Showing 2 ideas for tag "approval"

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 »

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

Details on the impact of addressing this CQ or CC

• Increased number of novel therapeutics, diagnostics and devices in early phase clinical trials
• Increased impact in rare diseases and unmet needs
• Increased number of licensed IPs from academic centers

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

Voting

17 net votes
25 up votes
8 down votes
Active

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 »

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

Details on the impact of addressing this CQ or CC

Identifying a validated surrogate endpoint FDA approval of novel intervention for STEMI would potentially attract broad industry support to address this crucial health need.

Feasibility and challenges of addressing this CQ or CC

NHLBI could potentially bring together all of the data in NHLBI-sponsored trials along with those sponsored by industry to assess the validity of infarct size measured by different methods as a surrogate indicator of death and clinical MI complications, including heart failure. By working with the FDA on this project, the impact on regulatory review would be immediate. The major challenges will be integrating data from multiple studies and choosing statistical methodology that is acceptable to the FDA for validating a surrogate endpoint.

Name of idea submitter and other team members who worked on this idea Barry Coller

Voting

1 net vote
2 up votes
1 down votes
Active