The first slide is really to tell you about areas where we have been giving more emphasis and support for the RPGs between 2013 and 2019, and then just a high-level view of what some of the consequences have been.
First, we’ve increased the RPG pool for several fiscal years, starting with 2014.
Second, we established seven-year awards for outstanding investigators. That was in 2015.
And third, last year, we extended many early-stage investigator awards from five to seven years, using the R37 mechanism and preserved a higher pay line for early-stage investigators.
But there also has been an overall decrease in the number of R21 awards. And the reason that that is important is that it has to do with the turnover, or the average length of time, of an NCI award. Most of our awards are for five years, but the R21s—most of them—are for two years, and some are for three. The decrease means that we’ve taken that up by having more longer-term awards.
So, this increases the average duration of a typical award.
Ordinarily, the money that we get for the new and competing awards comes from money that has been turned over as a result of the last year of the awards, so the longer the duration is of the award period, the less money will be turning over each year. (Figure 3)
And so, what we have found is that we have needed each year to add a substantial amount of funding to the RPG pool, so that we can both maintain the level of new and competing awards, as well as trying to stay at 100% of the commitment for the out-year cost of the award, so-called Type 5 awards, the noncompeting out-year awards. (Figure 4)
RO1 applications have increased by almost 50%, and this has led to decreases in paylines and success rates. I’m going to go over some of this in the next few slides.
First, NCI, since 2013, has had an increase of just over 50% in the number of applications, and it’s about 10 times higher than that of the other institutes and centers at NIH. During that period, we have had a 20% increase in the budget.
I’m focused on the regular appropriation.
We, of course, have also benefited from the Moonshot, and a tremendous amount of research has been done through the Moonshot. But the Moonshot has a finite lifespan, and when it ends, in the last year of funding in 2023, it basically goes down to zero, and for long-term considerations, it really makes sense to focus primarily on the regular appropriation.
The RPG budget has more or less stayed steady with the increase in the budget, and I want to point out that we also have been doing a lot of other things with the budget outside the RPG pool. For example, the increases to the support grants for the cancer centers, and increase to funding for the cooperative groups.
This slide, actually—I talked with Tim Ley [NCAB member, a member of the NCAB Subcommittee on Planning and Budget, and professor of medicine and genetics at the Division of Oncology, Department of Medicine, Washington University School of Medicine in St. Louis] just a few days ago, and he asked, “What might be the story if you look at NCI, compared to other institutes?”
I don’t expect you to be able to read the slide, although it is available in the handouts (Figure 5). I just want to give you a few highlights.
First, let’s look at NIH in general.
Five years ago, versus the most recent, 2018. The success rate of five years ago was 16.8%, and in ‘18, it was 20.2%. So, an increase of just under 3.5% for NIH in general.
What has happened, on the other hand, for NCI, seen here in yellow, is we went from 13.7% down to 11.3%. This is for all of the awards; it’s not just R01s—it’s all of the awards in each institute.
Our R01 success rates, as you probably know or will see, are a little bit higher than that. I think, it’s really telling also when you look at the institute that was just above ours, here, it’s NIAMS.
They’re at 16.7%, whereas we’re at 11.3%—an enormous disparity, whereas five years ago, we were at 13.7%, and the next highest was less than a percent difference, the Fogarty International Center. (Figure 6)
I think you can appreciate that while the success rate of NIH in general has gone up with the increase in the budget, the success rate for NCI has gone down.
A little over 40% of the NCI budget goes into the RPG pool, and this shows you in this pie chart on the allocation for other parts of the NCI budget. The majority of the RPG pool actually for R01s, [which constitute] a little bit more than half, but there are many other mechanisms included in the RPG pool.
One question that people often ask is: “Are we getting into this problem, because our awards sizes are so much higher than that of the other institutes? And the answer is, “No, we’re not.”
In reality, our award sizes are lower, with the exception of 2015, than that of the other institutes, so this is looking at RO1.
