NIH Funding to Study Sex as a Fundamental Variable in Clinical Research

Credit: Photokanok at FreeDigitalPhotos.net

I am popping up from my mountain of R01 drafts to bring attention to an important NIH news release. Yesterday, NIH announced it has devoted over $10 million in supplemental funding for 82 grantees to explore sex differences in their clinical and pre-clinical research.

The news release states, “These awards are the latest round of funding in a program described in a May 2014 Nature commentary by [Janine Austin Clayton, M.D., NIH associate director for women’s health research] and NIH Director Francis S. Collins, M.D., Ph.D. This commentary informed NIH grantees and other stakeholders of the agency’s intent to develop policies that will require applicants to address the influence of sex in the design and analysis of biomedical research with animals and cells.”

The news release states that the goal of the supplements is to serve as “…a catalyst for considering sex as a fundamental variable in research.”

NIH began this program in FY13, initially funding 50 supplements ($4.6 million total.) The initiative has been led by the Office of Research on Women’s Health. Most of the NIH ICs have funded supplements since the inception of the program.

Historically, medical research has been conducted predominantly on white male subjects. NIH has made efforts to expand the scope of clinical research to include both sexes and to represent multiple races and ethnicities. Grantees who want to succeed in the NIH arena would be wise to incorporate such variables into current and future studies.

 

 

Sequester Cuts to the NIH Budget Look Increasingly Likely

Guest Blog by Luke Bouvier, PhD

The day of reckoning is fast approaching as concerns the sweeping federal budget cuts known as “sequestration,” scheduled to go into effect on March 1.  Originally slated for January 1, 2013, the cuts were mandated by the Budget Control Act of 2011, which was enacted as part of that year’s fight over the increase in the federal debt ceiling.  In the hope that a long-term budget deal would make the automatic cuts unnecessary, their implementation was postponed by the New Year’s Day deal that averted the so-called “fiscal cliff,” but most observers now agree that there is little appetite for a political compromise that could avoid them once again.  On January 24, incoming chair of the Senate Budget Committee Senator Patty Murray (D-WA) released a memo outlining the history of the budget deals reached over the past two years as well as the current state of affairs.  The details are messy, but the consequences for the NIH are clear:  a cut of approximately 5.1% to the current year’s budget, or $1.57 billion, which would be all the more severe in that it would have to be squeezed into the remaining seven months of the fiscal year.

In an interview with Politico last month, NIH Director Francis Collins called the impending cuts “a profound and devastating blow” to medical research, adding that “there’s no sort of lever you can pull and all of a sudden everything will be fine” in the face of a cut of that magnitude.  Collins noted that over the past ten years, the NIH budget has been essentially flat, which means that inflation has whittled away about 20% of its value.  The looming cuts would greatly exacerbate that trend, at a time when cancer research is “just exploding with potential,” Collins said.  “We could go faster and faster; … it’s an incredibly exciting science, but it will go slower.”

Nature reported last week that scientists are already cutting back expenditures in anticipation of the cuts.  Senior officials at the science agencies are under White House orders not to discuss specific plans for implementing the cuts, but the Office of Management and Budget has directed them to minimize the impact of the cuts on their core missions and to give priority to concerns over life, safety, or health.  Nature reports that the cuts to the NIH budget would be spread over all of its 27 institutes and centers, with only its Clinical Center spared in order to avoid putting patients’ lives in danger.  Directors would have some discretion in apportioning the cuts, as long as the total adds up to 5.1%.  Given the uncertainty, the NIH has been paying only 90% of the promised amounts for previously awarded grants; if the sequester goes into effect, the final 10% of these grants would almost certainly suffer a significant cut, leaving principal investigators with difficult spending decisions to make.

As if sequestration weren’t enough, looming right behind it is another impending budget crisis, as the current fiscal year’s Continuing Resolution expires on March 27.  If no budget deal is reached by then, a government shut-down is a real possibility.  And following along close behind that deadline is the expiration of the debt ceiling suspension on May 19, which could lead to a US government default on its payment obligations in the absence of congressional action.

Are R03s and R21s Disappearing from NIH?

In a previous post I reported that NIDDK is the latest IC to pull out of the R21 program. My colleagues and I have been discussing (read: bemoaning) the demise of the small grant programs at NIH for some time, so it got me wondering about the actual numbers. Below is a table I created of data on the total number of awards and total funding under the R01, R03, and R21 programs over the past ten years. Below the table is a link to three line graphs I created from these data.

The R03 program appears to have peaked in 2004, with 1,632 awards and about $131.3M in funding. That number has been trending downward ever since, with 2010 numbers dipping to 1,058 awards and $87.3M in funding. Both of these R03 2010 numbers are about 65% of what they were at their peak in 2004.

The R21 program looks like it peaked in 2008 (3,649 applications and $678M in funding), with the numbers trending down since.

The number of R01 awards peaked in 2004 and have gone down each year since, dropping from 29,060 (2004) to 26,752 (2010). However the total R01 funding has remained relatively constant over the same time period and was actually at its highest in ten years in 2010 ($10.6B).

 

Click here for line graphs comparing R03 and R21

 

  R01- # awards R01- total funding R03- # awards R03- total funding R21- number awards R21- total funding
2001 26,173 $8,092,593,805 1250 $85,588,331 1279 $222,627,134
2002 27,568 $8,985,081,987 1378 $100,859,126 1822 $334,251,476
2003 28,698

$9,742,052,935 1506 $119,237,600 2464 $463,441,579
2004 29,060 $10,176,053,099 1632

$131,256,249

2934 $565,855,342
2005 28,622 $10,288,217,875 1603

$129,112,877

3056 $590,944,052
2006 28,192 $10,121,779,877 1409

$110,742,609

3126 $599,204,776
2007 27,850 $10,045,800,665 1430

$107,986,148

3453 $676,573,619

2008 27,012 $9,956,033,585 1479

$107,464,019

3649 $736,213,063

2009 26,580 $10,261,795,174 1284

$99,073,147

3271 $678,182,707

2010 26,752 $10,641,893,906 1058

$87,331,891

3124 $658,330,834

Source: NIH Reporter website. Total # awards excludes number of awards for noncompeting supplements 

Click here for line graphs comparing R03 and R21