Clinical Trials in ALI

1.

 
1. In general, the mission of NHLBI is to conduct research focused on heart, lung, and blood disorders. Are studies focusing on ventilated patients with lung injury likely to provide the maximum value for research in the intensive care unit? Is there another patient population that should be considered?
2. Would involvement of other hospital departments expand the scope or significance of possible trials? For example, would emergency department collaboration allow trials that prevent development of ALI in patients with risk factors for the syndrome? Are there other departments or clinical specialties that could enable novel and important trials?
3. What are 3 highest priority research questions for an NHLBI-supported network of pulmonary and critical care investigators?
4. Identify methods to select the most important studies for improving the care and treatment of critically ill patients. Currently, studies are developed by a steering committee of network investigators and reviewed for science by an independent Protocol Review Committee and for safety by a Data and Safety Monitoring Board. Opportunity, feasibility, and preliminary studies are important considerations for Network studies. Should there be an additional peer panel of experts not involved with the network that prioritize studies for development by a network? Consider effects on timeliness of study commencement that an additional review might impose.
5. Is the transfer of basic science results too slow so that the newest ideas are not examined in NHLBI networks? What is needed to facilitate this transfer?
6. NHLBI clinical trials networks are required to conduct multiple trials simultaneously and therefore may be operating at their maximal capacity to enroll patients. How might new ideas for trials be accommodated given this general requirement for multiple simultaneous studies?
7. Recruitment into clinical trials usually lags behind projections. Identify ways to improve and motivate enrollment in clinical trials. Consider involvement of community hospitals. If addition of recruitment sites is considered, suggest ways to provide a selection procedure that is fair, timely, and can insure quality.
8. Discuss the potential role of electronic medical records. Comment on feasibility and suggestions for use in ICU research.
9. (Optional) Provide name and affiliation; make any additional comments/suggestions.
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