The next two slides show you what the trends have been between 2013 and 2019 for the RPG awards by mechanism. This slide has the number of awards. The next slide will have the dollar amounts devoted to each of those categories of awards, and I would like to highlight three aspects. (Figures 7, 8)
First, I hope you can appreciate R01 dominates all the other individual components, and we went from a little under 600 awards to a little under 700 awards between 2013 and 2018.
The R31 awards have been bouncing around with a high of about 300 and a low of 100, in large part because we have a three-year trial of participating for the first time in the NIH omnibus R21. And it was felt that the increase in the number of applications and the quality of awards did not merit continuing to stay as part of the omnibus, and so going away from the omnibus led to a substantial increase in the number of awards with R21s. They’re shown here in the orange.
And then in the purple is shown the outstanding investigator awards, so-called R35, and it’s not that it’s such a large number of awards, but it’s a new award. We were starting from zero, and I just want to point out that—although the people who were in the R35s, all of them had R01 awards—we’ve continued to increase the number of R01 awards, while we also have had the outstanding investigator awards.
This slide shows you the trends in dollar amounts (Figure 8). The rate of rise for the R01s is faster than the rate of rise for the number of applications. That’s because we have increased the average dollar amount per R01. It’s just that we haven’t done it faster than that of other institutes, or at a higher rate than that of other institutes, and you can also appreciate here, in the orange, that the actual dollar amount for the R21s is relatively small, and the reason for that is, as I mentioned, the vast majority of the R21 awards are for two years, and here we’re looking at an aggregate, so the number of awards for R01s who are being multiplied then by five for some, then even by seven for others. So, this is a relatively small number. And here again in the purple are shown outstanding investigator awards.
This is taken directly from the online funding patterns that we published a few months ago for FY18, and some are earlier years. I’m showing it to you primarily for you to be aware that this information about the budget is available at the NCI website. But also, to show you that the unsolicited R01s in 2014 were at 15% success rate and it’s gone down to 12% success rate in 2018 and then the RFAs and the R01s went from 13% to 14%, so they have held a little bit more steady. (Figure 9)
There also is a great deal of information in the NCI Budget Fact Book, and you can consult that, again, available online, if you want more information and more detail.
This slide is to try to show you some of the actual dollar amounts and the actual number of awards. So, the R21s, as we’ve seen, have kind of bounced around, and these are the R21s, it’s the total unsolicited plus the RFA-associated R21s. (Figure 10)
And then, this is for the R01s, and as I mentioned, within FY2013, [when] we were under 600, and now we are a little bit under 700, as of FY18. These are the R35 awards, and we started out in the first year with the outstanding investigator awards a little bit over 40, and last year, it was 20.
We think that it makes sense to combine these two numbers, and that’s basically what you see here for total R01s and R35s, but basically again, under 600 here and under 700 here.
What’s happened to the competing RPG pool (that’s the new and competing renewals)? In FY13, the amount that was put in was about $400 million. That amount has been fairly steady for a number of years, but starting in FY14, we increased the amount to $450 million, and we then increased to about $500 million for each of the subsequent years.
The reason we wanted to try to provide as many awards as seemed fiscally responsible during this period, but as a result of increasing the amount of the awards, so here you’re basically increasing by $100 million, you need to add that additional $100 million, if you will, each time in the out-years.
And so, it’s actually turned out that we have been adding about $75 million per year to the total RPG pool, so between 2013 and 2018, it’s gone up a little bit less than $300 million. The plan for this year is to add about another $100 million to the total RPG pool, so it will be a total of about $400 million that has been added during this period.
