SOURCES SOUGHT
A -- The Type 1 Diabetes TrialNet
- Notice Date
- 5/16/2007
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences (NAICS 2002)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Nat'l Institute of Diabetes, Digestive, & Kidney Diseases, 2 Democracy Plaza, Suite 700W 6707 Democracy Blvd., MSC 5455, Bethesda, MD, 20892-5455, UNITED STATES
- ZIP Code
- 20892-5455
- Solicitation Number
- NIH-NIDDK-07-03
- Response Due
- 5/31/2007
- Point of Contact
- Dana Harris, Contract Specialist, Phone 301-594-9987, Fax 301-480-4226, - Edward Kostolansky, Contract Specialist, Phone 301-594-4758, Fax 301-480-4226
- E-Mail Address
-
harrisd@extra.niddk.nih.gov, ekostola@niddk.nih.gov
- Description
- The National Institutes of Health, National Institutes of Diabetes and Digestive and Kidney Diseases is conducting a market survey to help determine the availability and technical capability of qualified small businesses, veteran-owned small businesses, service-disabled veteran-owned small businesses and/or HUBZone small businesses capable of serving the needs mentioned below. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) is seeking an organization or an institution to serve as the Coordinating Center (TNCC) for ??Type 1 Diabetes TrialNet?? (TrialNet) that will be responsible for communication and coordination among the Clinical Centers and for management of the collection and analysis of genetic, immunologic, pathogenetic, clinical and biological data from the clinical sites. The TNCC will also be responsible for: (1) support of study protocols and Manuals of Operation for each TrialNet trial, (2) maintaining the TrialNet website, and (3) organizing TrialNet Steering Committee meetings, DSMB (DSMB) meetings, EAB meetings and workshops. In addition, the TNCC will be responsible for transferring all data and biosamples that are the property of NIDDK to the appropriate NIDDK repositories. This acquisition will be solicited with minimum and maximum requirement. Award of this acquisition will be contingent on the availability of funds. All offerors will be required to submit a minimum and maximum proposal for fulfilling the requirements. TrialNet, an international consortium of clinical research groups with expertise in type 1 diabetes (T1D) research, was created to carry out randomized, controlled, multi-center clinical trials aimed at evaluating therapies for T1D prevention and early intervention. Principal researchers in the consortium include both a clinical diabetologist and a leading immunologist from each major Clinical Center. The TrialNet study group consists of a Biostatistics (Data and Operations) Coordinating Center, a Chairman??s Office, 6 Core Laboratories, a Compounding Pharmacy, 14 North American Clinical Centers, 15 North American Major Affiliate Centers, 84 North American Affiliate Centers, 4 International Clinical Centers, and 16 International Affiliate Centers. In addition, TrialNet mechanistic studies are being performed in collaboration with the Immune Tolerance Network (ITN). The primary goal of TrialNet is to conduct studies designed to evaluate new approaches to prevent or ameliorate T1D specifically by interdicting the T1D disease process. These include interventions designed to decrease ?]-cell destruction and/or enhance ?]-cell survival. TrialNet researchers hope that preservation of remaining ?]-cells will delay or prevent the onset of disease in at-risk individuals and will make disease control easier in individuals with new onset T1D. Optimal diabetes control is important because studies have clearly demonstrated that tight control results in fewer long-term complications (such as blindness, kidney failure, neuropathy, and cardiovascular disease). Other TrialNet goals include (1) further characterization of diabetes risk through genetic, autoantibody, and metabolic studies in subjects identified through the Natural History, and (2) intervention studies to further develop new therapeutics through a better understanding of the immunologic bases of diabetes by analysis of serum, RNA, DNA, and cell function in at-risk and new-onset subjects as well as controls. TrialNet has completed one clinical research study (MMTT versus GST), is in the midst of six active studies (Natural History, MMF/DZB, Anti-CD20, T Cell, NIP, and Oral Insulin) and will launch four more by the end of 2007 (Anti-CD3+Exenatide, Metabolic Control, Thymoglobulin [with ITN as lead], and IL2+Rapamycin [with ITN as lead]). Other trials have been approved but a decision to launch has not been made due to uncertainty about available funds. TrialNet also works closely with the Type 1 Diabetes Genetics Consortium, regularly supplying them with blood samples for their studies aimed at a better understanding of the genetic basis of T1D. The completed study (MMTT versus GST), comparing the Mixed Meal Tolerance Test (MMTT) to the Glucagon Stimulation Test (GST), was aimed at supporting the establishment of C-peptide as a reliable surrogate outcome measure for diabetes trials. The study was designed to determine the best method for assessing insulin production during T1D clinical trials. 