SOURCES SOUGHT
A -- NINDS Clinical Research Collaboration (CRC) Facility to Execute NINDS-Sponsored Clinical Trials
- Notice Date
- 2/3/2003
- Notice Type
- Sources Sought
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Neurological Disorders and Stroke, 6001 Executive Boulevard, Neuroscience Center, Suite 3287, MSC 9531, Bethesda, MD, 20892-9531
- ZIP Code
- 20892-9531
- Solicitation Number
- NS-03-006
- Response Due
- 3/3/2003
- Point of Contact
- Desiree Wheeler, Contract Specialist, Phone 301 496-1813, Fax 301 402-4225, - Desiree Wheeler, Contract Specialist, Phone 301 496-1813, Fax 301 402-4225,
- E-Mail Address
-
dw76q@nih.gov, dw76q@nih.gov
- Description
- The National Institute of Neurological Disorders and Stroke (NINDS) is considering issuing a contract for development of a Clinical Research Collaboration (CRC) Facility to assist with the efficient execution of clinical trials and other types of NINDS-sponsored clinical research. NINDS is seeking input about the technical expertise required and available to create and operate an efficient CRC Facility, as well as input into its specific structure and design. Background Recent progress in neuroscience has led to an explosion in neurological treatments that require testing in randomized clinical trials to determine their efficacy and safety. Conventional approaches to recruitment and follow-up of participants employed in recent NINDS-sponsored trials are slow and inefficient: a recruitment/follow-up infrastructure is developed de novo for individual trials, typically involving a limited number of academically-based neurologists, with recruitment lasting several years. The overall objective of the NINDS CRC Facility is to facilitate the efficient execution of NINDS-sponsored clinical research in order to test more treatments, more expeditiously. Within the CRC Facility, hundreds of academic-based and practice-based neurologists will recruit and follow patients through access to multiple clinical trial protocols. The CRC Facility will assist investigators holding NINDS grants with the execution of clinical research and with involving the broadest possible range of patients and physicians. The CRC Facility will be a web-based network, distinctly different from traditional disease-specific investigator research networks. The CRC Facility will serve as the switchboard to coordinate clinical research projects developed and funded by independent NINDS-supported investigators. There will be multiple pathways to CRC Facility access, several levels of physician participation, the flexibility to adapt to the needs of specific research studies, and ongoing continuing medical education (CME) as a prominent component. The major aims of the CRC Facility are: 1. to expedite recruitment (achieving goals in months rather than years). 2. to involve a wide spectrum of investigators, especially practicing physicians. 3. to recruit a broad range of participants, particularly minorities. 4. to minimize the cost of the infrastructure, so that overall cost/participant are not increased. 5. to make participation in NINDS clinical research more accessible to patients. 6. to facilitate the transfer of research results to clinical practice, especially to community settings. 7. to encourage large, streamlined trial designs, particularly relevant for studies of primary prevention of neurological diseases. 8. to maintain quality by peer-review of competitive investigator-initiated studies. 9. to make study of ?small neurological diseases? economically feasible. 10. to engender a tradition of participation in clinical research and of evidence-based therapeutics among neurologists. These aims must be achieved while maintaining the highest ethical standards in human subject research, setting a benchmark for the entire neurology research community. Further details about our ideas regarding the proposed CRC Facility are found in Appendix I, derived from input received at the NINDS Clinical Research Collaboration Workshop: Exploring the Options (October 7-8, 2002). Appendix I can be obtained via email request to Desiree Wheeler, Contract Specialist, NINDS at dw76q@nih.gov. Proposals for alternative structures to achieve the aims above are solicited as part of this RFI. Information Requested Information in the areas listed below will aid in the design of a solicitation to establish and operate a CRC Facility. We request that interested organizations identify their technical expertise and resources, and capabilities and describe their availability to conduct such an endeavor. 1. Design and structure of the CRC Facility i. What are the major essential components of the CRC Facility? What expertise, capabilities, and levels of effort are required? ii. How can continuing medical education (CME) be effectively integrated into the CRC Facility for training and investigator motivation? What technical, medical, and other professional expertise is required to implement the CME? iii. What steps (or phases) are necessary for initiation of the CRC Facility? What is the proposed timeline? iv. Given a perceived need for more information about motivation/barriers to CRC Facility participation by practicing neurologists, academic neurologists and patients with neurological diseases, if and how should focus group data be used to this end, and what resources would be required? v. What scientific and technical resources are required to initiate a website to efficiently link eligible patients and physicians to NINDS-sponsored clinical research projects, including assess eligibility on-line? vi. How can access to children, women and minority participants be assured? vii. What would be the critical mass necessary to use, operate and maintain such a facility? 2. Subcontract Award and Management CRC Facility research may involve hundreds of investigators funded through awards issued by the contractor as subcontracts. Describe the personnel and database requirements associated with awarding and managing multiple subcontracts, including quality control procedures and research support services. 3. Program Management and Evaluation Initiating the CRC Facility will be a complex and multifaceted process. The contractor will additionally be required to evaluate the progress of the subcontracted research and of the efficiency of the CRC Facility. i. Describe your experience with strategic planning and initiation of comparably complex projects. ii. Describe the technical, medical, and clinical methodological expertise that you possess that is necessary for the design, operation and maintenance for the CRC Facility. iii. Describe how you would evaluate the overall performance of the CRC Facility at each stage of its development. iv. Describe your experience with meeting planning. 4. Personnel Provide an assessment of the number and mix of personnel required to create and operate the CRC Facility and the approximate level of effort required, broken down by its major components. This Request for Information is for planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government. The Government does not intend to award a contract on the basis of the responses nor otherwise pay for the preparation of any information submitted or the Government?s use of such information. Respondents will not be notified of the Government?s evaluation of the information received. Should a proposed solicitation materialize, no basis for claims against the Government shall arise as a result of a response to this request for information or the Government?s use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Responses will be held in a confidential manner. Any proprietary information should be so indicated. All respondents are asked to indicate the type and size of your business or organization, i.e. Large Business, Small Business, Hubzone Small Business, Small Disadvantaged Business, Women-Owned Business, 8(a), Historically Black College or University/Minority Institution, Veteran-Owned Small Business, Service-Disabled Veteran-Owned Small Business, educational institution, or other profit or non-profit organization. Responses should be identified with RFI No. NS-03-006 and are due by March 3, 2003. Please submit three (3) copies of your response to: Desiree Wheeler Contract Specialist Contracts Management Branch National Institute of Neurological Disorders and Stroke National Institutes of Health 6001 Executive Boulevard, Room 3282 Besthesda, MD 20892-9531 (for express mail/courier, use: Rockville, MD 20852) Email responses will also be accepted at: dw76q@nih.gov NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (03-FEB-2003). IT ACTUALLY FIRST APPEARED ON THE FEDBIZOPPS SYSTEM ON 02-JUL-2003. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/NIH/NINDS/NS-03-006/listing.html)
- Record
- SN00363336-F 20030704/030702222225 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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