So, what about the needs for the next couple of years? We’re still essentially recalibrating, and as we have more seven-year awards, that the amount of money that turns over in the year six and seven will actually go down, compared to what you would see if the awards had continued just for five years. (Figure 11)
This essentially envisions staying at $515 million for the new and competing awards, and this shows you what we estimate the total RPG pool will be at the end of this fiscal year, so $2.235 billion for the RPG pool, but we estimate that if we’re going to keep with the 100% commitment to the continuing grants, then we would need to add about $100 million next year for that, and that for FY21, we would need to add about another $55 million, and so the total would be about $165 million over this two-year period.
If we did for FY20 and FY21 what was done for this fiscal year, which was to commit at 97%, that is, take off 3%, and essentially put it into the new and competing awards, then we would only need to have a total of a little over $100 million, instead of the $165 million. (Figure 13, 14)
What if we essentially didn’t get an increase in the budget and we needed to basically do everything from within the RPG pool?
And so, if we only added $18 million over this two year period, we estimate that there would need to be an 8% reduction in the commitment for the continuing grants if this were going to be the scenario, and, clearly, this would not be a tenable situation.
I’m not providing this to say here’s what we’re planning on doing. Quite the opposite, just to show you what the consequences would be if we needed to take everything from the existing RPG pool at the end of fiscal year 2019.
This slide kind of summarizes where we are. The applications have gone up. Our estimate is that the applications have not gone up as rapidly in 2019 as they did in 2017 and 2018, but remember, we’re still in the middle of the fiscal year.
What happened in 2017 was that there were 500 applications more in 2017 than there were in 2016, and then in 2018, there were 600 more applications than there were in 2017, and we needed to essentially prepare for the possibility that there would be yet an additional increase of six of 700 applications. As I say, that hasn’t happened. (Figure 15)
We think that the increase in the applications is because there’s so much excitement about the opportunities in cancer research.
The number of applications per applicant has only gone up marginally during this period. It was 1.4 and it’s gone up to 1.55. Needless to say, the dotted lines are an estimate of projection.
If we look here at the budget, the House markup continues gives us another 5% increase to the budget, substantially higher than the president’s budget proposal, and we need to stay tuned to see what will happen.
We are committed to do what we can to both raise the payline in the next fiscal year, but it remains to be seen how hard or easy it will be to do that, and that will depend in no small part on what the budget situation is and the budget outlook is for 2020.
Thank you very much, look forward to your comments and questions.
Charles Sawyers [an NCAB member, chair of the NCAB Subcommittee on Planning and Budget, chair of the Human Oncology and Pathogenesis Program at Memorial Sloan Kettering Cancer Center, and professor of medicine at Weill Cornell Medical College]:
I wanted to make a framing comment, not a question directly to Doug.
So, it turns out I’m the chair of the planning and budget subcommittee for the NCAB. I and my colleagues on that subcommittee convened the meeting last night that Doug referred to. We had an extremely productive discussion, really grateful to Doug and his team for a thorough discussion of data, for options, etc. and on today’s agenda, I’m listed actually at the very end of the agenda to give a report back on that.
I want to keep it that way, but maybe we need a little more time, at least in the way we discuss that, but I want to just to tell everyone in the room: we take this extremely seriously. We had a productive conversation. As a subcommittee, we’re going to propose to the NCAB an action item, which would include, potentially, a letter to the NIH director, etc.
I want to hopefully during the lunch break etc. to have other people give me their feedback on this idea and we will probably circulate a draft of this prior to the end of the day’s report back.
Elizabeth M. Jaffee [NCAB chair, deputy director of the Sidney Kimmel Comprehensive Cancer Center, the Dana and Albert “Cubby” Broccoli Professor of Oncology, and co-director of the Skip Viragh Center for Pancreas Cancer at Johns Hopkins University]:
So, Doug, that was a great presentation.
So, we’re also hearing, besides what was discussed last night, we’re also hearing obviously about the risk of not seeing an adequate increase, and frankly $2 billion doesn’t mean adequate either, we’ve been getting $3 billion lately. And it’s not reporting the RPG pool.
This information is wonderful; how do we communicate that to Congress, so that they understand what the real issues are with real numbers?
