Preliminary data and the new investigator

I’m just back from a nice meeting in an exceedingly exotic location and I’ve got to admit, I’m feeling nice and tan. I gave a presentation at the meeting and it went swimmingly, so swimmingly that many of the subsequent speakers were referring back to my talk throughout their following presentations. I know who I have to thank for that (if you’re reading, thanks again for the opportunity!). At this little meeting there was a nice dinner session on obtaining NIH grants. The session was hosted by two well funded extramural researchers (albeit in clinical areas) and one program officer. They all gave excellent talks although this particular dinner was not very well attended (my fellow junior investigators, WTF are you thinking skipping out on these things?). Onto the point… Throughout the talks, all three presenters raised the issue of preliminary data, both in terms of what this means for the new investigator and how it might change with the advent of the 12 page application.

First on the 12 page application issue. In a word: confusion. I think the consensus is that no one knows exactly how this is going to go over and no one knows what the right mix will be. The program officer indicated that there is going to be some effort to provide training to study section members on how to incorporate the new rules into a more uniform reviewing style. Dr. Program Officer wasn’t so sure how this would go over. Neither am I.

The discussion of prelim data for the new investigator was much more interesting and quite a bit more relevant to my present situation. The three presenters all agreed that the burden of preliminary data was less for the new investigator than for the experienced investigator. This assertion is in complete contrast to everything that I have been told by people that are on study section and have provided advice to me on preparing my NIH grants. How could this be? And who is right?

Let’s begin by stating that my expectations and the advice I was given may be about to change with the new grouping of early stage investigators into the same group for review purposes. Because of these changes there may be completely different approaches taken by study sections in the future when they review new investigator R01s. Despite this, it is still true that I have been told over and over again that new investigators have to be able to demonstrate quite clearly that they can do what they say they are going to do and they have to be able to provide overwhelming evidence that their studies are heading in the right direction before they can be considered for funding. Here there is some separation between feasibility (demonstrating that you can do the technique) and having a hypothesis that is strongly supported by preliminary data (for instance, that you have such overwhelming data in support of the idea that it becomes something of a sure bet) but my impression from what I have been told is still that the latter hurdle is especially high for new investigators. When I raised this issue at our little session I was told that this is not correct and that while new investigators need to be able to show feasibility, the data in support of the hypothesis is not expected to be as great as for a more experienced investigator. Basically, I have no idea how to reconcile these disparate views and I said as much in the session. No clear answers but the new rules for new investigators were referenced heavily in all responses. I then asked about the issue of uniformity in the review process across study sections. Let’s just say that this idea sparked an interesting discussion about cat herding.

So, what to do? I was very glad to hear that the recent NIH memos on R01s for new investigators was well supported by the voices at this little session. All us early stage people should heed this advice. I certainly will (continue to do so). Dr. Program Officer was quite clear in stating that NIH is very committed to making sure that new investigators have every chance to survive in this poor funding atmosphere. Those words did allow me to nap peacefully on the beach the next day.

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6 responses to “Preliminary data and the new investigator

  1. When I raised this issue at our little session I was told that this is not correct and that while new investigators need to be able to show feasibility, the data in support of the hypothesis is not expected to be as great as for a more experienced investigator.

    With the current system of new investigator R01s being reviewed and percentiled in the same pool as those of experienced investigators, this is a complete crock of shit.

  2. In reference to CPPs comment on percentiling of new investigator (NI) R01s and percentiling, check out what NHLBI is doing, as of Jan 09:

    “For applications funded starting in FY 2010 (received January 2009 and thereafter):

    * Re-percentile by: Amendment status (A0, A1), Investigator status (Early Stage Investigator, Established Investigator)

    * Pay by new percentile to equivalent success rates”

    Thus, this “rebalancing” will result in the table being shifted to favor A0s and New Investigators by doing separate percentiling. Effectively, the A0 and NI paylines will be increased, while A1/A2 and non-NI paylines will be decreased. A side effect noted is that administrative time should be lessened since study sections aren’t seeing grants over and over in what is effectively a holding queue.

  3. I think it *should* work so that the feasibility barrier is relatively high for new investigators, but not that the hypothesis is likely to be correct. But I highly doubt that’s what actually happens.

  4. Thanks for posting about this. It’s definitely going to be interesting to see which strategies are most successful.

    I like the idea of competing with people who are more like my “peers” rather than with established senior buddy-buddies.

    On the other hand, in a mock study section we did with a bunch of postdocs, it was frightening to be *evaluated* by a bunch of kids. Like Lord of the Flies.

    One of the things that has never made sense to me is the”peer” part of “peer review.” Seems to me this word is inserted more for appearances than for what it actually connotes.

  5. thanks for the advice. Is the 12 page application for ALL RO1s or just the T-RO1s? I can see both pros and cons for both.

  6. 12pages for all is coming soon, barring any sea changes from a new director.

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