Goal 3: Advance Translational Research

To facilitate innovation and accelerate research translation, knowledge dissemination, and implementation science that enhances public health.

Goal 3: Advance Translational Research

Accelerating Translational Research

NHLBI should define a strategy to promote collaborative research between clinician-scientists who perform patient-oriented research, and basic scientists who focus on the preclinical realm. There is not enough cross-talk between these two groups, and yet much to be gained from increasing interactions between the two (e.g. accelerating the translation of bench science findings into the clinic). In particular, funding strategies ...more »

Submitted by (@golan0)

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

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Goal 3: Advance Translational Research

Why are CHD Mortality Rates Much Higher in United States Than in Japan or Mediterranean Countries?

There remain very substantial unexplained international geographic variations in the incidence of CHD. Japan, for example, and some of the Mediterranean countries have CHD incidence rates for both men and women that are 1/3-1/4 of those in the United States.

Submitted by (@kullerl)

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

Details on the impact of addressing this CQ or CC :

Migrants from these countries have substantial increase in their CHD rates within a very short time after emigration to the United States or to other countries, strongly suggesting that fundamental genetic differences do not account for these variations in the rates. Reduction of the CHD rates in the United States to those in low risk countries will have the most profound effect on CHD and CVD incidence and mortality.

Feasibility and challenges of addressing this CQ or CC :

Research to further evaluate the probable dietary determinants of these extremely low rates and their implications to the United States should be a high priority. This includes careful study of fatty acids, especially polyunsaturated fatty acids, soy proteins, etc., interrelationships with markers of inflammation and inflammatory diseases. Japan, for example, not only has low CHD rates but also low rates of rheumatoid arthritis (RA), chronic obstructive pulmonary disease even in the presence of high levels of cigarette smoking, multiple sclerosis, all of which would suggest that inflammation may be contributing to these variations in risk of disease. Furthermore, there is growing evidence that omega-3 fatty acids and perhaps other fatty acids may play an important role in T cell function and the development of CVD.

Name of idea submitter and other team members who worked on this idea : Lewis H. Kuller, MD, DrPH

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Goal 3: Advance Translational Research

Lifestyle Interventions for Weight Control

What is the comparative effectiveness in comparison to usual care of scalable alternatives for delivery of evidence-based, comprehensive, lifestyle interventions for weight control that physicians can prescribe to patients either within the primary care setting or by referral within the community? What kinds of infrastructure changes are needed within the primary care setting to increase the effectiveness of these interventions? ...more »

Submitted by (@nhlbiforumadministrator1)

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

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

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Goal 3: Advance Translational Research

Congenital Heart Disease (CHD) Screening Access

What is needed to improve access to quality neonatal health care in order to get a more accurate idea of CHD prevalence in children, especially in underrepresented populations and those with limited access to primary care?

What role could safety net programs and community health centers play with screening (and subsequent treatment, education)?

Submitted by (@nhlbiforumadministrator)

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

Details on the impact of addressing this CQ or CC :

More accurate CHD prevalence numbers, especially in underrepresented populations and those with limited access to healthcare.

Feasibility and challenges of addressing this CQ or CC :

Agreement on CHD screening practices/standards.

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

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Goal 3: Advance Translational Research

Clinical Trial Methodology

As the current chair of the Research and Training Division, I would like to convey that the AAAAI membership would like the NHLBI to consider the following in the development of its strategic plan:

 

Are the current methodologies for clinical trials still the best practices for conducting efficient clinical trials?

Submitted by (@wheeze)

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

Name of idea submitter and other team members who worked on this idea : Mitchell Grayson on behalf of the American Academy of Allergy, Asthma, and Immunology

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Goal 3: Advance Translational Research

Create a National Action Plan for COPD

Lead a coordinated effort of government, patient advocacy organizations, professional organizations, payers and others to plan and implement a coordinated plan to improve COPD awareness, education for patients and healthcare professionals, treatment strategies, research and data collection, policies and public health infrastructure and programs.

Submitted by (@jsullivan)

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

Details on the impact of addressing this CQ or CC :

Unlike most leading causes of death and disability, there is no coordinated effort to lower disease burden associated with COPD. Coordinated plans provide a forum for identifying the most pressing issues that must be tackled, for setting goals and convening partners from different disciplines and are a framework upon which policy change can be achieved. In order to make meaningful progress in the impact that COPD is having on patients, health systems and payers, coordinated planning and action is needed and NHLBI can lead the way but time is of the essence.

Feasibility and challenges of addressing this CQ or CC :

There are proven models of multi-stakeholder, public and private partnerships to tackle disease burden and create national plans. There are also multiple national and regional organizations standing ready to assist in these efforts.

Name of idea submitter and other team members who worked on this idea : COPD Foundation Board of Directors, COPDF MASAC, COPDF State Advocacy Captains

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Goal 3: Advance Translational Research

Immune-Mediated hematologic disorders

What is the optimal approach to prevent and treat immune mediated hematologic disorders (autoimmune hemolytic anemia, immune thrombocytopenic purpura, etc) and complications of hematologic disease (inhibitors in hemophilia, transfusion-related alloimmunization, etc)

Submitted by (@barbarak)

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

Details on the impact of addressing this CQ or CC :

Therapies for these disorders are suboptimal and current treatments are associated with significant side effects. Transfusion is limited by development of alloantibodies..

Feasibility and challenges of addressing this CQ or CC :

NHLBI should support clinical trials in this area. Improved understanding of the biology and biomarkers predictive of disease development would aid in defining therapeutic approaches and trials.

