SOLICITATION NOTICE
A -- Research and Development Sources Sought for Medical Arm of Mechanically Assisted Circulatory Support Registry (MEDAMACS)
- Notice Date
- 5/20/2009
- 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-HV-09-22
- Point of Contact
- Jeffrey A Williams, Phone: (301) 435-0338
- E-Mail Address
-
williamsja2@nhlbi.nih.gov
(williamsja2@nhlbi.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Research and Development (R&D) Sources Sought Notice. This is NOT a solicitation for proposals, proposals abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. The National Heart, Lung, and Blood Institute (NHLBI), of the National Institutes of Health, intends to negotiate on a non-competitive basis with the incumbent contractor for the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Data Coordinating Center (the University of Alabama at Birmingham) for the proposed program, Medical Arm for Mechanically Assisted Circulatory Support (MEDAMACS), a registry of advanced heart failure patients identified and followed in parallel to the patients receiving mechanical circulatory support devices collected through the existing INTERMACS program. INTERMACS is a national registry of patients receiving mechanical circulatory support device (MCSD) therapy to treat advanced heart failure. It is a collaboration among NHLBI, FDA, CMS, clinicians, scientists, and industry. To date there are 94 centers participating and over 1500 patients enrolled in the registry. MEDAMACS will provide detailed data on advanced heart failure patients managed without device utilization. Background As many as 600,000 patients in the US have advanced heart failure, and the numbers are rising. Therapeutic approaches have changed little over the last few years and include: drugs, ICDS, and pacemakers. Patients, whose heart failure progresses to later stages of the disease, have options limited to medical management, transplantation or MCSD therapy. The MEDAMACS pilot data will provide a comparator to MCSD patient data collected through INTERMACS, serve to facilitate the refinement of patient selections to enhance clinical management with current devices, and guide and expedite clinical trials for new indications and/or new devices. Ambulatory heart failure patients will be identified at selected INTERMACS sites, enrolled and followed. The program will include Data Coordinating Center support, expert collaborators, and support for up to twelve INTERMACS clinical data collection sites and their collaborating cardiologists. It is anticipated that the MEDAMACS pilot will accumulate initial data sufficient to show feasibility for a future program. Data on approximately 40-50 consecutive consenting patients, from 8-10 sites to a total of 400 advanced heart failure patients, will be collected with patients followed-up at specified time points for up to 2 years. Specific patient eligibility criteria will be defined by an expert working group. Purpose and Objectives The broad purpose of this registry pilot is to enable research to determine best medical practices for advancement of public health with respect to the use of standard and MCSD treatment of heart failure. The pilot registry utilizing the INTERMACS platform will: 1) Develop criteria for participation and identify up to twelve vanguard INTERMACS clinical data collection sites and their collaborating cardiologists; 2) Enroll prospectively a population of ambulatory heart failure patients followed on optimal medical therapy for whom chronic heart failure limits both function and survival to a range where elective implantation of left ventricular assist devices should offer meaningful benefit. It is anticipated that 40-50 consecutive consenting patients from 8-10 sites to a total of 400 advanced heart failure patients will be collected with patients followed at specified time points for up to 2 years; 3) Establish expert working groups to develop specific patient eligibility criteria, data collection parameters and data elements for heart failure patients not receiving MCSDs; 4) Utilize standard methods consistent with INTERMACS processes to collect and store patients’ clinical data including related costs; 5) Provide statistical analyses of the data; 6) Evaluate quality of life and functional capacity outcomes and facilitate the refinement of patient selection to maximize outcomes with current devices within approved indications; 7) In association with INTERMACS goals, improve economic outcomes by identifying and optimizing factors affecting cost-effectiveness; 8) Guide and expedite clinical trial planning for new indications and/or new devices including analyzing distribution of integrated functional survival endpoints to determine sample sizes for pivotal randomized trials; 9) Develop and advance a team of emerging clinical investigators in association with collaborating clinical sites who will increase awareness of mechanical circulatory support and serve as role models for other young investigators; 10) Develop a protocol, informed consent and associated Manual of Operations (MOO) documents, and obtain NHLBI approval for these documents. The MOO shall include plans for collecting patient data in compliance with patient privacy regulations, and for proper cross referencing to the source documents. The protocol shall define time collection points and data elements, among other parameters. The MOO shall include registry policies and procedures, including standard definitions, operating policies such as publications, conflict of interest, and data sharing; 11) Prepare quarterly progress reports and a final progress report and submit to the NHLBI; 12) Arrange meetings/conference calls of the INTERMACS Observational Study Monitoring Board to discuss progress of the MEDAMACS registry; 13) Prepare interim limited access data sets, a final consolidated limited access data set, and a final consolidated copy of patient data in hard copy and computerized tape formats, consistent with NHLBI policies and provide to the NHLBI; and 14) Work with participating hospitals and the clinical cardiologist collaborators to prepare abstracts and manuscripts for publication. Anticipated Period of Performance A cost reimbursement contract with an award date on or about September 30, 2009 and a period of performance for two years is anticipated. Other important considerations The data collected through MEDAMACS should be fully compatible with the web-based data collection system currently in place for the INTERMACS program. Capability Statement NHLBI is interested in soliciting capability statements from all qualified Offerors demonstrating their ability to perform this research effort. At a minimum prospective Offerors must document capabilities in the following areas which would evidence the potential to successfully complete the work of the registry: 1) Demonstrate past experience in and current capability to perform in collaborative biomedical clinical projects. Specifically, Offerors must provide a description of previous multi-center clinical research projects in which the organization and proposed personnel have participated; 2) Experience in and knowledge of cardiovascular and critical care medicine and the treatment of end-stage heart failure including the use of MCSDs as a treatment modality; 3) Experience in biostatistics, including survival analysis and computer systems include computer programmers and record analysts; 4) Experience in regulatory medicine as it applies to data collection of registries and informed consent and HIPAA requirements; 5) Experience with quality assurance and quality control, conducting site visits to assess site performance, and adherence to program procedures, timelines and program management and oversight; 6) Familiarization with INTERMACS data elements, collection, policies, and clinical sites; 7) Facilities available for receiving, processing, storing, and retrieving medical data accurately and efficiently. We ask that the capability statement not exceed 20 single sided or 10 double sided pages in length. Three (3) copies of the capability statement must be received at the following address no later than 15 calendar days from the publication date of this notice: Contracting Office Address: Jeffrey A. Williams, Contract Specialist, National Heart, Lung, and Blood Institute, NIH, DHHS Office of Acquisitions, DERA 6701 Rockledge Drive RKL2/6100 MSC 7902 Bethesda, Maryland 20892-7902 (For overnight deliveries use zip code 20817; no MSC is required.) Do not include budget information. When submitting this information, please refer to Pre-solicitation Notice NHLBI-HV-09-22. Responses that do not adhere to these guidelines will not be considered. This notice will close fifteen calendar days after posting. Questions may be directed to the Contract Specialist, Jeffrey Williams, williamsja2@nhlbi.nih.gov, 301-435-0338. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
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