sections change, funding priorities evolve. It is important to understand NIH’s priorities right now.

I have helped clients land over $200 million in federal funds in the past five years. Your NIH submission will entail several hundred hours of work by you and others. Why not learn strategies to optimize your success on this and future submissions?

What: Webinar entitled “Mistakes Commonly Made on NIH Grant Applications

Who: Ideal for faculty preparing to submit a K, R21, R03, or R01 in an upcoming cycle, and the senior faculty and administrators who advise them.

When:Wednesday 4 February 2015, 11am-12:30pm EST or
Thursday 12 February 2015, 11am-12:30pm EST
Cost: $149
Takeaways: At the end of this 90-minute session, participants will be able to:
1) Predict some key criticisms reviewers may make
2) Identify problems in their or their colleague’s draft applications
3) Utilize that information to write stronger drafts


NIH Grantwriting Webinar Series Begins in February 2015!

We are happy to announce that in addition to one-on-one consulting, workshops, and seminars, we are now adding webinars to our menu of options to help NIH grantees. Upcoming webinars:

Mistakes Commonly Made On NIH Grant Applications
Benefit from the knowledge gained by a grantwriter who reads dozens of Summary Statements per year.

Wednesday 4 February, 11am-12:30pm EST or Thursday 12 February, 11am-12:30pm EST

NIH Submission Strategies
Take steps to optimize your chance of success before you write.

Wednesday 11 February, 11am-12:30pm EST or Thursday 19 February, 11am-12:30pm EST

How To Write The Specific Aims Of An NIH R01
Learn how to make the most important section of your submission compelling and persuasive.

Wednesday 25 February, 11am-12:30pm EST or Tuesday 3 March, 11am-12:30pm EST

Learn More!

Marijuana Is More Damaging Than You Might Have Thought

Credit: Paul at

Credit: Paul at

Because there is a nationwide move to legalize (or at least decriminalize) pot, there are a lot more studies on   it now. Older studies are not always relevant because there is so much more THC in today’s pot. The National Institute on Drug Abuse (NIDA) just issued a press release about findings reported in a New England  Journal of Medicine article.

Among the not surprising findings: it’s addictive, it impairs driving, and like alcohol and nicotine it’s a gate- way drug. More surprising: using marijuana as a teenager is more damaging than using it as an adult, probably because the brain is not fully formed until one’s early twenties. The damage to memory and cognition  are more pronounced when used by teens. Using it in your early teens permanently decreases one’s adult IQ, even if you don’t smoke as an adult. Another surprising finding: All users have impaired thought and memory while high, but regardless of age, the deficits actually last for days afterward. An estimated 6.5% of 12th-graders nationwide report daily pot smoking, and 60% do not perceive it as dangerous.


Seeing Beauty in Biology

Meg- Microscope Pic

Credit: Lemonade at

I started my career in a laboratory, spending countless happy hours doing cell culture work and bent over a microscope. I sometimes miss those quiet hours and the joy of doing delicate, precise work with my hands. I also miss the beautiful images under the microscope, especially of neurons. So it’s no wonder that the winning entry of the 2013 Visual Challenge knocked my socks off. Each year Science magazine and the National Science Foundation conduct an International Science & Engineering Visualization Challenge. The 2013 winners in each category were announced last month, and can be found here (

This year’s winners in the Illustration category were Greg Dunn and Brian Edwards, Greg Dunn Design, Philadelphia, Pennsylvania; Marty Saggese, Society for Neuroscience, Washington, D.C.; Tracy Bale, University of Pennsylvania, Philadelphia; Rick Huganir, Johns Hopkins University, Baltimore, Maryland

The winning entry in the Illustration category looks like Asian art—beautiful cortical neurons displayed like bare trees in winter, against a pastel background in muted tones. The Science magazine piece describes it thus:

Cortex in Metallic Pastels represents a stylized section of the cerebral cortex, in which axons, dendrites, and other features create a scene reminiscent of a copse of silver birch at twilight. An accurate depiction of a slice of cerebral cortex would be a confusing mess, Dunn says, so he thins out the forest of cells, revealing the delicate branching structure of each neuron.

“Dunn blows pigments across the canvas to create the neurons and highlights some of them in gold leaf and palladium… He hopes that lay viewers will see how the branching structures of neurons mirror so many other natural structures, from river deltas to the roots of a tree.”

