Notice Number: NOT-HL-11-113

Key Dates
Release Date: July 29, 2010
Response Date: September 10, 2010

Issued by
National Heart, Lung, and Blood Institute (NHLBI) (www.nhlbi.nih.gov)

Purpose

This Notice is a Request for Information (RFI) for ideas to update and improve the structure of a National Heart, Lung and Blood Institute (NHLBI)-supported clinical research network of pulmonary and critical care investigators and to seek research ideas that have the most promise to improve outcomes in the intensive care unit. 

Background

NHLBI has supported the Acute Respiratory Distress Syndrome Clinical Trials Network (ARDSnet) since 1994.  The Network has consisted of groups of clinical centers and a clinical coordinating center that together selected and designed trials, recruited patients, and published results.  There have been three separate peer-reviewed Requests for Proposals (RFPs) that established, expanded, and/or renewed the ARDSnet. 

A recent NHLBI workshop has recommended that a continued effort in clinical trials in ALI/ARDS is warranted (http://www.ncbi.nlm.nih.gov/pubmed/20224063?dopt=Citation).  It is widely recognized, however, that clinical trials are labor intensive and time consuming and the burden may be escalating.  The Institute of Medicine has published an analysis of NCI clinical trials network (http://www.iom.edu/Reports/2010/A-National-Cancer-Clinical-Trials-System-for-the-21st-Century-Reinvigorating-the-NCI-Cooperative.aspx) and suggested a number of improvements for efficiency and impact.

Information Requested

NHLBI requests input on new approaches to clinical trials that might be incorporated into a network, opinions on whether the scope of research questions previously addressed by ARDSnet should change, how input from the community and basic science might be fed into a network, and identification of the most important research questions that can improve patient outcomes in the intensive care unit.

This RFI invites the scientific community, health professionals, patient advocates, and the general public to provide comments and suggestions on the following issues.  It is not necessary to answer all questions below.  Please provide input on questions of interest.

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. Provide up to 3 ideas for research questions of the highest priority for NHLBI support that would require the collaboration of a network of pulmonary and critical care investigators. 
3. Comment on whether involvement of other hospital departments would expand the scope of possible trials or increase the significance of trials.  For example, would emergency department involvement 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?
4. Identify methods to select studies of the highest importance to the care and treatment of critically ill patients with heart, lung or blood disorders.  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.  Should there be an additional peer panel of experts not involved with the network that prioritize studies for development by a network? 
5. Comment on the transfer of new basic science findings into clinical trials.  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 almost always lags behind projections.  Identify ways to improve and motivate enrollment in clinical trials.  If addition of recruitment sites is considered, suggest ways to provide a selection procedure that is fair, timely, and can insure quality. 
8. Comment on the feasibility and advisability of involving community hospitals in clinical trials in critically ill patients.  Consider effects on quality and fairness as above.
9. Discuss the potential role of electronic medical records.  Specific comments about their feasibility and suggestions for use in ICU research are welcome.

Responses

To respond by September 10, 2010, please complete and submit the form on line at: http://www.surveymonkey.com/s/TRF6CRN

Confidentiality

This RFI is for planning purposes only and should not be construed as a solicitation for applications or proposals and/or as an obligation in any way on the part of the United States (U.S.) Federal government.  The Federal government will not pay for the preparation of any information submitted and/or for the government's use of that information.  Additionally, the government cannot guarantee the confidentiality of the information provided.

Responses to this RFI are voluntary and may be anonymous.  Any identifiers (e.g., names, institutions, e-mail addresses, etc) will be removed when responses are compiled.  Only the processed, anonymized results will be shared internally with scientific working groups convened by the NIH, as appropriate. Proprietary, classified, confidential, or sensitive information should not be included in your response.  The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). 

Inquiries

Questions about this request for information may be directed to:

Andrea L Harabin, Ph.D.
Program Director
Critical Care and Acute Lung Injury
Division of Lung Diseases
National Heart, Lung, and Blood Institute
Two Rockledge Centre, Room 9104
6701 Rockledge Drive
Bethesda, MD  20892-7940
Phone: (301) 435-0222
E-mail: andrea.harabin@nih.gov

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