SOURCES SOUGHT
A -- Systolic Blood Pressure Intervention Trial (SPRINT) ?C Clinical Center Networks
- Notice Date
- 10/1/2007
- Notice Type
- Sources Sought
- 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-09-05
- 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 Clinical Center Network (CCN) for a new nine-year multi-center clinical trial, Systolic Blood Pressure Intervention Trial (SPRINT). SPRINT is a randomized, multi-center 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. It is anticipated that there will be approximately 4-6 CCN hubs with approximately 30-45 clinical sites per hub. Clinical sites will be medical facilities or individual practices that will be involved in the evaluation, enrollment, and treatment of patients in the trial. In addition, SPRINT will include a central Coordinating Center (CC) that 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. 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. Each CCN will be responsible for timely recruitment and clinical care quality assurance activities in accordance with the SPRINT protocol. Each CCN will develop an appropriate subcontract arrangement with each clinical site; it is anticipated that the trial will use a per capitation reimbursement model for all or nearly all of the clinical sites in the study. In addition, the CCN will provide the networks' scientific leadership and operational management. The clinical sites within the CCN will collect data at the local level in accordance with the study protocol and the manual of operations (MOP), and will coordinate each participant's hypertension treatment. Each CCN will be responsible for recruiting a minimum of between 1,250 to 1,875 patients, including meeting study-wide goals for recruitment of women and specific minorities (African Americans, Hispanic, Native American, Asian), and for study-wide goals with regard to patients with cardiovascular disease and stage 3 CKD. The CCN will have the primary responsibility for timely evaluation and correction of recruitment problems, including development and implementation of alternative strategies to achieve the stipulated goals, and funding the related activities. It is anticipated that each CCN will conduct at least yearly site visits within its network of clinical sites to supervise recruitment activities and assure high quality performance. The CCN activities will be coordinated with the CC, and may include site visits conducted by the CC, along with other organizational components of the study, leading to certification of new sites, cessation of recruitment at existing sites, and appropriate follow-up of patients enrolled from sites whose recruitment is stopped. Each CCN will closely collaborate with and assist the CC in implementation and standardization of the protocol within their network. 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 Clinical Center Network will: 1. propose and present to the Steering Committee a step treatment drug regimen for the blood pressure strategy and for background therapy (pharmacologic and non-pharmacologic); collaborate with other CCNs, the Coordinating Center (CC), other central units (DDC, core laboratories), and the Project Office in finalizing the protocol and the manual of procedures (MOP), which includes detailed intervention and measurement descriptions and staff training procedures; 2. have or develop a communication system within the CCN, including Internet capability; this system should include means of assisting the CC in facilitating data gathering links between the CCN and central units; 3. have or obtain IRB clearance/assurances for all participating sites within the network, including an approved informed consent document; 4. assist the CC in training and monitoring staff within the CCN in uniform protocol implementation, and in following the MOP for standardization of protocol-directed procedures and data collection; clinical centers within the CCN will send appropriate measurements (e.g., blood samples, ECGs) to the CC and applicable core laboratories (e.g., Central Laboratory, ECG Reading Center) in a timely fashion, as specified in the protocol and MOP; collaborate with the CC in correcting problems with missed, delayed, and erroneous data at the respective clinical sites within the CCN; 5. recruit, randomize, manage, and follow up a minimum of 1,250 to 1,875 patients according to the study protocol and MOP; address recruitment shortfalls in a timely fashion; participate with the CC and other CCNs in classifying clinical events in study patients; 6. collect and maintain appropriate data files, and maintain appropriate confidentiality and security of these files at the respective clinical sites; 7. provide timely data on recruitment and measurements to the CC; recruitment data should include numbers of participants screened and numbers randomized, and should be categorized by gender and race; 8. arrange and lead meetings for CCN clinical site personnel; participate in study-wide meetings and committees, providing information and experts as needed; 9. assist the CC in capturing major adverse drug effects in a timely fashion to maximize patient safety, and promptly report serious adverse drug events and unanticipated problems from the appropriate clinical site, through the CCN leadership, to the Project Office and the CC, according to the protocol and the MOP; 10. ascertain and respond to clinical alerts in data measured or interpreted within the CCN, and respond to clinical alerts reported by the CC or core laboratories; 11. participate in preparing publications in collaboration with other study investigators, the CC, and the NHLBI Project Office; 12. provide a concise final report which will serve as a technical reference document, describing all of the phase activities; and 13. assist the clinical sites in collecting event outcome data (e.g. hospitalizations records). The CCN will assist the CC, the study leadership, and the DSMB in their complex 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, CCN staff will need to be highly experienced, with strong medical and scientific qualifications and credibility, and have experience relating to hypertension and internal medicine, or clinical cardiology or nephrology. CCN 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 at least 30-45 clinical sites, and extensive specialty care of patients with hypertension. The medical monitor for the CCN 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 CCN must develop highly productive working relationships with the CC, clinical sites, core laboratories, academic researchers, NHLBI Project Office, and advisory groups (e.g., PRC, DSMB). 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. 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 organization=s 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
- SN01425892-W 20071003/071001223135 (fbodaily.com)
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