138 subjects, each within 3 years of diagnosis of T1D, underwent 2 MMTTs and 2 GSTs in random order within a 6 week period. Results showed that peak C-peptide levels were significantly higher during the MMTT, indicating that detection of a C-peptide response would be more likely with the MMTT compared to the GST. Correlation data revealed that both tests were highly reproducible, but the MMTT was significantly more reproducible than the GST. One of the ongoing TrialNet studies is the Natural History Study. Relatives of type 1 diabetics are recruited into the Natural History study based on HLA genotype and on the presence of certain diabetes-associated autoantibodies in the blood. Subjects with one or more different type of diabetes autoantibody enter a program of risk assessment including glucose tolerance testing. Once subjects are identified as being at risk for the development of diabetes, they are evaluated every 6 months to assess their autoantibody and metabolic status. Close monitoring provides the benefit of rapid disease identification and avoidance of severe diabetes-onset related symptoms (such as ketoacidosis), and in addition, TrialNet has recently launched a pilot prevention trial for a group of at-risk subjects identified through the Natural History study. Current plans call for screening of 20,000 individuals per year through 2011. In the event that funding is not available, the Natural History study will be terminated early and the pilot will not progress to the full trial. Two of the TrialNet clinical research studies currently in progress involve immunumodulatory therapy in individuals with new-onset T1D. The first of these studies, involving treatment with Mycophenolate Mofetil and Daclizumab (MMF/DZB), completed enrollment of the 120 planned subjects in November 2006. This study includes follow-up of subjects through 2010. The second active new-onset study employing immunomodulatory therapy involves Anti-CD20 (Rituximab). To date, this study has enrolled 16 of the total 66 patients planned, and plans to follow subjects through 2009-2010. Another TrialNet protocol underway is the T Cell Validation Study. This mechanistic study was designed to validate four different T cell assays for reproducibility, sensitivity and specificity in detecting autoimmune responses in diabetics versus controls. T cell measurements are expected to provide important information relating to interventions in TrialNet??s clinical trials. This study is expected to complete recruitment in the North American sites by the end of February 2007, and 3 months later in the United Kingdom. It will involve approximately 200 subjects at all sites combined. Another round of assay testing is expected to launch prior to the end of the first quarter 2007, and to be completed by mid 2008. TrialNet has recently launched the Nutritional Intervention to Prevent Type 1 Diabetes Pilot Trial (NIP). In this trial, 90 newborn infants possessing a first degree relative with T1D and no diabetes-protective HLA alleles will be randomized to receive supplemental omega-3-polyunsaturated fatty acid (DHA) through either maternal (breast milk) or formula supplementation. The trial is a pilot aiming to accrue all 90 subjects within one year and then follow them over 2 years. DHA will be measured in blood to determine whether the target value of 20% higher DHA is achieved in the treated compared to control group. In addition, a 20% lower level of an inflammatory cytokine, IL1-beta, in the treated population is a primary objective of the pilot trial. The pilot trial is expected to be completed by the end of 2009. The Oral Insulin Trial pilot was launched in January 2007. This trial will test a hypothesis suggested by post hoc analysis of the earlier NIDDK-sponsored Diabetes Prevention Trial-Type 1 (DPT-1). That trial suggested that individuals with high levels of insulin autoantibodies in their blood, as well as other characteristics resulting in a 25-50% chance of getting T1D over the subsequent 5 years, could delay or prevent the onset of diabetes by taking insulin by mouth. TrialNet will confirm or refute the hypothesis by recruiting subjects with similar characteristics into a trial involving daily insulin or placebo ingestion over approximately 5-8 years. The trial is expected to recruit approximately 300 subjects through 2011 and follow them through 2018. In the event that funding is not available, the trial will halt recruiting and subjects will be followed as funding permits, if scientifically warranted. Two additional TrialNet-led intervention trials are approved and under development, Anti-CD3+Exenatide and Metabolic Control. The Anti-CD3+Exenatide trial will be a randomized controlled open label trial. Recently-diagnosed type 1 diabetics will be treated with a GLP-1 agonist, Exenatide, which is expected to promote insulin responsiveness and to help maintain residual ??-cell activity, and Anti-CD3 which has been previously determined to delay the decline in C-peptide production in newly-diagnosed T1D patients. After safety review of the combination of drugs in 30 patients, the plan is to extend the treatment to 130 additional subjects. In addition, a 4-arm trial is being planned for subjects with impaired glucose tolerance, not yet clinically diabetic, but with an 80% risk of developing frank diabetes over the subsequent 5 years. For new onset trials the primary endpoints are C-peptide production at 1 or 2 years, while the prevention trial will use diabetes onset as the primary endpoint. The new-onset trial is expected to be completed in 2010, while the prevention trial is expected to be finished in 2012. In the event that funding is not available, the prevention trial will not be initiated. The newly approved Metabolic Control trial aims to provide very intensive metabolic control to subjects within a few days of T1D onset. The plan is to use a system of continuous glucose monitoring and closed-loop insulin delivery in the hospital, followed by intense monitoring and insulin pump at home. The patients will be randomized to either very intense or standard-of-care treatment and followed for C peptide production at 1 and 2 years post diagnosis, and