This idea about the repetition of such visual themes throughout nature is bound to resonate with any biologist who has spent time at a microscope. I have been enjoying watching the remake of the wonderful television series Cosmos, and I must say that the images they show of space remind me strongly of many of the images I saw years ago at the microscope.

Not surprisingly, Greg Dunn earned a Ph.D. in neuroscience and loves Asian art.  His works can be seen and purchased here (

(And no, I have no financial interest in recommending Dr. Dunn’s art work—though I may buy a print for my office!)

Bioart Winners

When I was a bench scientist, I had the joy of working with a lot of visual data. It was one of the great pleasures of my work back then. So even though we are flat out busy with work this week as we approach the new R01 deadline on October 5, I am taking a quick break to share some memorable bioart with you.


Of the 12 winners of FASEB’s 2013 Bioart contest, 11 received NIH funding. The NIH Director will begin showcasing their work through a series entitled, “Snapshots of Life.” Take a moment out of your busy day to enjoy beauty of the natural world at a level rarely seen in our daily lives. Who knew that schistosomiasis could be so breathtakingly gorgeous? :



Adaptive Clinical Trials Using Bayesian Inference and Decision Theory

I recently returned from Phoenix where I summarized a consensus conference on Comparative Effectiveness Research (CER). The conference was sponsored by the American College of Sports Medicine (ACSM), one of my favorite clients.  Among other things, the conference focused on the idea that unlike randomized control trials (RCTs), long considered the gold standard in clinical research, factorial designs allow you to construct adaptive interventions. As I understand it, at the heart of these study designs are a form of game theory and bayesian modeling. I know little on either topic so I asked my colleagues from the American Medical Writers Association what they knew.

One of my AMWA colleagues let me know that Bayesian methods have the potential to significantly reduce sample sizes, and therefore research costs. Game theory isn’t used all that much for adaptive clinical trials except in the form of statistical decision theory. A list of references on Bayesian inference and decision theory is provided at the bottom of this blog post (thanks to my AMWA colleague Robert Ryley).

Another AMWA member stated that within the medical device community people turn to Don and Scott Berry for information on adaptive clinical trial design. Check out Berry Consultants website. Another trusted AMWA colleague pointed me toward a recent NPR article, in which Stuart Kauffman states, “…when RCTs work, they do really work, often well. But they often fail in complex biological-medical situations where causality is multifactorial, as it typically is. In place of RCT, our group has found a better alternative in these cases which we call ‘Team Learning.’” Finally an AMWA member said that while she couldn’t comment on adaptive clinical trial design, she did know that game theory, particularly a form of “crowd sourcing”, is being used in the design of diagnostic algorithms.

The Patient-Centered Outcomes Research Institute (PCORI) will be awarding grants in CER through 2019. What are your thoughts on applications of Bayesian principles and decision theory to medical research?

Bayesian Inference and Decision Theory References-

Provided by Robert Ryley (rryley1976@GMAIL.COM)

Here is a list of decision theory references with a numerical ranking of the mathematical competence required to understand the text:

1. High School Level — elementary algebra or geometry at most
2. Undergraduate Level text — Multivariable calculus helpful. Basic calculus a must.
3. Advanced Undergraduate/Graduate Level Text —  Complex Analysis and Measure Theory presumed

Classic Texts
Title: Elementary Decision Theory
Initially Published: 1959
Authors:  Herman Chernoff, Lincoln Moses
Difficulty Rank: 1
Summary: A classic in decision theory that provides a very good introduction to basic frequentist statistics and their application to decision problems.   It has been kept in print by Dover publications and is very cheap compared to more modern texts.  One thing to keep in mind — the data analysis methods described here were for people who only had pencil and paper as an aid. Start here first if your understanding of basic undergraduate statistics is a bit rusty.

Title: Games and Decisions: Introduction and Critical Survey
Authors: R. Duncan Luce, Howard Raiffa
Initially Published: 1957
Difficulty Rank: 2
Summary: Provides more intuitive justifications for game theoretic reasoning.  The authors wrote the text to broaden the knowledge of these methods for social scientists.  Apparently, this text was used by John Nash when he taught an intro game theory course.  A more modern, and less mathematically oriented approach is also provided in the book Negotiation Analysis, which has Howard Raiffa as one of the co-authors.

