Showing 4 ideas for tag "new"

Goal 4: Develop Workforce and Resources

Suipport new research using the R21 mechanism

The decision by NHLBI to not support the R21 mechanism may be stifling new and innovative research, partcularly by young investigators who do not have a track record of R01 funding. The critical challenge is to keep funding new ideas from younger investigators to keep their careers viable while they obtain the data and publications necessary for further R01-level funding.

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Critical Challenge (CC)

Details on the impact of addressing this CQ or CC

The state of NHLBI funding rates for R01s are so low that we are undoubtedly loosing many young researchers as the fail to obtain adequate support for their research. Funding R21 grants will allow new, innovative, and perhps risky projects to proceed, while keeping less established researchers in the field. Re-establishing R21 funding may prevent the impression that NHLBI is more interested in supporting established labs and not advocating for and supporting new investigators.

Feasibility and challenges of addressing this CQ or CC

Given the limited budget of R21s, they will not have as large an impact on the overall budget of NHLBI as the equivalent number of funded R01 grants. Therefore, this change is feasible from a financial standpoint. Obviously, funding R21s will decrease funding for other mechanisms. Finally, it is possible that many of these grants will not lead to advances in the field, but it is my understanding that studies show the same thing about R01s.

Name of idea submitter and other team members who worked on this idea George Porter

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Goal 3: Advance Translational Research

Promoting Research on Translation of Evidence into Practice within Academic Medical Health Care Systems

Academic Medical Centers (AMCs) must become translational research leaders by conducting implementation research (IR) within their own health care systems. Doing so will require new paradigms, breaking down silos between research and operations, new incentives, and new funding streams. Steps include CTSA renewal requirements for significant IR and building on the QUERI (Quality Enhancement Research Initiatives) from... more »

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Critical Challenge (CC)

Details on the impact of addressing this CQ or CC

AMCs are the engines of scientific research in the US. They possess the brain power, resources and reputation necessary to alter the trajectory of the translational continuum of research. Currently 62 AMCs are funded through CTSA in 31 states. Through their own health systems and their affiliates, AMCs provide health care to a sizable portion of the US population. Most AMCs now use the same EHR (EPIC). Nearly all are embarking on system change including establishing accountable care organizations, bundled payments, and medical centered homes. These assets provide fertile ground for research on how to best implement scientific evidence into health care to achieve the triple aim: improved care to patients, improved health to populations, and reduced costs. If AMCs take IR to heart, this could be a game changer. Success could establish a virtuous cycle whereby improved health and reduced costs convinces a skeptical Congress to authorize greater funding for NIH tagged to IR. This change requires moving AMC rhetoric into action and becoming leaders in IR in their own back yards.

Feasibility and challenges of addressing this CQ or CC

The major challenges are new paradigms, incentives, infrastructure, and funding. Most AMCs regard health care systems operations and research as separate. Despite the mantra to become "learning health care systems" few AMCs conduct IR within their own health systems. Changing this paradigm will require incentive to change, new infrastructure including new types of teams, and funding streams. The CTSA renewal mechanism represents a starting place but this will need to be coupled with program announcements and center awards that establish a QUERI like infrastructure including teams of IR researchers, health care administrators and PBRNs. The challenge is great but a new paradigm is critical if scientific research is to guide the seismic changes that are occurring in within US health care.

Name of idea submitter and other team members who worked on this idea Kevin Fiscella, MD, MPH

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Goal 3: Advance Translational Research

Safety and effectiveness of new direct oral anticoagulants

What is the optimal use of new direct oral anticoagulants?

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

Details on the impact of addressing this CQ or CC

Vitamin K antagonist, warfarin, has traditionally been the mainstay of anticoagulation therapy. It requires frequent monitoring to maintain safe and effective dose and is associated with many food and drug interactions. A new generation of direct oral anticoagulants has been developed to overcome such shortcomings.
Two main classes of new direct oral anticoagulants are available: factor Xa inhibitors and factor IIa (thrombin) inhibitors. Their mechanism of action involves direct inhibition of a single factor within the coagulation cascade to exert an anticoagulant effect. The industry is positioning them as monitoring-free universal warfarin replacement products. However, use of new direct oral anticoagulants introduces two major clinical issues: majority of new generation anticoagulants do not have developed dose-monitoring assay and do not have antidotes to rapidly restore blood coagulation properties in patients with trauma, emergent surgery, or anticoagulation overdose. Addressing these issues would positively impact cardiovascular, pulmonary, benign hematology, and orthopedic services worldwide.
While the idea of a universal, low-maintenance, “one dose fits all” anticoagulant is highly appealing to both patients and physicians, it may be feasible to consider more targeted approach, where each new anticoagulant would be assessed for most plausible effect in the specific patient population with consideration to genetic s, sex, race, age, thrombosis history, and obesity

Feasibility and challenges of addressing this CQ or CC

Rapid advancement in the field of new generation direct oral anticoagulants and multiplicity of new drugs introduce opportunity to conduct comparative effectiveness research and assess how different characteristics of new products may be appropriate for different patients. Increased use of new direct oral anticoagulants requires expedited development of assays and antidotes for safe and efficient therapy of millions of Americans.

 

A challenge is that the majority of the clinical trials for new direct oral anticoagulants were conducted by the industry with the main goal of demonstrating superiority, or non-inferiority to warfarin. Secondary analyses of these trials’ data for efficacy in specific patient population may be difficult. Prospective clinical studies in this area may require large sample size and establishing collaboration between hematologists and other involved clinicians.

Name of idea submitter and other team members who worked on this idea NHLBI Staff

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Goal 3: Advance Translational Research

Increased testing of new ideas

As indicated in two influential papers we have published, there are many potential contributing factors to obesity beyond those commonly discussed and studied and some of these are potentially modifiable. Increased research to understand whether these putative factors are really influential and whether they can be modified to produce benefits with respect to obesity are in order.

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Critical Challenge (CC)

Feasibility and challenges of addressing this CQ or CC

The two papers we referenced in this Critical Challenge were: 1) Keith SW, Redden DT, Katzmarzyk PT, Boggiano MM, Hanlon EC, Benca RM, Ruden D, Pietrobelli A, Barger JL, Fontaine KR, Wang C, Aronne LJ, Wright SM, Baskin M, Dhurandhar NV, Lijoi MC, Grilo CM, DeLuca M, Westfall AO, Allison DB. Putative contributors to the secular increase in obesity: exploring the roads less traveled. Int J Obes (Lond). 2006;30(11):1585-94. doi: 10.1038/sj.ijo.0803326. PMID: 16801930; and 2) McAllister EJ, Dhurandhar NV, Keith SW, Aronne LJ, Barger J, Baskin M, Benca RM, Biggio J, Boggiano MM, Eisenmann JC, Elobeid M, Fontaine KR, Gluckman P, Hanlon EC, Katzmarzyk P, Pietrobelli A, Redden DT, Ruden DM, Wang C, Waterland RA, Wright SM, Allison DB. Ten putative contributors to the obesity epidemic. Crit Rev Food Sci Nutr. 2009;49(10):868-913. doi: 10.1080/10408390903372599. PMID: 19960394; PMCID: PMC2932668.

Name of idea submitter and other team members who worked on this idea David B. Allison, Ph.D.; Kevin Fontaine, Ph.D.; Kathryn A. Kaiser, Ph.D.; Andrew W. Brown, Ph.D.; Edward C. Archer, Ph.D.

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