Showing 7 ideas for tag "regulatory"
(@mmarques) kudos icon +

Goal 2: Reduce Human Disease

The role of Extracorporeal Photopheresis (ECP) in the prevention and treatment of rejection of heart and lung transplants

According to the ISHLT, more than 4,000 patients undergo a heart transplant each year, and almost 4,000 receive single or double lung transplants. Their prognosis depends heavily on the avoidance of rejection, which claims the majority of their lives. For heart transplant recipients, the median survival is 11 years, while for lung transplant recipients, it is approximately 5 years. The current most common anti-rejection... more »

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80 net votes
102 up votes
22 down votes
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(@nhlbiforumadministrator) kudos icon +

Goal 3: Advance Translational Research

Facilitating the translation of discovery science into proof of concepts in preclinical models

What steps can the research community take to facilitate the translation of discovery science into proof of concepts in preclinical models and in humans for diagnosis, prevention, and treatment?

• Current regulatory environment
• Lack of communication between discovery and clinical research worlds
• Lack of training
• Getting industry, academia, and NHLBI to partner; and the business model to make it happen.
• Limited... more »

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17 net votes
25 up votes
8 down votes
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(@efimov) kudos icon +

Goal 3: Advance Translational Research

NHLBI Cardiovascular Engineering Strategy

Most impressive and impactful advances in CV diagnostics and therapies came in the last 50 years from CV engineering, including implantable devices and imaging technology. CV engineers are developing next breakthrough technology including tissue engineering and flexible electronics. However, organizational structure of NIH does not have an entity responsible for strategic development of CV engineering. NIBIB does not... more »

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8 net votes
17 up votes
9 down votes
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(@nhlbiforumadministrator1) kudos icon +

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 »

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4 net votes
19 up votes
15 down votes
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(@skrenrich) kudos icon +

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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(@societyforvascularsurgery) kudos icon +

Goal 2: Reduce Human Disease

Data from regulatory studies a barrier to evidence-based medicine

Alignment of regulatory, healthcare, and research arms of the government is poor. There is a need to improve the design, quality and usefulness of data from regulatory studies to address major clinical questions and also to facilitate scientific inquiry. This is a barrier to evidence based medicine and improved treatments.

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2 net votes
3 up votes
1 down votes
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