Title: Theory of Games and Statistical Decisions
Authors: David Blackwell, M.A. Girshick
Initially Published: 1954
Difficulty Rank: 3
Summary: I believe this text was widely used in graduate-level statistics programs.  At the very least, it is widely cited in more modern statistics books.  It is probably overkill for most of us, but those who want to understand how statistical procedures are evaluated by experts will likely want to study this.  I have a copy lying around somewhere.  This has also been kept in print by Dover publications.

Modern Texts
Title: Statistical Decision Theory and Bayesian Analysis
Author: James O. Berger
Initially Published: 1985
Difficulty Rank: 3
Summary: A highly recommended graduate level text in statistical decision theory. Although it continues to be used in graduate-level statistics programs as far as I know, it could be followed by someone with college-level algebra and calculus who has persistence to work through the examples and look up what is unfamiliar.

Title: Bayesian Data Analysis: A Tutorial
Authors: D.S. Silva, John Skilling
Initially Published: 2006
Difficulty Rank: 3
Summary: This book was designed for undergraduates in science and engineering.  It encourages thinking in probabilistic terms and shows how to apply mathematical methods commonly used in engineering toward statistical problems.  Physicist and prominent Bayesian protagonist E.T. Jaynes recommended this book as a complement to his more theoretical book Probability Theory: The Logic of Science.

Title: Introduction to Applied Bayesian Statistics and Estimation for Social Scientists
Author: Scott M Lynch
Initially Published: 2007
Difficulty Rank: 2
Summary:  A very good intro for social scientists — psychology, sociology, etc.  The author provides some basic methods from calculus and matrix algebra for those who are lacking in this area.  It will certainly help you bridge the gap from conventional frequentist methods toward a Bayesian way of thinking about problems.

Title: Bayesian Adaptive Methods for Clinical Trials
Author: Scott M Berry
Initially Published: 2010
Difficulty Rank: N/A
Summary: I have not purchased this book, but it is certainly on my wish list.

Purposeful porpoising: Working smart when you gotta work hard

This blog post about being an overwhelmed freelancer really hit home for me:

Purposeful porpoising: Working smart when you gotta work hard.

TOP TEN TIPS for Writing an NIH Center Grant Application

We just staggered over the finish line of another massive NIH grant application. These monster applications exact their toll on everyone, always leaving the entire team feeling completely drained. Having now been involved in developing a number of large-format NIH grant applications (P-series and U-series), I have begun to compile a list of things that go into making not just a successful application, but a good experience for everyone:


1. It takes a village. Or rather, a small city. Trite I know, but let me tell you, these applications will demand the availability and input of dozens of people. In addition to the PIs, the grant application writers will need unfettered access to the myriad investigators involved in the project (including co-Is, PIs on subcontracts, consultants, etc.) as well as budget people, grant administrators, hospital/university administrators, policy wonks, etc. I once needed eleventh-hour input from a team of upper-level administrators from a major medical center who were all traveling to the same conference; They teleconferenced in to me from an airport terminal in the eight minutes it took for them to be called to board their flight. All hands on deck. Kiss your families goodbye. Everyone hand over your off-hours contact info.


2. Within that village there must be one Chief. And that point person must be willing to seriously put him/herself in the red zone for the application. S/he will be at least as sleep-deprived as we are by submission. I have worked on center grant applications where there was a single point person who was willing to turn him/herself inside out for the application, a person who was available 24/7 if I had questions, someone who was willing to jump into the fray and resolve any and all issues that might arise. This person is involved in every aspect of the project from concept development, strategic planning, and kick-off meeting to final manuscript review. This person reviews every word of every draft of every section of the application, and does not sign off until someone hits the “Upload” button to the portal (or you hear the engine fade as the FedEx truck drives off with your paper submission.) In contrast, I have been involved in center grant applications where no one assumes this responsibility. Guess which applications fare better? My take-home message here is to upper-level administration: If you want to improve your odds of landing a center grant, choose a capable person (often one of the PIs, but not always) and free up that person’s schedule for a few months so s/he can dedicate him/herself to the task. Yes, really.


3. Kids don’t try this at home. Hire yourself a full-service team to develop the grant application. These large-format grants tend to start at around $8-$10 million, and go up from there. Beyond the dollar award, the benefits of landing such a prestigious award are numerous and not always tangible or quantifiable. If you are serious about improving your odds of funding, invest up front in a skilled and experienced team to help you navigate the process. On that team one should have several experienced and highly-skilled writers, a dedicated budget person, and a project coordinator who will help run teleconferences, create timelines, organize support letters, etc. The project coordinator also can help on the other end with formatting, pagination, and uploading (believe me, this part takes a lot longer than you ever think, especially for these gigantic applications. The devil is in the details.)