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Goal 3: Advance Translational Research

Preventing Stroke from Atrial Fibrillation

How can health systems develop and implement validated measurement and feedback tools to identify patients with atrial fibrillation, categorize their risk factors for stroke, capture reasons for non-treatment, and develop interventions customized to those reasons to substantially improve the proportion of patients receiving effective oral anticoagulant stroke prevention treatment?

Submitted by (@grang001)

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

Details on the impact of addressing this CQ or CC :

Registries show that only about half of patients with atrial fibrillation and risk for stroke are taking oral anticoagulants. Given 4 million Americans with atrial fibrillation, half of whom (2 million) are not treated, with 5% stroke rate per year, 67% of which can be prevented, there are 67000 strokes occuring in this untreated population per year in the US. Assuming half of these could be treated if programs were develped that were proven effective, this would result in 33,000 strokes prevented per year.

Feasibility and challenges of addressing this CQ or CC :

NIH funds are needed to address the complex set of health system, psychosocial, and health IT issues to answer this question. Atrial fibrillation is a common condition with patients presenting and being treated accross various parts of the health care system. Small programs have shown promise for the use of the electronic health record to systematically identify patients with atrial fibrillation, but health system leadership needs evidence of success and guidance before this will be possible on a broad scale. With evidence of feasibility and impact, performance measures may be developed that would substantially enhance adaptation.

Name of idea submitter and other team members who worked on this idea : Chris Granger

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Goal 3: Advance Translational Research

Incentivizing Earlier Investment in NHLBI-Funded Technologies

How might NHLBI assist its awardees to attract private sector funding or partnerships earlier in the product development process to help bridge the gap between academic discoveries and product commercialization?

Submitted by (@nhlbiforumadministrator)

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

Details on the impact of addressing this CQ or CC :

Attracting private sector support earlier in the development pipeline would help fill an important funding gap between academic discoveries and product commercialization, enabling products to reach patients more quickly, and improving the return on NHLBI’s investments in basic research.

Feasibility and challenges of addressing this CQ or CC :

Some existing initiatives such as the SBIR Phase IIB Bridge and Small Market Awards encourage non-federal investors to invest earlier in NHLBI-funded technologies. In addition, the NCAI is designed to support critical feasibility studies and business case development to de-risk earlier investment by the private sector. These efforts are showing early signs of success, but impact only a small proportion of NHLBI-funded basic research discoveries.

Estimates for the cost of developing a new drug or device range from the hundreds of millions to billions of dollars and 10-15 years to get from the lab to the patient. The NHLBI cannot fully support that development, so private sector support is critical for biomedical technologies to be commercialized. Overall private capital investment in the life sciences is increasing, but it is not being targeted at heart, lung, blood, and sleep technologies or at the seed stage of development. Venture capital investment in heart, lung, blood, and sleep technologies has declined or remained stagnant since 2008 (http://graphics.wsj.com/venture-capital-and-the-human-body/) and seed stage investment from the private sector for early stage high-risk projects is in short supply (PWC Moneytree: https://www.pwcmoneytree.com/HistoricTrends/CustomQueryHistoricTrend).

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

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Goal 3: Advance Translational Research

Technologies for Ex-Vivo Cardiac Repair

What is needed to develop the technologies that will allow reparative interventions to be performed on excised natural hearts that have been overhauled ex vivo and replanted?

 

This will involve keeping the myocardium alive and sterile for extended periods that are long enough to complete the interventions while being able to also perform the necessary reparative interventions.

Submitted by (@nhlbiforumadministrator1)

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

Details on the impact of addressing this CQ or CC :

The long-term impact would be to alleviate the need for permanent circulatory support devices or transplants by providing a means for hearts to be repaired while patients are temporarily supported using total artificial hearts. The immediate impact of developing the technologies to do this would be that the necessary interventions for ex-vivo cardiac repair could be developed and tested leading to a new therapy.

Feasibility and challenges of addressing this CQ or CC :

A very basic foundation for this already exists. That foundation is an "Organ Care System" currently used in the UK to keep hearts functioning, not simply preserved, until the time of transplant for up to 12 hours. A timeframe of 5-10 years to extend the duration and the function of such a system for the stated purposes would seem feasible.

Repair and recovery of the heart is the currently limited to in vivo therapies. With the availability of artificial hearts and with the proper technologies available, the excised natural hearts from these patients could be overhauled ex vivo and re-implanted. Ideally, the overhaul would allow a way for various reparative interventions to be performed on the excised heart that would help to return it to a healthy functioning state before re-implantation. Such reparative interventions might include, but would not be limited to, surgical repair, adjunctive cell therapy, and stimulated exercise of the myocardium to influence reverse remodeling.

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

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Goal 3: Advance Translational Research

T4 Translation Research Informing Early Stage Translational Research

There is a need to utilize insights gained from T4 translation research and implementation science to inform the design and execution of early-stage translational research and clinical trials.

Submitted by (@nhlbiforumadministrator)

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

Details on the impact of addressing this CQ or CC :

• Assure that early stage translation research will be suitable for implementation in real world setting

• Aligns the research interventions from T1-T3 research to those appropriate to T4 research

• Potential to focus early stage research in key high burden areas

• Provides research community an understanding of the connections from early stage to late stage translation research which will potentially refine research strategies and directions at all levels

Feasibility and challenges of addressing this CQ or CC :

• Promote the importance of translation to population of heart, lung, blood, and sleep researcher to broader research community

• Potential for more T4 research contributions for guiding investment into translation research from T1-T3

• Provide avenues for T1-T3 investigators to translate their ideas into positive outcomes for population health

• Successful T4 research will stimulate feedback loop and identify opportunities for early translation research

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

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