MODIFICATION
A -- Systolic Blood Pressure Intervention Trial (SPRINT) ?C Coordinating Center
- Notice Date
- 10/3/2007
- Notice Type
- Modification
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- 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, MD, 20892-7902, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-NIH-NHLBI-HC-SS-09-04
- Response Due
- 10/31/2007
- Archive Date
- 10/31/2007
- Point of Contact
- Paul McFarlane, Chief, ECA/WHI Branch, Phone 301-435-0345, Fax 301-480-3430
- E-Mail Address
-
pmcfarlane@mail.nih.gov
- Description
- The NHLBI is seeking small businesses with the capability to serve as a Coordinating Center (CC) for a new nine-year multicenter clinical trial, Systolic Blood Pressure Intervention Trial (SPRINT). SPRINT is a randomized, multicenter clinical trial testing the effects of intensive lowering of systolic blood pressure (SBP) on preventing cardiovascular disease (CVD). Approximately 7,500 participants will be randomized into either the lower SPB goal of <120 mmHg (intensive treatment group) or the standard SPB goal of <140 mmHg (control group). Participants will be 55 years or older with SPB >130 mmHg and at least one additional CVD risk factor. Only two high risk groups will be excluded. Those patients with diabetes and those who have had a stroke because they are the target groups of other ongoing NHLBI and NINDS trials that are testing a lower BP goal. SPRINT will focus on three other high risk groups: patients with clinical CVD other than stroke, patients with stage 3 chronic kidney disease (CKD), and patients without clinical CVD who have other CVD risk factors such as low levels of HDL. In SPRINT, there will be a subgroup of 3,500 people with stage 3 CKD (estimated glomerular filtration rate of 30-59 mL/min/1.73 m2). The primary composite endpoints will be CVD mortality and non-fatal MI, stroke, and heart failure. Several secondary outcomes will be examined, such as markers of renal functioning in non-CKD participants, quality of life, and cost-effectiveness. It is possible that the study may be expanded to include additional secondary clinical endpoints, or additional treatment strategies to achieve the standard and lower SBP treatment goals. There will be a one year protocol development phase, followed by the recruitment of participants over a 2 year period. Participants will be followed for a total of four to six years. Post follow-up there will be a two year period for close out, analysis, reporting, and dissemination. Data to be collected includes demographics, medical history, physical examinations, medications, results of clinical laboratory tests and electrocardiograms (ECGs), as well as psychosocial, economic, and lifestyle questionnaires and data. SPRINT will include 4 to 6 Clinical Center Network (CCN) hubs, with approximately 30-45 clinical sites per hub, which will be solicited under a separate request for proposals (RFP). Depending on the final number of CCN hubs and clinical sites, data is anticipated to be collected from 120 to 180 clinical sites, with each CCN hub enrolling a total of 1,250 to 1,875 participants. In addition, it is anticipated that the CC will subcontract for services for the following additional components of SPRINT: a Drug Distribution Center (DDC), an ECG Reading Center, and a Central Laboratory. One or more substudies that enhance the scientific value of the parent trial may also be performed in this program. Substudies may be conducted at all CCNs or at only a subset of the CCNs. Substudies will be selected and designed by the Ancillary/Substudy Proposals Subcommittee (ASPS), which will be established by the SPRINT Steering Committee. The Steering Committee (SC) will be composed of the CCN investigators, Coordinating Center representatives, NHLBI and NIDDK representatives, and other experts as needed. The SC chair will be appointed by the NHLBI director. The SPRINT Coordinating Center will: 1) be responsible for the statistical design of the study and provide biostatistical support for protocol development, including power and sample size calculations and simulations; for randomizing study subjects, for study monitoring, and for the management and analysis of study data; 2) develop operational and analytical methodology; provide administrative guidance, oversight, and support for SPRINT as a whole; 3) coordinate protocol writing activities, including protocol drafting and finalization; develop, design, and distribute study forms and a manual of operations; ensure that the provisions of the manual of operations are carried out by the CCNs and the clinical sites; 4) establish the Drug Distribution Center (DDC) and two core laboratories: the Central Laboratory and the ECG Reading Center; the DDC will package, label, and dispense drugs according to the study protocol and will also monitor compliance and provide data to the CC for further analyses; the Central Laboratory will arrange for the analysis of blood and urinary measurements, provide interpretation of blood measurements, and collect and store blood samples for biomarker and DNA analysis; the ECG Reading Center will provide a central interpretation laboratory of resting ECG; core laboratories will be responsible for developing and distributing specific measurement procedures, timely data gathering, analysis under the leadership from the CC, and providing data to the CC for central analyses; 5) maintain quality control at participating Clinical Center Networks (CCN), and monitor their performance status; promote interactions among the CCNs, coordinating study activities among the CCNs and core laboratories, and assuring uniformity of study activities at all sites; train CCNs and core laboratories in standardized protocol implementation and data collection; provide rapid feedback to the CCNs and core laboratories on the quality of data submitted and proposed corrections; conduct periodic visits to each CCN in order to monitor and assure high performance throughout the trial; 6) make travel arrangements and reimbursement to the Steering Committee chair and to the Data and Safety Monitoring Board (DSMB) members; 7) coordinate, plan, make arrangements for, and participate in the meetings of the Steering Committee and its subcommittees and of the DSMB and other meetings related to the conduct of the overall trial; 8) facilitate communications among all organizational study components during each phase of the trial, including the Protocol Review Committee (PRC), the Data and Safety Monitoring Board (DSMB), and trial-wide subcommittees, such as the ancillary/substudy, mortality/morbidity, operational, publications, and adherence