(@nhlbiforumadministrator)

Goal 2: Reduce Human Disease

Phase III efficacy trials of tuberculosis drugs

1) Phase III efficacy trials of new tuberculosis drugs (e.g., bedaquiline, delamanid, PA-824) that have shown promise in early phase studies for multidrug-resistant tuberculosis. 2) Phase III efficacy trials of new and existing tuberculosis drugs to development very short course regimens (3-4 months). 3) Phase III efficacy trials of new and existing drugs for treatment of latent tuberculosis infection in contacts of... more »

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(@nhlbiforumadministrator)

Goal 3: Advance Translational Research

Increased receptivity to probative programmatic trials

We believe there should be greater openness to large, simple trials that answer clear questions of interest (e.g. does giving children more fruits and vegetables while changing nothing else lead to weight loss?; does eating breakfast regularly lead to weight loss?; etc.). The conduct of such trials may sometimes be expensive but can sometimes be only modestly costly if they are kept simple. However, it is difficult to... more »

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1 up votes
1 down votes
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(@skrenrich)

Goal 2: Reduce Human Disease

Clinical Trials & Duplicative Regulatory Standards

The initiation of clinical trials remains difficult, time-consuming, and costly. Repetitive institutional review board oversight is one of several obstacles to efficient clinical trial initiation and completion. New strategies for addressing duplicative regulatory standards are necessary to ease the initiation and completion of trials.

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5 net votes
6 up votes
1 down votes
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(@wheeze)

Goal 2: Reduce Human Disease

Behavioral Science in Asthma Clinical Research

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:

 

Will integration of behavior science in clinical research improve effectiveness of interventions for asthma associated with behavioral risk factors? 

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-5 net votes
8 up votes
13 down votes
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(@wheeze)

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?

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2 net votes
15 up votes
13 down votes
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(@nhlbiforumadministrator)

Goal 2: Reduce Human Disease

Towards Collaborative Funding of Clinical Trials

A way for clinical trial investigators to submit ONE application with ONE review and ONE funding decision, and the application would ask for funding from multiple funders (e.g. NHLBI and another IC, NHLBI and PCORI, NHLBI and AHA, NHLBI and CIHR, NHLBI and MRC).

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-1 net votes
8 up votes
9 down votes
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(@nhlbiforumadministrator1)

Goal 2: Reduce Human Disease

Comparison of CAC-based Strategy versus AHA/ACC Guidelines

There is a need for a randomized primary prevention trial comparing the effectiveness of cholesterol treatment strategies based on a high CAC score versus the AHA/ACC 10-year cardiovascular disease risk tool. Include cost-effectiveness as well as clinical effectiveness as endpoints.

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-8 net votes
4 up votes
12 down votes
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(@nhlbiforumadministrator)

Goal 2: Reduce Human Disease

Lung Transplantation

Although the majority of lung recipients experience significant health improvement, they also frequently face serious symptom distress, impaired physical functioning and poor quality of life due to post-transplant morbidity, such as chronic rejection, infection and multiple side-effects of immunosuppression. a) Conduct clinical trials of interventions designed to maximize clinicians' support of patients' self-management... more »

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1 up votes
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(@meaton)

Goal 2: Reduce Human Disease

Support for Cardiothoracic Surgery and Pediatric Heart Clinical Trial Networks

Continued and expanded support for the Cardiothoracic Surgical Trials Network (CTSN) and Pediatric Heart Network (PHN) is essential as both design, conduct, and analyze multiple, collaborative clinical trials that evaluate surgical interventions, and related management approaches for the treatment of cardiovascular disease. To date both networks have reported on and developed a portfolio of studies which need continued... more »

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108 net votes
151 up votes
43 down votes
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(@nhlbiforumadministrator1)

Goal 3: Advance Translational Research

Improving Drug Safety through Precompetitive Research

The lack of transparency in Pharma clinical studies and the incomplete knowledge of the effect of genetic profiles and pharmacological factors on drug toxicities are challenges in decreasing drug development costs and increasing drug safety.

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-4 net votes
13 up votes
17 down votes
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(@katherinek)

Goal 2: Reduce Human Disease

How can we increase the pharmaceutical clinical research of targeted therapies in pediatric PAH patients, including encouraging

Clinical research, especially randomized pharmaceutical clinical trials, poses many unique challenges compared to research in adult subjects. In pulmonary arterial hypertension, a disease characterized by high blood pressure of the lungs with increased pulmonary vascular resistance leading to right ventricular failure, there are 12 FDA-approved PAH-targeted therapies for adults. None of these medications are currently... more »

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76 up votes
10 down votes
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