Translation of Fundamental Research Findings into Clinical Treatments for Heart, Lung, and Blood Diseases

Scientific Opportunity

Fundamental research studies in cells, tissues, and animal models and investigations of biomarkers and functional genomics have all greatly expanded understanding of the pathogenesis of many heart, lung, and blood diseases and have also provided a range of potential new approaches for their prevention and treatment.

The NHLBI’s Recovery Act investment provides an excellent opportunity to stimulate translational research and thereby hasten the transition of research findings into clinical practice.  The NHLBI awarded Recovery Act-funded grants in the following program areas:

1) Stage I of the NHLBI Translational Research Implementation Program (TRIP)
The intent of the two-stage TRIP is to accelerate the translation of fundamental research ideas into proof-of-concept efficacy testing in patients. The two-year Stage I TRIP awards support preliminary studies that culminate in the development of ready-to-conduct clinical trials. The ARRA-funded grants will support the activities required to design clinical trials to evaluate safety and efficacy of new modalities to treat and prevent heart, lung, and blood diseases based on promising ideas that have emerged from basic research.  For the Stage II TRIP, the NHLBI will use regularly appropriated funds to support the most meritorious trials developed in Stage I.

2) Phase II Clinical Trials Program of Novel Therapies for Heart, Lung, and Blood Diseases
This program is supporting Phase II clinical trials of novel therapies and diagnostic strategies for heart, lung, and blood diseases that offer the potential to change clinical practice and are ready to be tested in patients.  It also encourages innovative clinical-trial designs.  The supported research is expected to result in high-quality data that will lead to efficacy or Phase III trials.  Only interventions and strategies that offer high promise for modifying current treatments or diagnostic approaches, or for altering the course of a disease will be assessed in this program.

3) Ancillary Studies Program
This program is supporting research that leverages ongoing, large clinical studies to enhance understanding of the mechanisms involved in the pathogenesis and treatment of heart, lung, and blood diseases.  Clinical trials are designed to answer important clinical questions and are therefore not usually structured to permit detailed investigations of underlying disease mechanisms or of the behavioral or economic consequences of a disease, and standard grant mechanisms are typically not flexible enough to enable timely initiation of ancillary studies.

Last Updated February 22, 2010