4. Plan the project well in advance. Projects work best if you can identify an FOA, assemble a team, and meet to brainstorm and strategize about how to proceed. I have posted previously about my feeling that center grant applications work best when the host institution invests significant money beforehand to launch some of the projects/cores that will go into the application. That sort of up-front investment goes a long way toward showing reviewers that the projects are feasible and also demonstrates a high level of commitment on the part of the institution.


5. Recognize that most groups don’t plan well in advance. Apply anyway.  Very few center grant applications are written under ideal circumstances. For many groups, the project takes shape as part of the writing process. While this scenario is not ideal, it is not uncommon. So don’t panic when things seem chaotic, even as you approach the submission deadline.  That said, please also recognize that while your writers are there to help you write up your ideas, they cannot design the project for you (though we certainly will offer opinions and advice.)


6. Do your policy homework, then apply anyway. Most large institutions have a team of policy wonks who can dig up some “intelligence” on the competition and the review process. While this process generally yields extremely valuable information for the writing team, be careful how you use it. The largest grant I ever landed was meant to be an earmark for another group. In fact, the anticipated recipient got at least as much press for their failure to land the grant as the awardee got for their success.


7. Respond to the funding opportunity announcement. Another obvious suggestion but you would be amazed how in the process of writing a lengthy application, the group can lose sight of the purpose of the FOA and veer instead toward their own interests. Sometimes a group has an idea for a center design that does not exactly fit the purpose of the FOA. Get out your shoehorn and make it fit. If you have an innovative model for medical care but the FOA is designed to expand access to or reduce the cost of care, figure out a way to spin the write-up so it fits the FOA. This is where a skilled writer can be invaluable.


8. You name it. If you are presenting a business plan for a multi-million dollar center, don’t you think that center ought to have a name? In addition to the fact that it will be easier to discuss in the application and in review, naming a center also lends credibility and validity to an entity. Names are often acronyms (or portions of it are acronyms.) Sometimes they are named after people (no, not the Program Officer, as one client recently quipped.) The advantage of naming after a person is that it can instantly create an image for the center if the person’s reputation or qualities are known within the field. It also can help with fundraising efforts down the line. Don’t be afraid to name after a living individual, if they are in the field they will understand if the project is not funded.


9. It takes a resubmission.  Please remember that the vast majority of NIH grants, including center grants, are awarded to applications on a second submission. So when the pink sheets come in and you want to commit hari-kari, try to remember this fact. Give yourself a few days to cry in your beer and contemplate a career change, then pull yourself and your team together and start planning your resubmission.


10. Tips for the application development team. I will conclude with a few words to the beleaguered application development team. I generally serve as lead writer on these teams so my advice is from that perspective: Implement a system for “version control”, as the document will be written by committee and you will need to incorporate input from dozens of people on numerous rounds of revisions for dozens of sections; Create clear timelines for intermediate milestones in the writing process, then recognize that you may not hit them and that you may need to adjust as you go along (within reason); Learn to delegate, both to members of your application development team and to members of the research team, and know when to bring in more writing help; Make clear to the research team when you are switching to “edit only” mode (i.e., no more sourcing and writing), and again when you have switched over to “formatting only” mode (no more edits thank you). Otherwise they will edit ‘til the cows come home, whether they have had a week or a year to write the damn thing. Applications can always be improved and editing is never actually “done”. Respect the timeline to submission and know when to cut the cord.


A final note…

Writing a center grant application is an arduous process and it will go much more smoothly if everyone in the trenches maintains a sense of humor. I don’t know where I would be without my team members making jokes at 4am when we are on our umpteenth straight night of minimal sleep. If you are on the writing team, try to keep everyone’s spirits up as you near submission. Remember that while this is your day (night, weekend) job, the researchers are working on the application in addition to their day job. Show patience and forbearance and heap on the encouragement as everyone staggers toward the finish line. And don’t wait for the funding decision—celebrate the submission itself! (Then go hang out with your family before they disown you. My delightful urchins have been known to come up to me after submission, shake my hand, and reintroduce themselves.)







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