As we all know, comparative effectiveness research is smokin’ hot right now. We are all anxious to see what PCORI funding produces in the upcoming years. In December they unveiled PCOR-net, a highly innovative, clinical data sharing network. In a recent blog post, Dr. Francis Collins (who sits on PCORI Board of Governors) stated, “This initiative will provide an unprecedented opportunity to streamline clinical trials, empower patients, and build a solid foundation for personalized medicine.” He goes on:
“PCORnet will be made up of two types of data networks: Clinical Data Research Networks (CDRNs) and Patient-Powered Research Networks (PPRNs). CDRNs include academic health centers, community hospitals, health plans, inpatient and outpatient hospitals and providers, Veterans’ Administration clinics, pediatric hospitals and providers, private electronic health record companies, and many other health care groups. Utilizing electronic medical records, all of these organizations will build patient databases and a clinical trial infrastructure that can be accessed by researchers from many different organizations (including NIH), while protecting patient privacy and confidentiality.
“As the name suggests, PPRNs are patient-oriented groups united by a certain disease or condition. The successful groups receive support from PCORnet, and are charged with outreach, expanding networks of patients, and collecting standard patient data—all of which are critical for researchers looking to recruit volunteers for a clinical trial.”
In December, PCORI distributed $93.5 million to 11 CDRNs and 18 PPRNs who will conduct pilot studies on data models over the next 18 months.
If successful, this single, overarching network has the potential to include over 100 million people across the US of all ages, ethnicities, and SES who have agreed to participate in clinical research.
Read the complete blog post here.
Guest Blog by Luke Bouvier, PhD
In a notice issued a few days ago on February 21, the NIH released some additional details about its contingency plans if sequestration goes into effect this Friday, March 1, as scheduled. In order to hit the mandated 5.1% budget cut, the NIH “likely will reduce the final FY 2013 funding levels of non-competing continuation grants and expects to make fewer competing awards.” Non-competing continuation awards, which have generally been funded this year at 90% of the previous commitment level because of the ongoing budget uncertainty, may see some restoration above the current level “but likely will not reach the full FY 2013 commitment level described in the Notice of Award.” The NIH also confirmed that in the event of the budget sequester, each of the 27 NIH Institutes and Centers will detail its own approach to meeting the reduced budget level.
Science likewise reported that a press conference held at the NIH last week confirmed the bleak budget outlook. NIH Director Francis Collins and Senator Barbara Mikulski (D-MD) warned that the coming sequester cut of $1.57 billion to the NIH’s $31 billion budget would “slow scientific progress, delay clinical trials, and put a generation of young researchers at risk.” Collins reported that “everything will take a hit,” though Institute directors will be able to use their discretion in allocating cuts among programs such as single-investigator grants, centers, and intramural research. Referring to NIH staff and intramural researchers, Collins added that “we will do everything we can to try not to furlough or to lay off employees.” Nobel Prize winner Carol Greider, chair of the Department of Molecular Biology and Genetics at Johns Hopkins University, also appeared at the press conference and lamented that the looming cuts could reduce NIH’s grant success rate from an already-low 17-18% down to 15%, which would translate to a reduction of grants in the hundreds, forcing cutbacks in biomedical labs throughout the country. Collins confirmed that many high-scoring grant proposals have not received any funding yet at all because of the lack of budgetary clarity, adding that “some of that science is being held up as we try to figure out what resources we actually have in fiscal year ’13.” Though few observers now believe that the sequester cuts can still be averted by March 1, Senator Mikulski, chair of the Senate Appropriations Committee, hopes that the NIH cuts will eventually be remedied in a budgetary deal to fund the federal government through the remainder of the current fiscal year. That deal would have to be reached before the current Continuing Resolution expires on March 27, or else a government shutdown could result.
Guest Blog by Luke Bouvier, PhD
On January 7, 2013, the U.S. Supreme Court declined to review Sherley vs. Sebelius, which effectively ends the legal challenge to the 2009 NIH Stem Cell Funding Guidelines. The Guidelines, which allow funding of most stem cell research, were challenged by two researchers who work with adult stem cells, James Sherley and Theresa Deisher, as a violation of U.S. law, which prohibits the NIH from funding research in which human embryos are destroyed. In 2010, a federal judge blocked the 2009 Guidelines, but the U.S. Court of Appeals for the District of Columbia Circuit reversed that decision in August of 2012, deferring to the NIH’s judgment that it could fund research on stem cells from embryos that are not actually destroyed during the research. The Supreme Court’s refusal to take up the case effectively upholds the Appeals Court decision and lifts the cloud of uncertainty over future stem cell research funding.
NIH Director Francis Collins welcomed the decision, stating that “patients and their families who look forward to new therapies to replace cells lost by disease or injury, or who may benefit from new drugs identified by screening using stem cells, should be reassured that NIH will continue supporting this promising research.” Likewise, Amy Comstock Rick, president of the Coalition for the Advancement of Medical Research, greeted the Court’s decision as “a victory for scientists, patients, and the entire biomedical research community,” noting that the NIH currently lists 198 stem cell lines on its registry, up from 21 in early 2009 when the NIH first implemented President Obama’s executive order lifting President Bush’s ban on funding for all but the most limited stem cell research. Bernard Siegel, spokesperson for the Stem Cell Action Coalition and Executive Director of the Genetics Policy Institute (GPI), applauded the decision as “a major victory for scientifically and ethically responsible innovative research” adding that while the legal challenge to the NIH’s 2009 guidelines is now over, “we must remain vigilant against threats at state and other policy-making levels.”