(@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 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
Active
(@gacdk0)

Goal 3: Advance Translational Research

Definitive Evidence of the Effectiveness of Pulmonary Rehabilitation

What is the clinical effectiveness of pulmonary rehabilitation in reducing hospital admissions and readmissions, improving health outcomes such as exercise tolerance and dyspnea, and positively impacting patient centered outcomes. Does this effectiveness vary based on the types of settings rehab is conducted in, urban vs rural environments, the components to the program, the timing of the program and the overall support ...more »

Voting

9 net votes
12 up votes
3 down votes
Active
(@nhlbiforumadministrator)

Goal 3: Advance Translational Research

ASCVD Risk and Treatment Options

There is little evidence about the best ways in which to effectively communicate atherosclerotic cardiovascular disease (ASCVD) risk to patients so that they clearly understand the potential benefits and harms of treatments in order to make informed decisions about their care. A shift toward shared decision-making and tailored treatment makes it imperative that effective risk communication strategies be developed and ...more »

Voting

-2 net votes
6 up votes
8 down votes
Active
(@nhlbiforumadministrator1)

Goal 2: Reduce Human Disease

Risk-benefit of oral hypoglycemic medication in type 2 diabetes

Is an increase in macrovascular endpoints outweighed by the benefit in microvascular end points in new oral type 2 diabetes drugs?

 

It would go against the current regulatory paradigm in type 2 diabetes. Although drug companies do not like the current paradigm, they would prefer to go back to the pre-rosiglitazone state of affairs, in which new drugs had only to prove that they lowered blood glucose and HbA1c.

Voting

-7 net votes
9 up votes
16 down votes
Active
(@dayam0)

Goal 1: Promote Human Health

Non-opioid management of pain

The use of opioid agents has increased dramatically in the United States. Prescription drug overdoses now account for more deaths than traumatic injuries in the 1-44 age group. There is a need for more high level evidence to target optimal pain management strategies in the acute (ED) and non-acute settings (office practice) especially for chronic disorders such as low back pain, headaches, fibromyalgia, acupuncture etc. ...more »

Voting

6 net votes
6 up votes
0 down votes
Active
(@nhlbiforumadministrator1)

Goal 3: Advance Translational Research

Integrated Clinical Guideline on Comorbidities in Primary Care

The development of systematic evidence reviews (SER) that provide the evidence that partner organizations can use to develop an integrated clinical practice guideline for use by primary care providers for the treatment of patients with single and multiple conditions for the primary and secondary prevention of heart, lung, blood, and sleep (heart, lung, blood, sleep) diseases.

Voting

1 net vote
12 up votes
11 down votes
Active
(@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 »

Voting

108 net votes
151 up votes
43 down votes
Active
(@collerb)

Goal 3: Advance Translational Research

Validating surrogate/intermediate clinical outcome endpoints for ST segment elevated myocardial infarction (STEMI)

The introduction of troponin assays has changed the criteria for myocardial infarction (MI), with much smaller myocardial damage now classified as an MI. Since to date, the FDA has not approved new agents based on their decreasing size of an MI, regulatory approval has required endpoints like death or heart failure that require large numbers of patients and long periods of time. Thus, it is difficult to attract industry ...more »

Voting

1 net vote
2 up votes
1 down votes
Active
(@media0)

Goal 3: Advance Translational Research

Building a bridge - new approaches to dissemination

There is a need to fundamentally rethink the approach to translation and dissemination of clinical trial results. The current approach relegates dissemination as a side effect to the end of a trial and does not require sufficient funds be set aside to conduct adequate outreach. As a result, it takes up to 17 years for the results of trials to be adopted and used in everyday practice. It is time for a new model which re-prioritizes ...more »

Voting

2 net votes
4 up votes
2 down votes
Active
(@nhlbiforumadministrator1)

Goal 2: Reduce Human Disease

US-based Clinical Development of Innovative Medical Devices

Though innovative medical devices are often conceived of and developed in the US, US consumers are frequently the last to benefit. Innovators frequently go to market first in Europe and are now moving toward emerging countries, delaying the medical benefits available to the US population. Can the NHLBI and FDA’s CDRH, working together as sister agencies, develop strategies such as funding opportunities or collaborative ...more »

Voting

4 net votes
19 up votes
15 down votes
Active