Goal 3: Advance Translational Research

Submitted by (@rebecca.lehotzky)

Obstacles to the timely completion of clinical trials

There are numerous obstacles to the timely completion of trials, and there is a crisis in US enrollment rates. Overcoming barriers to timely completion of clinical trials would have a profound impact on accelerating research translation to improving health. Clinical investigations are necessary to advance the prevention, diagnosis, treatment and cures of human disease. The rate of basic scientific discovery has overwhelmed ...more »

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Goal 2: Reduce Human Disease

Submitted by (@nhlbiforumadministrator1)

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.

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Goal 3: Advance Translational Research

Submitted by (@mtothbsf)

Substituting scientific-medical insight before profit in drug development

Since the Pure Food and Drug Act of 1906 and the rise of the FDA, the US federal government has directly inserted itself into medical research, primarily from a business perspective. The Orphan Drug Act of 1983 monetarily incentivized the process for rare diseases, but for ultra-rare diseases of < 1,000 patients, it does not work. Successful drugs for rare diseases have enormous price tags to compensate their development ...more »

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Goal 2: Reduce Human Disease

Submitted by (@nhlbiforumadministrator)

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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Goal 2: Reduce Human Disease

Submitted by (@meaton)

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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Goal 2: Reduce Human Disease

Submitted by (@wheeze)

Heterogeneity in Asthma Phenotypes

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: Asthma appears to be due to heterogenous etiologies.  To better characterize the various phenotypes and potential etiologies, it would be important to create more epidemiologic and biomarker focused databases, which could ...more »

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Goal 3: Advance Translational Research

Submitted by (@collerb)

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 »

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Goal 1: Promote Human Health

Submitted by (@nhlbiforumadministrator1)

Transforming Transplantation with RISC

What is necessary to reprogram the immune system to improve transplant outcomes of hearts, lungs, and hematopoietic cells? While NIAID is a major funder of immunology research, we are a major contributor to stem cell research. Our resources could be combined, where NIAID would support this approach for autoimmune diseases, and we would support work in tolerance for transplants. If the NCI also wants to collaborate on ...more »

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