Why Preliminary Data is Essential for Successful NIH R01 Grant Applications
You’re already aware that you need preliminary data for a successful R01 application, but what gets a bit lost for early career research is the nuance around why you need that data.
Whether you understand it yet or not (and don’t worry, I’m going to make it all make sense), your preliminary data plays an important role in writing a successful NIH R01 application.
The Research Before The Research
You’ve probably heard the common complaint that doing preliminary research is like doing an R01 before you get funding to do an R01. This complaint speaks to the idea of needing so many resources to even get your foot in the door at NIH.
This critique is certainly valid, but there’s more to it.
And a good place to start is understanding how to think about preliminary data in your application and why you need it.
The prevailing view of preliminary data in an R01 is to demonstrate feasibility. A lot of people just include it in their approach section to demonstrate that they have experience with the techniques or approaches that are required to be successful.
What this is basically doing is telling your reviewers that you’ve done this before, so you know what you’re doing.
Even if that may be true, another vital use of preliminary data in your R01—a use that I think is often misunderstood—is in setting up your argument for your overarching hypothesis/research question and the design of your aims.
Your Significance Section
When it comes to laying out the argument for why your research needs to be done and why it’s important, preliminary data plays a vital role. And understanding the structure of your significance section creates the argument for the preliminary data and the overall design of your aims.
One of the first things you need to do in your significance section is lay out the argument for why the research needs to be done in the first place.
This involves laying out a big, juicy scientific problem you’re trying to solve over the long term. Then, you lay out the gap in knowledge that you’re going to focus on in your grant.
To do that you need to describe what’s known about the wider problem and what’s not yet known (the gap). But in laying out the gap you will have identified an overarching hypothesis about what’s going on (or, if you’re not doing hypothesis-driven research you’ll have a central question that’s motivating the research). That overarching hypothesis/central question is usually derived from preliminary research that’s pointing you in a particular direction.
Once you’ve described the gap in knowledge your research will fill, then you can move to discuss how you’re going to go about filling it.
And those are your aims.
Explaining Your Aims
You also need to paint the picture as to how you got to your aims, including how and why you designed them the way you did.
In the significance section, what my team and I recommend to early career researchers is that you talk about this at a really high level. At this high level, you’re explaining what’s already been accomplished, sharing the early promising evidence of X, Y, and Z, and explaining how that previous work is forming the basis of your aims.
This looks like describing the key evidence that led you to develop your aim and what you’re trying to accomplish in the aim. If you’re doing hypothesis-driven research, usually each aim is informed by preliminary data and will have its own sub-hypothesis.
Because this is a high-level view, you aren’t going to get into the nitty gritty and the details. That more detailed level is reserved for your approach.
Essentially, your preliminary data becomes a key way to justify the scientific premise of what you’re doing, so it’s absolutely crucial to build that into the overall argument for why your research needs to happen.
It’s bigger than just feasibility and so much more than just saying take a look and see that we’ve done this before.
This is an opportunity to walk reviewers through your thought process for the development of your research idea. And to do that effectively and make a really strong R01, your preliminary data will do the heavy lifting.
Get Your Reviewers On Board
If you have all your pieces in place in your significance section, then it becomes really easy to explain the innovation of your project and get your reviewers in your corner.
They will already be on board with your thinking because they understand how you got there—how you arrived at your overarching hypothesis and how you developed your aims at a conceptual level. Once that connection is in place, you can move forward and explain in detail how you’re going to do it. When you paint a clear picture with your preliminary data—from both a scientific premise and feasibility perspective—you’ll have a much stronger R01 that gets you one step closer to getting funded.
Free Resource Library
If you found this helpful, I strongly encourage you to sign up for our free resource library. We have lots of tools and tutorials in there to help you write a stronger NIH grant that gets reviewers excited about the potential of your research idea. There are also lots of other tools in there to help you plan and prepare your next grant so that you are organized and ready to go.