subcommittees; prepare and distribute minutes and reports of the Steering Committee, Executive Committee, PRC, and DSMB meetings, ensuring the quality and accuracy of data collection and report content; 9) establish and maintain a computer system, secure database, and software needed for the storage and analysis of study data (including blood samples and ECGs) collected from up to 120-180 separate clinical sites; also provide for the central interpretation of quality of life and costs data collected on subsamples of participants; 10) develop and maintain a study web site for the distribution of SPRINT information, documents, and forms to the CCNs; develop and maintain a public web site that provides information about SPRINT for the lay public; 11) prepare and distribute periodic technical and statistical reports to the participating CCNs, the project officer, the contracting officer, and others identified as key partners by the project officer; 12) review, at least weekly, study plans, procedures, activities, and data to ensure the scientific validity and clinical relevance of the trial and the protection of human subject safety and privacy, addressing such issues as recruitment progress and certification of new clinical sites; 13) monitor end point results, morbidity and mortality data, and adverse event reports for patterns of safety or toxicity that may warrant changes in the study; and 14) design and implement a plan for study closeout, analysis, and dissemination, including final data collection, verification, analytical support for scientific writing groups, publication of study results, and plans for the investigators?? dissemination of study results. The CC will frequently need to make complex and rapid decisions and assist the study leadership and the DSMB in their decision-making process. These decisions will often be based on medical information obtained from the clinics and developments in the scientific literature and other sources of information, such as the FDA. Therefore, CC staff will need to be highly experienced, with strong medical and scientific qualifications and credibility, and have specialized experience relating to hypertension, clinical cardiology, and nephrology. The CC must have biostatistical and information technology expertise, including the ability to analyze a large volume of physiologic, quality of life, economic, and medical morbidity and mortality data, and to develop and maintain a complex website and computer system. CC staff must be experienced coordinating several long term, complex, large scale, multi-site clinical events trials lasting more than four years. This experience should include managing subcontracts with a DDC or core laboratories. The medical monitor for the CC should be board certified in internal medicine with substantial experience in the clinical management of hypertension, and have significant experience in large scale multi-site events clinical research trials. The CC must develop highly productive working relationships with the CCNs, core laboratories, academic researchers, NHLBI Project Office, advisory groups (e.g., DSMB), and clinical sites. This is not a request for proposals (RFP) and the Government is not committed to award a contract pursuant to this announcement. Small business concerns that believe their organizations possess the capabilities necessary to undertake this study should submit complete documentation of their capabilities to the Contracting Officer at the address below. Include the name and telephone numbers of a point of contact. When submitting this information, please reference this notice number. We ask that the capabilities statement not exceed 14 single sided or 7 double sided pages in length. The NAICS code for this project is 541712, formerly 541710. Paul D. McFarlane, Contracting Officer, Office of Acquisitions, DERA National Heart, Lung, and Blood Institute, NIH, DHHS 6701 Rockledge Drive, Rockledge II, Room 6126, MSC 7902 Bethesda, MD 20892-7902 For overnight deliveries use zip code 20817, no MSC is required. The capabilities statement shall include 1) the total number of employees, 2) the professional qualifications of scientific, medical expert, and technical personnel in accordance with the above outline requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, and 4) an outline of previous long term, multicenter events clinical trials in which the organization and the proposed personnel have participated; and any other information considered relevant to this program. Do not include budget information. The information provided must also establish the organizations' status as a small business. Two (2) copies of the capabilities statement must be received at the address in this announcement. If this program is approved for implementation and it is determined to be a small business set aside, then a competitive RFP will be set aside for small business concerns. When released, the RFP will be available on the Federal Business Opportunities (FEDBIZOPPS) website. The following criteria will be used to evaluate the capability statements. Both of these criteria are weighted equally. 1. PERSONNEL AND EXPERIENCE: Documented training, experience, and expertise of the professional, technical, and administrative staff with experience pertinent to the development and implementation of clinical events trials of similar complexity, duration, and size, including trials evaluating the prevention and treatment of hypertension and other cardiovascular diseases. This includes knowledge of and experience with statistical analyses, data collection, management, monitoring, quality control, management of medication side effects and adverse reactions to drug therapy, data analysis and reporting, including analysis of genetic data. 2. ORGANIZATIONAL EXPERIENCE AND FACILITIES: Adequacy and availability of the organizational and administrative structure to participate in a complex, large, long-term, multicenter clinical events trial, and organizational commitment to the program. Prior successful participation by the organization in multicenter clinical trials of similar complexity, both in the collection of data from multiple clinical sites, as well as experience in monitoring the quality and timeliness of such data. Availability and adequacy of the facilities and resources necessary for conducting study coordination, data management and analysis, including computer hardware, software, and other equipment in order to successfully implement the requirements of the contract.
- Record
- SN01427708-W 20071005/071003223308 (fbodaily.com)
- Source
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