Wednesday, February 18, 2009

FasterCures hosts a forum “Getting More Bang for Our Buck from the NIH Intramural Research Program”

by Margaret Anderson, COO, FasterCures

The Intramural Research Program (IRP) at the National Institutes of Health has a distinguished history of discovery, but it currently lacks a clearly defined mission for the 21st Century. In 2008 FasterCures convened a task force chaired by Nobel Laureate Dr. David Baltimore, which called for the IRP to adopt a new mission that is outcomes-focused, is capable of responding quickly to new opportunities and challenges, and that fully utilizes its world-class research hospital and other infrastructure. Given the likelihood of constrained budgets in the near future, it is especially critical that NIH make the best and most efficient use of the IRP, which consumes nearly ten percent of NIH’s budget.

Join FasterCures on Monday, February 23, 2009 from 9:00 am – 10:30 am to discuss the task force recommendations on how to strengthen the mission and impact of the IRP.
For more information and to RSVP.

Tuesday, February 17, 2009

National eHealth Collaborative Launched

by Kate Blenner, Program Analyst, FasterCures

The national entity charged with prioritizing standards for health IT launched in January, and FasterCures is serving on a parallel effort to ensure that clinical research applications of health IT will remain a top priority to it and other health IT regulators.

On January 8, the successor to the American Health Information Community (AHIC) was relaunched as the National eHealth Collaborative (NeHC). AHIC originated as a 2005 federal advisory board to the Office of the National Coordinator; in its new iteration as the not-for-profit NeHC, it will operate as a public-private partnership to set priorities for IT standardization through its diverse stakeholder membership.

A key initiative of the new NeHC will be setting national priorities for HIT via analysis of ‘value cases’, distinct from ‘use cases’ in that they present cost-benefit analysis of adoption in the context of monetary, business, societal, and technological risk. NeHC is expected to open a call for value case submissions this month.

The concept of a value case should be familiar if you have been following the world of patient safety and care quality improvement, where “making the business case” for any improvements in healthcare delivery systems is nearly the norm. An ample body of literature and reports exists as templates for health IT value cases of established care processes and delivery channels. But how does one anticipate the value and risks of an integrated system that connects healthcare, clinical research, and translational research information-a system that is currently just a gleam in the eye of biomedical research advocates?

FasterCures is part of a working group hoping to do just that. The American National Standards Institute has formed the EHR Clinical Research Value Case Workgroup to develop value cases for interoperability between electronic health records and clinical research applications. We look forward to working with the Workgroup, NeHC, and other leading entities to ensure that an interoperable health IT system interfaces with the clinical and translational research world and is one less barrier to expedient delivery of new discoveries to patients.

Wednesday, February 11, 2009

Could Innovation be the Key to Overcoming the Economic Crisis?

by Angelo R. Bouselli, Communications Manager, FasterCures
According to a recent Wall Street Journal, article hard economic times could drive innovation. In the article, Harvard Business School professor Clayton M. Christensen discusses how breakthroughs in innovation come when economic resources are limited. Christensen goes on to say, “If you give people a lot of money it gives them the privilege of pursuing the wrong strategy for a really long time.” Christensen discusses how prosperity tends to insulate the market from innovations, and he thinks that by forcing innovators not to waste so much time, the economic downturn will have a positive effect on innovation.

To put innovation and medical research into perspective, the NIH will spend $29.5 billion on basic and applied medical research. Over 80 percent of the money goes to fund 50,000 grants to 325,000 scientists in the U.S. and overseas. The next NIH director faces serious challenges.

A new report, “Rebuilding our Economy: Investing in Research Critical to our Nation’s Health,” released by Research!America, focuses on the issue of investing in medical research to solve some of the underlying problems in our nation’s economy. According to the report, “half of the growth in the U.S. economy is commonly attributed to the knowledge and innovation driven by research. Long recognized as the foundation for innovation, research has been shortchanged.” Research!America estimates that $122 billion was spent in 2007 on research to improve health. That amount might seem like a lot. However, it’s only 5.5 percent of the $2.25 trillion spent on healthcare in the U.S. in 2007.

In order for the U.S. to maintain its position as a global leader in science we will need to re-establish research as a priority. According to Christensen, one of the benefits of the economic crisis is that it increases the pressure to find solutions to healthcare problems. The U.S. has a unique opportunity to completely rethink some of the basic assumptions that have made innovation in healthcare seem impossible. Investing in innovation and research is more critical to our nation’s overall health than ever before.

The economic crisis can force companies to be more innovative and resourceful. At FasterCures, we believe that the federal government needs to spend more on medical research and that it’s good for our economic health to invest in science that will create the jobs of tomorrow. But, we also believe that the economic crisis should cause us to take a careful look at how we are investing the resources we’ve already committed. Are resources being spent in ways that ensure science will lead rapidly to new products that are good for patients and good for the economy?

Thursday, February 5, 2009

Improving Clinical Trials: "Yes We Can"

by Kristin Schneeman, Program Director, FasterCures

Probably one of the most persistent problems slowing medical research that we hear about at FasterCures is that the cost in time and dollars of clinical trials is crushing the discovery enterprise. Professionals from all corners of the clinical research enterprise express frustration with the complex web of problems and the long-term gridlock they perceive. They are weary of devoting time and energy to any effort – whether a one-time conference, an ongoing process, a consortium or alliance – that will revisit the “same old issues” surrounding clinical trials.

In the spirit of the New Year, we’d like to highlight some heartening efforts from a variety of quarters to stop griping and try to solve some of these thorny problems. They’re all very different, yet what links them is their optimism that change is possible.

The National Cancer Institute and the CEO Roundtable on Cancer are engaged in an ongoing effort to develop "model language" for use in the contract agreements that govern clinical trials. The model language covers seven areas in which negotiations regularly stall, including intellectual property, study data, indemnification, subject injury, confidentiality, publication rights, and biological samples.

Duke University is hosting an effort springing from FDA’s Critical Path effort, the Clinical Trials Transformation Initiative (CTTI). CTTI is a public-private partnership that will include broad representation from government, industry, patient advocacy groups, professional societies, and academia. Its more than 50 members will work together to develop new standards and identify new methods and technologies that improve safety, boost the quality of information derived from clinical trials, and make the research process more efficient. This is not another exercise in analysis paralysis; it is meant to be a practical effort to generate data and test solutions.

And finally, the Dr. Susan Love Research Foundation and the Avon Foundation have recently joined forces to launch the Army of Women Web site. This is a new and different way to engage people in clinical research – not a walk or a telethon, but an opportunity to directly contribute to research. Army of Women seeks to recruit one million healthy women of every age and ethnicity, including breast cancer survivors and women at high-risk for the disease, to partner with breast cancer researchers and directly participate in research; and to challenge the scientific community to expand its current focus to include breast cancer prevention research conducted on healthy women. Women can register to be notified of opportunities to participate in research projects (by mailing in blood, saliva, even breast milk samples, filling out questionnaires, etc.).

Within each patient is a Rosetta Stone of information that could unlock the potential to cure disease. It’s nice to know not everyone has stopped trying to solve the puzzle.

Monday, February 2, 2009

Public Service Announcement Inspired by Danny Federici

The Melanoma Research Alliance has partnered with Bruce Springsteen, the E Street Band, and the Federici family to alleviate suffering and death from melanoma. Please view Bruce Springsteen’s public service announcement inspired by Danny Federici. Danny was the E Street Band’s organist and keyboard player. He died on April 17, 2008 at Memorial Sloan-Kettering Cancer Center in New York City after a three year battle with melanoma.