The National Heart, Lung, and Blood Institute (NHLBI) is seeking a Clinical Coordinating Center (CCC) for a seven-year program, the NHLBI Clinical Trials Research Network for the Prevention and Early Treatment of Acute Lung Injury (PETAL Network). The purpose of this announcement is to provide a Presolicitation Notice for the release of Solicitation NHLBI-HR-14-01. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION.

The Network will develop and conduct randomized controlled clinical trials to prevent, treat, and/or improve the outcome of patients with or at risk for Acute Lung Injury (ALI). More than one trial will be conducted simultaneously and it is expected that multiple, complex trials will be completed during the course of the contract. The emphasis is expected to be on prevention and early treatments. The Network will consist of approximately eleven Clinical Centers (CCs), each with at least one other recruiting site, and a CCC. Each CC will have two principal investigators from one institution that represent (1) an intensive care unit clinician and (2) another clinical investigator, such as an emergency department clinician, with early access to patients at risk for lung injury. The CCs shall also include at least one other institution that will participate in enrollment and study conduct but not network leadership. Each CC will be expected to enroll a total of 220 subjects over 5 ½ years of a seven-year project.

The CCC will coordinate all aspects of the research and communication within the Network, including development of protocols, management and analysis of data, assurance of data quality, and statistical and clinical leadership. The CCC will be responsible for collecting and archiving biospecimens during the contract, and depositing the specimens in the NHLBI biorepository at the end of studies. The CCC will be expected to provide the technical leadership to advise the steering committee on the potential and proper techniques for biospecimen collection from critically ill patients that will be useful in developing longitudinal molecular phenotypes. This may be achieved by a subcontract to a commercial or academic entity.

Research conducted by this Network should utilize the most modern and flexible electronic data collection, transfer, decision support, and monitoring. Members of the Network will be encouraged to participate in a collaborative Institutional Review Board program to reduce the time and redundancy of protocol approvals and monitoring. As this is developed, the CCC will be responsible for communication with the Network of CCs.

1)The NHLBI anticipates one award under the solicitation for a CCC. The CCC shall be experienced and highly competent in the coordination of complex studies involving critically ill patients.
2)The PI of the CCC shall have demonstrated expertise and leadership in biostatistics and clinical trial design and conduct in critically ill patients.
3)The CCC co-investigator shall have demonstrated experience in clinical trials and be certified and actively involved in the care and study of pulmonary and critically ill patients, especially Acute Lung Injury.
4)Prepare final protocols for review by the Protocol Review Committee (PRC) and the Data and Safety Monitoring Board (DSMB).
5)The CCC shall develop plans for:
a.randomization of subjects,
b.preparation and distribution of protocols, manuals, and forms,
c.data collection, quality, completeness, confidentiality, and analysis,
d.training of the CCC and the CC staff in implementing protocols and data entry,
e.methods to audit site data accuracy and quality,
f.preparing and reporting of data and protocols to the SC, PRC and DSMB,
g.coordinating drug blinding and distribution, as necessary,
h.assisting with the development of efficient IRB reviews by the many CCs,
i.monitoring content of and IRB approval of informed consent forms,
j.assisting in preparation of final manuscripts of primary studies,
k.coordinating communications among the CCs and scheduling conference calls and meetings of trial committees, as needed,
l.organizing (and PIs will attend) meetings of the PRC and DSMB,
6)Experienced in working with the FDA to obtain approvals for new drugs and/or devices.
7)Responsible for developing a plan to lead biospecimen collection by sites and storage at a central lab.
8)Responsible for leading the CCs in the development of a more efficient IRB review process. This could be a collaborative IRB, a central IRB, or some other method that will increase efficiency of trial reviews while maintaining safety and quality.
9)Develop, in collaboration with the CCs, and distribute an Operations Manual detailing procedures for a) collection of data, entry, and transmission of data to the CCC and b) data quality control/assurance procedures.
10)Develop Section 508 compliant computer systems and software needed to collect clinical data at the bedside, to transfer clinical data from the CCs to the CCC, and for storage, retrieval, and statistical analysis of data.
11)Develop and operate a randomization system for each trial to ensure equal and unbiased distribution of patients into treatment groups.
12)Develop Section 508 compliant Network web sites (public and internal for the network) that include, but are not limited to, a) a description of the Network objectives, organization, procedures, protocols, and references to publications resulting from Network research trials, and b) a link to the NHLBI public web site.
13)Maintain and enhance the Network web sites including a portal for outside investigators to submit research ideas and comments.
14)Plan and coordinate meetings and teleconferences of the SC, PRC, DSMB, and subcommittees as may be necessary.
15)Develop a tracking system for the CC IRB submission and review. As available, review each CC's IRB-approved consent form for adherence to required elements. Maintain a file of the most current consent form from each CC. Ensure receipt of the CCs' IRB approvals for each protocol and for annual reviews, as necessary.
16)Conduct scientific site visits and data quality/chart review site visits.
17)Provide data sets to the SC for preparation of publications of main trial results. Conduct statistical analyses of main trial results.
18)Prepare final limited access data sets. The data sets shall include data with full documentation, prepared in accordance with NHLBI policies available at: http://www.nhlbi.nih.gov/resources/deca/policy.htm

This is not a Request for Proposal (RFP) and the Government is not committed to award a contract pursuant to this announcement. It is anticipated that the RFP will be available on FedBizOpps on or about May 18, 2012. This advertisement does not commit the Government to award a contract.