To me, in terms of what I feel comfortable saying here, is that it is a reflection of the extraordinary opportunities that we have in cancer research, and we can point to mortality rates, for example, continuing to go down in cancer, in contrast to almost all other areas, in terms of leading causes of death.
The extraordinary advances in terms of specific diseases where mortality rates have been going down. And that this is really a result of first, basic research, then translational research, then clinical research—and that the pharmaceutical industry as [former NCI Director] Ned [Sharpless] pointed out, has more and more become oriented towards developing drugs for cancer treatment, and again, it’s a reflection of the research that has happened, but in addition, the opportunities of identifying more targets, trying to understand better, for example, drug combinations for cancer treatment, etc.
I think you want lead with the great opportunities, and as a result, I think that there are a lot of people trying to come into cancer research, and we simply can’t keep up with the demand, and what that means is that while historically we of course run out of money long before we run out of good ideas to test, now we run out of the money even faster, and there are even more good ideas to test.
Electra D. Paskett [NCAB member and the Marion N. Rowley Professor of Cancer Research, director of the Division of Cancer Prevention and Control at The Ohio State University]:
Thank you, Doug, I really appreciate that, and it really helps to have this complete vision of the funding.
I would agree with you, there are tremendous opportunities, and the NCI staff is just wonderful at working with us out in the field in terms of facilitating opportunities and working with us.
So, I would like to also add to the… I’ll call it the perfect storm, a couple of things that are happening in academia that I think have contributed to that increase that you’re seeing.
The first is that in cancer centers, we have an increasing mandate that NCI funding is the gold standard, and so cancer centers and those who are investigators at cancer centers have an increased pressure to get funding from NCI.
The second is, and it’s been happening for a few years—
Can I just respond and then you can go to the second [question] Karen Knudsen [BSA member, the Hilary Koprowski Endowed Professor, chair of the Department of Cancer Biology, and director of Sidney Kimmel Cancer Center at Thomas Jefferson University] in a previous meeting brought up the same issue, and we discussed this with Henry Ciolino [director of the NCI Office of Cancer Centers], and we’re going to try to clarify that the research does not need to be at NCI. Cancer-related, yes, but it doesn’t need to be at NCI. Second question.
Second point about academia is that many of us are seeing our institutions take away a lot of the hard money guarantee for salaries. So, in some institutions used to be 100% or 80%, that’s dropping back to 50, 30 and 20%, so there is more of an impetus for faculty to support themselves through grants, and that has really been changing over time.
And in addition, once you get or in order to get promotion, or you are an associate professor or higher, there is an expectation that you have two R01s, so there is really a lot more pressure in academia to have these grants.
And so, I think that’s what also is contributing to this, on top of the wonderful opportunities, and so, when you showed all of those institutes, have you also talked about perhaps when some grants come in that might be able to be co-funded with other institutes that you look at that, and I think that would be very attractive if you move forward to opening it to any NIH funding versus NCI.
Yes, this is, again, something that was discussed last night and has been discussed previously. The perception is maybe not quite as enthusiastic as you speculate, but certainly worth the discussion, which is appreciated.
One number that you may not be aware of is that the average number of awards that NCI grantees have from NCI is 1.3; okay? And that number has not changed dramatically. That in no way changes the pressure, but I just thought I would mention that. In other words, the majority of our grantees of NCI grantees have just one award.
Kevin M. Shannon [BSA member, the American Cancer Society Research Professor, Auerback Distinguished Professor of Molecular Oncology, and professor at the Department of Pediatrics, School of Medicine University of California, San Francisco]:
Doug, I have a very simple question, and then also a quick comment.
The question is: this is a really nice presentation by the way, a lot of great data here, 41% of the NCI budget going to the RPGs. How does that compare to the other institutes? Are we spending less relative part of our budget or are we spending about the same or more?
