Archive for the ‘NCI’ Tag

NIH Issues Draft Policy That Would Require A Single IRB For Multi-Site Clinical Trials

For years, grantees have been encouraged to use a shared IRB in multi-site clinical trials as part of shared research networks at NCI, and it appears to increase efficiency without compromising protection. In early December 2014, NIH released a draft policy proposing that multi-site trials in the U.S. be required to use a single IRB. NCI has already conducted an analysis demonstrating that a single IRB decreases time and costs when compared to having individual IRB at each participating clinical site. To read and comment on the draft policy, click here. NIH is eliciting input until January 29, 2015. A commonly used model of joint IRB review is IRBshare, which according to its website “facilitates the sharing of full board approved documents between IRBs, accelerates the initial review process by enabling a temporary reliance between IRBs, and minimizes the need for all sites to conduct a full board review.” See the IRBshare website for details.

NIH FY11 Budget On The Chopping Block?

As the White House and House Republicans continue to negotiate toward a Thursday deadline for an FY11 budget to fund the final six months of the year, it appears that NIH may be on the chopping block. Rumors are all over the place and no definitive information seems to be available. An earlier Senate budget plan would have maintained NIH funding at its FY10 level. But with $38 billion to cut from the budget, any nondefense discretionary spending is at risk.

While I hesitate to link to an article from a partisan journal like The Nation without balancing it with other viewpoints, alas there is little definitive news arising from the murky depths of “budget negotiation hell” this week. So with that caveat, I encourage you to take a look at this article in The Nation.

The author states that NIH’s $31B annual budget accounts for one-third of the Department of Health and Human Services discretionary spending. She argues that cutting the budget would not make a meaningful dent in the budget deficit, as NIH only accounts for 2.9% of total discretionary spending.

Research funded through NIH extramural funds would not be supported by other sources. For-profit companies will develop promising research through R&D, but basic science funding must first get a project to the point where it shows enough promise to be developed.

The author goes on to say that if there were cuts, “The NCI will prioritize funding the same level of new grants (they currently fund 14 percent of new grant applications), but will have to cut funding from cancer centers. Others will have to choose between new and existing grants. When ongoing grants aren’t renewed, work may simply stop.” The fear is that we will lose the best and brightest scientists to industry, other fields, and/or other countries with a less draconian funding climate.

She states further, “Funding ‘basic science’ doesn’t sound appealing in lean-budget times, but cutting research in times of economic woe is counterproductive. Nearly 90 percent of the NIH research budget gets distributed across the country, employing scientists and lab technicians.”

Need I add that we as a nation spend billions of dollars each year treating preventable diseases? I recently blogged about the upcoming Community Transformation Grants, which target such diseases. It is funded through the Affordable Care Act, all aspects of which are at-risk for funding cuts– which seems economically short-sighted to me.

The author of the article concludes with the compelling statistic that each year 300,000 people die of cancer, which is the equivalent of losing 3,000 people in the Twin Towers every other day. She encourages those who support traditional defense spending to consider which enemy poses the greatest threat, and asserts that biomedical research is our best defense.

Many groups are organizing campaigns to oppose possible NIH budget cuts. For example, the Pancreatic Cancer Action Network has organized a Facebook page to “Help Oppose NIH Budget Cuts” And many biomedical research groups and foundations are encouraging members to contact their senators and representatives.

I know I posted this quote in support of basic science research recently, but given the circumstances this week I feel it bears repeating:

“None of the most important weapons transforming warfare in the 20th century- the airplane, tank, radar, jet engine, helicopter, electronic computer, not even the atomic bomb- owed its initial development to a Doctrinal Requirement or request of the military.”

John Chambers, ed. The Oxford Companion to American Military History (New York, Oxford University Press, 1999 p. 79.)

New strategic plan for NIH obesity research seeks to curb epidemic

Today the NIH announced the release of its new strategic plan to combat obesity. The Task Force that developed the recommendations was composed of researchers, health care professionals, and the public and was chaired by the Directors of NHLBI, NIDDK, NICHD, and NCI.

Task Force recommendations include prioritizing research to:

· discover key processes that regulate body weight and influence behavior

· understand the factors that contribute to obesity and its consequences

· design and test new approaches for achieving and maintaining a healthy weight

· evaluate promising strategies to prevent and treat obesity in real-world settings and diverse populations

· use technology to advance obesity research and improve healthcare delivery

NIH’s first strategic plan for obesity was released in 2004 under Elias Zerhouni. In FY2010, NIH spent $824M on research to reduce the prevalence of obesity and its health consequences. Look for that funding level to continue even with budget cuts looming on the horizon, as NIH continues to commit itself to what is arguably the number one public health crisis in the country. One-third of adults in the US and 17% of children are obese. The most prevalent, deadly, and costly diseases in the US—heart disease, type II diabetes, and many cancers—are directly related to obesity.

This topic is near and dear to my heart (I trained as a ballet dancer, have been a runner for years, and am writing this blog upon returning from a Pilates class.) By choice, many of my grant and policy clients are exercise physiologists and I have a satisfying, ongoing business association with the American College of Sports Medicine, an organization for which I have a great deal of respect. I am delighted to see NIH reaffirm its commitment to this troubling area.

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