SOLICITATION NOTICE
A -- Engine For Fast Execution of Clinical Trials (EFFECT)
- Notice Date
- 4/25/2012
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-ECB-HR-2013-20-SS
- Archive Date
- 6/1/2012
- Point of Contact
- Sara Stoops, Phone: 301-435-0329
- E-Mail Address
-
stoopssb@mail.nih.gov
(stoopssb@mail.nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- The National Heart, Lung, and Blood Institute (NHLBI) is seeking a Clinical Coordinating Hub (Hub) for a NHLBI Engine For Fast Execution of Clinical Trials (EFFECT). The purpose of this announcement is to provide a Presolicitation Notice for the release of Solicitation NHLBI-ECB-HR-2013-20-SS. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION. The Hub will be responsible for organizing a virtual network of approximately 40-50 Clinical Sites and executing one to three Clinical Trials in patients with serious pulmonary disease, especially patients requiring hospitalization for exacerbations of Chronic Obstructive Pulmonary Disease (COPD). Trials may start in the inpatient setting and continue in the immediate post-discharge period. The objective is to rigorously test the efficacy and/or effectiveness of treatments that have inadequate clinical trial evidence to support their confident use. This initiative will generate data that is urgently needed to inform the inpatient treatment of individuals experiencing acute exacerbations of COPD that require hospitalization. The trials of EFFECT may test medical and/or surgical interventions in Phase II or Phase III efficacy, effectiveness, or comparative effectiveness trials. Up to 5 foreign Sites may be included in the network. This organization will allow for considerable flexibility with regard to specific studies and for NHLBI oversight of study operations and budget. Each of the Clinical Sites recruited by the Hub will have a Principal Investigator responsible for the conduct of trials at the site. Trials will typically involve a total of approximately 500-700 subjects with severe exacerbations of COPD study wide. The Hub will coordinate and manage the conduct of the trials at the Clinical Sites and will report to NHLBI. Clinical Sites will also be responsible for collecting and shipping to the Hub high quality biospecimens as required to address study objectives. The Hub will support the development and maintenance of a clinical structure ready to execute trials in hospitalized patients with COPD exacerbations. This includes recruiting and training Clinical Sites, writing a Manual of Procedures, developing and maintaining core data collection forms and a data management system, developing and maintaining a 508 compliant study website, managing study boards and committees, monitoring study compliance, analyzing trial results, and preparing a final data set. 1)The NHLBI anticipates one award under the solicitation for a Hub. The Hub shall be experienced and highly competent in the coordination of complex studies involving patients with severe pulmonary diseases, especially COPD. 2)Key personnel of the Hub will have demonstrated expertise and leadership in biostatistics and clinical trial design and conduct as evidenced by a record of peer-reviewed publications. 3)Key personnel of the Hub will also have demonstrated experience in clinical trials and be board-certified and actively involved in the care and treatment of patients hospitalized with severe pulmonary diseases, especially COPD. This investigator should be actively involved in research involving pulmonary diseases. 4)The Hub will develop a core collection of forms and data elements appropriate for screening, enrollment, phenotyping, medical record abstraction, follow-up, and outcomes assessment of subjects enrolled in inpatient trials of therapies for acute exacerbations of COPD. The Hub will develop a data management system that provides for secure electronic transmission of data from the Clinical Sites, real-time range and error checking, quality assurance and control, reliable archiving of study data, timely generation of summaries and reports, and statistical analyses of trial data. 5)Offerors will propose two protocols involving approximately 500-700 subjects, to test the efficacy of medical interventions designed to prevent readmissions within 30 days in COPD patients hospitalized for an acute exacerbation. One trial protocol should be fully developed. The second protocol does not need to be fully developed, but should contain sufficient detail to allow evaluation of its scientific merit and public health impact. 6)The Hub will solicit ideas from the pulmonary research community at large regarding additional clinical trials in hospitalized patients with severe pulmonary diseases, especially COPD. 7)The Hub will present trial Protocols to an Independent Board of Experts (IBE), a Protocol Review Committee (PRC), and a Data and Safety Monitoring Board (DSMB); incorporate revisions recommended by the DSMB, and obtain approval of the NHLBI. 8)The Hub will provide expertise in working with the FDA to obtain approvals for new drugs and/or devices. 9)The Hub will be responsible for developing a plan for biospecimen collection by sites and storage at a central lab. 10)The Hub will develop, implement and maintain a Manual of Procedures detailing procedures for: a)study governance, including the selection of Clinical Sites representatives, decision-making, and responsibilities of the Steering Committee (SC); b)arrangements for meetings and teleconferences of committees and boards; c)identification and selection of Clinical Sites; d)fiscal arrangements and payments to Clinical Sites; e)plan for training and certification of Clinical Site personnel, including a schedule, identity of personnel conducting the training, printed and electronic materials, and other media as required; f)PRC and DSMB review and NHLBI approval of protocols; g)registration of approved Clinical Trial(s) with Clinicaltrials.gov; h)coordination of study activities; communications among study investigators and other staff; i)tracking of IRB approvals for the Clinical Sites and assessment of IRB-approved informed consent documents from each Clinical Site with respect to essential elements; j)biospecimen processing and storage and shipping of study materials; k)labeling and distribution of drugs; l)randomization of subjects and blinding with regard to treatment group assignment; m)data management and real-time reporting of enrollment by site and subject characteristics; n)quality control and assurance; o)discovery, analysis, and remediation of protocol violations and study problems; p)procedures for training and retraining of personnel; q)procedures for remediation or protocol modification; r)identification and reporting of adverse events and unanticipated problems; s)plans for site visits; t)reporting of data to NHLBI, IRBs, and the DSMB; u)interactions with regulatory agencies such as the FDA; v)analysis of data and dissemination of findings 11)The Hub will develop Section 508 compliant computer systems and software needed to collect data, transfer study data from the Clinical Sites to the Hub, and for storage, retrieval, and statistical analysis of data. 12)The Hub will 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 EFFECT program and contact information for each of the participating centers, a section for those wishing to participate as Clinical Sites, including eligibility criteria, application procedures and timeline, and information required from applicants, and a section for specific trials, which describes procedures whereby clinical researchers can propose trials to be conducted through EFFECT and b) a password-protected section for study documents and internal communications among the participating Clinical Site investigators, including the status of and current enrollment in ongoing trials, as well as a link to the NHLBI public web site. 13)The Hub will plan and coordinate meetings and teleconferences of the SC, PRC, DSMB, IBE, and subcommittees as necessary. 14)The Hub will develop a tracking system for Clinical Site IRB submission and review; maintain a file of consent forms from the Sites; and ensure IRB approvals at each Site for each protocol and for annual reviews, as necessary. 15)The Hub will conduct data quality/chart review site visits. 16)The Hub will provide data sets to the SC for preparation of publications of main trial results and perform statistical analyses of the main trial results. 17)The Hub will 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 10, 2012. This advertisement does not commit the Government to award a contract.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-ECB-HR-2013-20-SS/listing.html)
- Place of Performance
- Address: National Heart, Lung, and Blood Institute, Rockledge Drive, Bethesda, MD 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02731353-W 20120427/120426000132-633d7f0c895fb559e6e9148f1d9a5d3e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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