should be completed in 2010. The contract is for a ten-year period, unless funding is not available, in which case the contract will be for a 4 to 5 year period. As can be readily appreciated by the above descriptions, the TrialNet consortium has embarked upon a series of complex and challenging studies and trials, aimed at taking full advantage of the current opportunities for diabetes intervention, and to offer reasonable therapeutic options to recently diagnosed and at risk populations. In each case, statistical methods and trial design have emphasized maximizing efficiency and minimizing trial duration by, for example, using maximum information design whenever possible. In addition, by investing in infrastructure for recruiting, TrialNet expects to maximize efficiency and to capture all patient populations for which trial opportunities exist. Finally, by investing in studies to optimize diabetes risk assessment, and to optimize clinical tests and validate mechanistic assays, TrialNet hopes to produce accurate and reliable information to allow optimization of the information to be extracted from each clinical trial and subject. These activities are expected to provide the basis for treatments that can significantly delay or stop the decline of ??-cell function in subjects at risk for or recently diagnosed with T1D. Current plans are to continue to launch a limited number of approved new trials though 2008. Additional approved new trials will be launched only if sufficient funds are available. Thereafter, if funding resources do not continue, TrialNet and the TNCC will adjust operations for completion of active trials launched by 2008, but will cease the initiation of new trials or the transition from pilot trials to full trials. If funding continues, TrialNet will continue to solicit, review, develop, and execute new trials, and the TNCC operation will be maintained to accommodate those needs. It is expected that new trials will replace old ones and the TrialNet consortium will operate as projected herein. Project Overview: Work to be performed under this contract may include design, development and launch of approved studies as well as execution of protocols including screening, recruitment, intervention, and follow-up according to schedules and procedures contained in the studies?? Manuals of Operations. The TNCC shall receive, manage, and analyze data obtained from the Clinical Centers. Clinical Centers and Core Laboratories will be responsible for reporting data on standardized study forms supplied by the TNCC. Data forms will be forwarded directly from the clinics to the TNCC, which shall edit and enter data into the master database. All data shall be stored, maintained, and analyzed at the TNCC. In addition, the TNCC shall prepare reports of the results of these assessments for transmittal in a standardized format. The TNCC shall have a key role in the operational conduct of TrialNet and in data analysis in accordance with policies set forth by TrialNet for each study protocol. The Project Officer will provide technical direction in the execution of these responsibilities. For each TrialNet study protocol, the TNCC shall: (1) provide overall coordination of all data collection and analysis, (2) provide technical assistance in performance of the follow-up assessments, (3) manage protocol implementation, and (4) work in conjunction with the Clinical Centers and Core Laboratories to oversee all aspects of performance, including timeliness of data submission and quality of performance. These activities shall include the procurement and administration of subcontracts for laboratory services. In addition, the TNCC will be responsible for the timely distribution of payments for services rendered to the laboratory and other subcontractors, as well as capitated reimbursements to the Clinical Centers for clinical procedures performed during the course of TrialNet. The Contractor shall also provide administrative support services for the TrialNet Study Group, DSMB, and EAB. The TNCC shall perform surveillance of data collection to assure adequate adherence to the protocol, shall process and analyze all data from the study, and shall prepare interim technical and statistical reports for review by the DSMB, the EAB and other internal committees such as the Steering Committee. These reports shall be due at least 15 days before scheduled meetings. Periodic meetings to evaluate data and performance shall be held as indicated in 2.a.7) Periodic Meetings below. A comprehensive series of written and tabular technical and statistical reports of the results of the overall Phase 1 study shall be prepared by the Contractor for review by the Study Group, the DSMB, the EAB and the Project Officer. These reports shall be due at least 15 days in advance of scheduled meetings. Preparation of these reports will be a collaborative effort involving the Clinical Centers, the TNCC, and the NIDDK. However, the TNCC shall be the focal point for this activity including and not limited to preparation and distribution of drafts and final copy. Additionally, the TNCC shall provide biostatistical and operational expertise and advice to the clinical centers and the NIDDK in the consideration of revisions to the protocols, Manuals of Operation and study forms and in development of procedures to implement these revisions. Below is an overview of the subcontracts to the TNCC: TrialNet Coordinating Center Subcontracts Clinical Centers ?V There are 17 TrialNet Clinical Centers located in North America, Europe, and Australia. These Centers receive infrastructure support as well as per-patient capitated reimbursements. All of