A -- STATISTICAL AND DATA COORDINATING CENTER (SACCC)

Notice Date

May 1, 2001

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Contract Management Branch, 6700-B Rockledge Drive, MSC 7612, Bethesda, MD, 20892-7612

ZIP Code

20892-7612

Solicitation Number

Reference-Number-I-0205

Response Due

May 17, 2001

Point of Contact

Ross Kelley, Contract Specialist, Phone (301) 402-2234, Fax (301) 480-5253, Email rk17a@nih.gov

E-Mail Address

Ross Kelley (rk17a@nih.gov)

Description

The National Institute of Allergy and Infectious Diseases (NIAID), NIH is seeking businesses with the capability of providing a Statistical and Data Coordinating Center (SACCC), which will provide clinical trial design and implementation expertise, statistical leadership, and technical, administrative and logistical support, for the activities of the Inner City Asthma Consortium. The Consortium, which will be awarded under a separate contract, is a network of basic scientists and clinical investigators, under the leadership of a Principal Investigator, will perform clinical trials to evaluate the safety and efficacy of promising immune-based therapies for reducing asthma severity and preventing disease onset in minority children residing in inner cities of the United States. The clinical trials will be accompanied by studies to investigate the mechanisms underlying such therapies, and other studies to develop surrogate/biomarkers to measure asthma stage, progression, and therapeutic effect. The sources being sought here are only for a SACCC to support this Consortium. This announcement is not a request for proposals. There is no RFP available and the government is not committed to award a contract pursuant to this solicitation. Responses should not include cost or pricing information. The SACCC shall be involved in assisting investigators in their development of proposals, from concepts for trials to detailed protocols, through the final data analysis and reporting of results. The offeror must provide documentation of its capabilities to perform the duties described below. 1. Provide statistical leadership and clinical trial design expertise for assisting in the development of protocols and design of clinical trails 2. Provide leadership and expertise in the implementation, refinement and monitoring of clinical trials 3. Provide statistical leadership and design expertise in the development and implementation of proposed research designs for associated mechanistic studies and surrogate/biomarker studies. 4. Provide technical and administrative support to NIAID for review and approval of proposed concepts, proposed clinical trials and proposed research designs for mechanistic and biomarker studies. 5. Design and conduct interim and final statistical analyses of study data, prepare reports on the status of clnical trials and mechanistic and biomarker studies, and participate in the publication of scientific manuscripts. 6. Establish and administer systems for collection, management, quality assurance and reporting of study data 7. Conduct clinical site monitoring and training 8. Provide support for regulatory functions associated with Investigational New Drug applications, including, for example, a system for reporting adverse events to the SACCC that is available 24 hours a day. 9. Establish and manage a system for distribution and quality control of therapeutic agents used in the Consortium trials, and of biological samples 10.Coordinate and provide statistical, technical, administrative and logistical support for the activities of the Consortium Executive Committee, which provides advice on the scientific directions of the research program. 11.Coordinate and provide statistical, technical, administrative, and logistical support for the activities of the Data and Safety Monitoring Board, an independent body appointed by NIAID to monitor the safety of Consortium clinical trials 12.Provide statistical leadership and protocol design expertise for design, implementation, refinement and monitoring of clinical studies to identify the mechanisms involved in the immunopathogenesis of asthma in inner-city children. For purposes of responding to this sources sought, the offeror shall assume that all the participants in the clinical trials and clinical studies will be children residing in inner cities in the United States. The Consortium will operate for 6 years. Each year, there will be three clinical trials, with associated mechanistic and biomarker studies, involving a total of five clinical site, and a total of 500 study participants each year. In addition to the duties described above, the SACCC will be responsible for monthly accrual and site registration reports, monthly adverse events reports, and quarterly status, statistical and work report on concept, protocol, and mechanistic and biomarker study development. The Consortium Executive Committee will be composed of approximately 11 non-Federal members, including the SACCC Principal Investigator. The SACCC Principal Investigator and 2-4 additional SACCC staff will attend each meeting; the Committee will meet 3 times per year and have monthly conference calls. The DSMB will consist of approximately 8 individuals and will meet once a year and have quarterly conference calls. It is anticipated that the SACCC will be led by a Principal Investigator over the 7 year term of the contract. In addition to the Principal Investigator, the SACCC will provide statisticians, programmers, clinical site monitors, regulatory affairs supervisors, and pharmacists. The SACCC will also provide physicians or other individuals with asthma-specific medical expertise. The offerors must document their capacity for scientific, regulatory, technical and administrative leadership of the SACCC, including expertise in asthma-specific clinical trial design, clinical protocol implementation, leadership skills and asthma specific medical expertise. The offerors must also demonstrate managerial ability to successfully manage the project. They must also document the experience of the organization in managing projects of similar complexity and scope. See Numbered Note 25.

Web Link

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Record

Loren Data Corp. 20010503/ASOL010.HTM (D-121 SN50K8F3)