Clinical Coordinating Center for NHLBI Acute Respiratory Distress Syndrome Clinical Trials Research Network (ARDSNet)

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION. The National Heart, Lung, and Blood Institute (NHLBI) is planning to negotiate and award an additional option, without providing for full and open competition, to the Massachusetts General Hospital (MGH) Contract HHSN268200536179C to continue as the ARDSNet Clinical Coordinating Center (CCC). The purpose of this announcement is to provide a Presolicitation Notice as a follow-up to the sources sought synopsis (HHS-NIH-NHLBI-RDSS-HR-14-08), which was posted within FedBizOpps on May 23, 2013. The intended procurement is classified under NAICS code 541712 with a Size Standard of 500 employees. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION. Proposals are not being requested and a written solicitation will not be posted to FedBizOpps. The NHLBI is seeking to negotiate a new eight and a half (8 ) month option with MGH to continue serving as the ARDSNet CCC for this ongoing program. The ARDSNet is currently a collection of 12 Clinical Centers (CCs) and one CCC that conducts definitive clinical trials that can improve the outcomes of patients with Acute Respiratory Distress Syndrome (ARDS). The CCs are completing enrollment in their final protocol: Statins for Acutely Injured Lungs with Sepsis (SAILS). This study will test the efficacy of rosuvastatin in resolving Acute Lung Injury (ALI) and ARDS in patients with ALI/ARDS from an infectious etiology. The NHBLI anticipates that the CCC will be needed for Phase II of the ARDSNet until June 30, 2014 to achieve the recruitment goals of the trial. The ARDSNet is governed by a steering committee (SC) composed of principal investigators from the CCs and the CCC along with the NHLBI Contracting Officer's Representative. The SC selects, designs, and recruits patients into the protocols. The CCC oversees all aspects of network governance and conduct: it manages all committees, maintains public and private websites, provides all needed statistical expertise for design and analysis of studies, provides all support needed to conduct studies including preparation of case report forms, training of all clinical staff, daily assistance with protocols, and safety oversight. NHLBI has a Data and Safety Monitoring Board (DSMB) for advice on study continuation in accordance with decision guidelines that are a part of the clinical trial protocol. The CCC coordinates all SC activities and prepares all reports for the DSMB including communications about safety and planned interim analyses. The CCC prepares all final data reports and plays a major role in the preparation of manuscripts for peer reviewed journals. MGH will continue to serve as the ARDSNet CCC and will be responsible for coordination of all aspects of the ARDSNet from October 16, 2013 - June 30, 2014, including oversight and management of the conduct and analysis of the final protocol, SAILS, maintenance of standard operating procedures, public and private web sites, and coordination of all ARDSNet meetings and committees. The CCC will be responsible for the preparation and presentation of interim data reports to the DSMB, analysis of data, and assisting in the preparation of reports and manuscripts for publication of trial results. The CCC is expected to fulfill the following: 1)Experienced and highly competent in the coordination of complex studies utilizing statins in critically ill patients. 2)The Principal Investigator of the CCC will have demonstrated expertise and leadership in biostatistics and clinical trial design and conduct in critically ill patients. 3)The CCC co-investigator will have demonstrated experience in clinical trials and be certified and actively involved in the care and study of pulmonary and critically ill patients with Acute Lung Injury. 4)Ability to prepare final protocols for review by the DSMB. 5)The CCC will continue to oversee: 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.audit site data accuracy and quality, f.preparation of data from 1,000 SAILS patients for the DSMB, g.coordination of drug blinding and distribution, as necessary, h.coordination of collection of biospecimens required by the protocol, i.coordination with NHLBI BIOLINCC to transfer and retrieve ARDSNet biospecimens, j.monitor content of and IRB approval of informed consent forms and protocol modifications, k.perform all required statistical analyses of SAILS and other sub-studies as needed, l.assist in preparation of final manuscripts of SAILS study, m.coordinate communications among the CCs and scheduling conference calls and meetings of trial committees, as needed, n.organize and attend meetings of the SC and DSMB 6)Maintain a randomization system for SAILS to ensure equal and unbiased distribution of patients into treatment groups. 7)Maintain Section 508 compliant Network web sites (public and internal for the network) 8)Plan and coordinate meetings and teleconferences of the SC, DSMB, and subcommittees, as may be necessary. 9)Conduct scientific site visits and data quality/chart review site visits. 10)Provide data sets to the SC for preparation of publications of main trial results. Conduct statistical analyses of main trial results. This synopsis is not a request for competitive proposals and the Government is not committed to award a contract pursuant to this announcement. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by 3:00 pm eastern time on July 17, 2013 and must reference number NHLBI-HR-14-08. Responses shall be submitted electronically to Scott Bredow, Contracting Officer, at bredowsa@nhlbi.nih.gov. Fax responses will not be accepted.