the Clinical Centers enroll patients into multiple TrialNet clinical research studies and will thus need to continue to follow their TrialNet study patients until all protocols have been completed. Protocol duration varies from 2 to 8 years. Clinical Center Subcontractors ?V Several of the Clinical Centers have subcontractors working with them on TrialNet projects. They are subcontractors because they are located at sites that are distinct from (but generally close to) the parent Clinical Center. The subcontractors that enroll patients into TrialNet clinical research studies will need to continue to follow their TrialNet study patients until all protocols have been completed. Protocol duration varies from 2 to 8 years. Major Affiliate Centers ?V There are 17 TrialNet Major Affiliate Centers located in North America. These Centers receive infrastructure support as well as per-patient capitated reimbursements. All of the Major Affiliates enroll patients into one or more TrialNet clinical research studies and will thus need to continue to follow their TrialNet study patients until the pertinent TrialNet protocols have been completed. Protocol duration varies from 2 to 8 years. Affiliate Centers ?V There are currently 178 TrialNet Affiliate Centers located in North America. These Centers receive per-patient capitated reimbursements. Almost all of the Affiliate Centers enroll patients into one or more TrialNet clinical research studies and will thus need to continue to follow their TrialNet study patients until the pertinent TrialNet protocols have been completed. Protocol duration varies from 2 to 8 years. Core Laboratories ?V There are 5 TrialNet Core Laboratories located in North America. These Core Laboratories receive infrastructure support to perform as central laboratories for all of the TrialNet studies. It is crucial that the TrialNet Core Laboratories remain unchanged so that the intra- and inter-study laboratory data remains optimally comparable and reliable. The Core Laboratories will need to continue to analyze TrialNet samples generated by TrialNet clinical research studies until the TrialNet protocols have been completed. Protocol duration varies from 2 to 8 years. Laboratories ?V There are 7 TrialNet Laboratories located in North America and Europe. These laboratories perform studies specific to one or more TrialNet studies. These laboratories will need to remain constant until the studies they are involved with are completed to ensure optimization of intra- and inter-study data. Medical Monitor ?V The TrialNet Medical Monitor oversees the adverse event process related to all TrialNet studies. This includes planning for tracking and evaluating adverse events, processing adverse event reports, and reporting adverse events to the appropriate parties, including the DSMB, IRBs, and appropriate regulatory agencies. Central Pharmacy and Supplies ?V The TrialNet Central Pharmacy handles all aspects of receipt, processing, and distribution of TrialNet study drug supplies. For some studies, this includes production of drug and placebo. This group also handles distribution of various medical supplies to the TrialNet sites. Consultants ?V TrialNet utilizes consultants to assist with various TrialNet functions. These consultants advise TrialNet on psychosocial and infectious disease issues related to the conduct of TrialNet trials. A detailed listing of the 230+ clinical centers, affiliate centers, laboratories, central pharmacy, medical monitor, and consultants will be provided upon the release of the Request for Proposal. Special Instructions: If you or your firm has an interest and possess the required expertise we invite you to submit a corporate capability statement to assist the Government in determining in accordance with Federal Acquisition Regulation (FAR) 19.502-2(b) whether or not this procurement will be set-aside for any of the programs described above. The intended procurement will be classified under North American Industrial Classification (NAICS) code 541710 with a size standard of 500 employees. All respondents are requested to identify their firm's size and type of business. Interested firms responding to this sources sought should adhere to the following: (a) Provide a capability statement demonstrating relevant experience, skills and ability to fulfill the Government's requirements for the above. The capability statement should contain sufficient detail for the Government to make an informed decision regarding your capabilities. The capability statement should not exceed 25 pages and five (5) copies should be submitted. (b) The capability statement should include references, key personnel, and any teaming arrangements needed to fulfill the requirements. (c) All capability statements must be submitted in writing to the address identified in this synopsis no later than May 31, 2007 no later than 3:00pm eastern standard time. Responses will not be accepted via email or fax. This notice is for information and planning purposes only and is not to be construed as a commitment by the Government, nor will the Government pay for information solicited. NOTE: THIS NOTICE MAY HAVE POSTED ON FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (16-MAY-2007). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 13-NOV-2007, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.fbo.gov/spg/HHS/NIH/NIDDKD/NIH-NIDDK-07-03/listing.html)
- Place of Performance
- Address: Bethesda, MD
- Zip Code: 20817
- Country: UNITED STATES
- Zip Code: 20817
- Record
- SN01451464-F 20071115/071113224340 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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