Kevin, we spend a bit less because we have many other mechanisms that they don’t have. For example, the cancer centers, so there’s nothing comparable to the cancer center support grants. If you want to argue that the CTSAs are analogous, the answer is but the CTSAs are actually supported by NCATS, not by the individual institutes. The cooperate groups are; I don’t think there’s anything comparable within the other ICs, just to give you two clear-cut examples.
So, one of those of those alliances are being in any discussion about decreasing for example, the number of RND contracts to try to build up the RPG pool over time.
We are continually looking to try to maximize the opportunities to fund the best research that we can in terms of contracts versus grants etc. Some of the contracts are highly meritorious, etc.
But we continue to scrutinize it. Let me emphasize that the kind of money that we’re talking about here is not enough to find $25 million, or even to find $50 million, because that’s a one-time deal.
Whatever program you don’t like, we could decrease it by that amount, but what happens the following year? What’s happening is that we have seen that we need to be at approximately $75 million a year of new money. In other words, it’s $75 million this year, and $150 million next year, and $225 million the following year, etc.
That’s why getting new resources is by far the preferable way of doing things. You’ve heard me say this before, all of our areas of research are underfunded. And so if we start taking away from other areas, we actually are going to be creating other problems.
I guess, just quickly, the comment I had is, I’ve had a T32, generously, from the NCI for a couple of cycles, and turned it over to another faculty member, but one of the messages we’ve been sending our young faculty, and of course it’s pediatric oncology, is don’t write your KOA to the NCI, write it to NINDS; if you’re studying neural tumors, write it to Heart, Lung and Blood if you’re studying NDS, or anything that’s not acute leukemia, try to sneak into DK if you’re studying hematopoiesis. And I worry a lot, I don’t know if my adult colleagues who have these T32s in the room have the same thing, but I worry a lot that once we get people out of the NCI early in their careers, they may get less focused on cancer, and start focusing on some of these other diseases, and these are the folks we’ve been nurturing and supporting to be cancer researchers. So, I just raise that as a possibility for you, considering this sort of budget conversation.
Let me just say that when it comes to early-stage investigators, we actually are supporting substantially more last year and this year than in the past. I don’t want to say that things are just fine, but it is probably easier for early stage investigator to get awards now than it was even three years ago.
Deborah Watkins Bruner [NCAB member and the Robert W. Woodruff Chair of Nursing at the Nell Hodgson Woodruff School of Nursing and associate director for outcomes research at the Emory University Winship Cancer Institute]:
Thanks again for the presentation, and we talked a little bit about this last night, and I just want to be sure it’s raised today, and maybe it will be later, but I think slide number five, to me, is the most telling slide.
Every other conversation is about different ways to dice the same pie, it is in slide number five that Tim had asked for that shows that the NIH is not taking an enterprise-wide view of resources.
They are taking each division you get what had last year plus 2.5%, maybe a little bit more if you’re lucky and you’re cancer, versus cancer is our top performing, has 10,000 applications, versus the applications of other units. We have decreasing mortality, incredible success.
If you’re a university and you had, say, a law school, which is losing applications and not doing so well, and a school of medicine doing great, and you still give a law school history plus 2% and the school medicine gets maybe the same and a little bit more, if they’re lucky—that’s a very old-fashioned way of looking at budgets, instead of looking at the enterprise.
In addition, those budgets still contain things where at the end of the year, you might have a little bit money, even in say, the law school who isn’t doing so well, so what you do is end of year budgets, everybody use it or lose it. Instead of taking that money and putting it into strategic initiatives in, the institute that really is doing wonderful, out-of-the-box, shooting-applications-into-the-sky areas.
There’s no enterprise way of redistributing resources, given the current funding model.
Again, we’re not the NIH advisory board, we’re the NCI advisory board, and what I’m saying would benefit the NCI, so I take that bias under consideration, but as a citizen, I would want my NIH to take an enterprise-wide view of resources.