SOURCES SOUGHT
A -- Baby Hug Follow-Up Study II – Clinical Site
- Notice Date
- 9/3/2010
- Notice Type
- Sources Sought
- 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
- NIH-NHLBI-RDSS-HB-12-02
- Archive Date
- 1/9/2012
- Point of Contact
- Sara Levy, Phone: 301-435-0329, Lynn M Furtaw, Phone: 301-435-0357
- E-Mail Address
-
levys2@nhlbi.nih.gov, lynn.furtaw@nih.gov
(levys2@nhlbi.nih.gov, lynn.furtaw@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Heart, Lung, and Blood Institute (NHLBI), NIH is conducting a market survey to assess the availability and technical capability of all qualified sources to perform as a Clinical Site (CS) for the BABY HUG Follow-Up Study II. It is anticipated that multiple awards for this requirement will be made by January 2012 for a period of five years, with an option for an additional 9-month data analysis period. Small businesses are encouraged to respond, including certified HUBZone, 8(a), Woman-Owned, Small Disadvantaged and/or Service Disabled Veteran-Owned or Veteran-Owned small business concerns. In 2000, the NHLBI awarded contracts to conduct a randomized, double-blind, placebo-controlled trial in young children with sickle cell disease (SCD) to test the hypothesis that Hydroxyurea (HU) can prevent the onset of chronic end organ damage in children recruited before two years of age. Contracts were awarded to ten Clinical Centers to recruit, enroll, and follow patients to monitor clinical responsiveness to study treatments, to assess growth and development, and to monitor for toxicity from study treatments. Surrogate markers of end organ damage were used to evaluate pulmonary, renal, splenic, and brain function as well as developmental milestones. One Medical Coordinating Center was awarded to oversee drug distribution, coordinate central laboratory functions, perform data collection and analysis, and conduct clinical sites visits to monitor study performance. The trial enrolled 193 subjects with SCD between the ages of 9 and 17 months from October 2003 to June 2007. Subjects remained on study drug for a period of two years. HU demonstrated substantial clinical benefit without serious toxicity in this cohort of very young children. In 2008, a follow-up study was added to the contracts to provide structured follow-up of the children after they completed their two years on study drug. The purpose of the initial Follow-Up Study is to characterize the long-term toxicities and unexpected risks (if any) associated with treatment with HU at an early age. Information obtained from this follow-up study is vitally important to understand the risks and benefits of early treatment, and ultimately for creation of an optimal paradigm for HU therapy in young children with sickle cell anemia. The Follow-Up study ends in December 2011. The purpose of the BABY HUG Follow-Up Study II is to provide continued structured follow-up of the children enrolled in the BABY HUG Follow-Up Study I, to characterize the long-term toxicities and unexpected risks (if any) associated with HU treatment at an early age, and to determine if there are clinical benefits from the treatment. Collection and ongoing evaluation of growth and development and clinical data are crucial for determination of the long-term effects of HU. The objective is to intensively monitor and assess this unique group of children for growth, development, and clinical status at least through the first decade of life to document any alterations in the natural history of sickle cell disease associated with early HU therapy. The follow-up will include enhanced neuropsychological, brain, cardiac, and pulmonary evaluations. All children enrolled will be followed to a common termination date of December 31, 2016. Results from the Follow-up Study II will improve understanding of the natural history of SCD in young children and in a cohort receiving HU. Whether or not HU reduces organ damage in these children will be established. If HU has a beneficial effect, the standard of care for children with SCD will be permanently altered. The tasks to be performed by the Clinical Sites include: (1) ensuring the timely finalization and implementation of the study protocol and timely IRB approval of the study protocol; (2) enrolling patients who have completed the “Phase III Clinical Trial - Follow-Up Observational Study I” protocol, whose parents or legal guardians consent to have their children participate in the study, including obtaining informed consent for patient enrollment; (3) following subjects at established time intervals, performing medical tests, and monitoring patients as indicated by the study protocol; (4) forwarding biological specimens collected to the Blood and Chemistry Laboratory and Cytogenetics Laboratory as described in the protocol; (5) transmitting complete and accurate subject clinical data to the Data Coordinating Center on a timely basis; (6) entering and editing case report forms as requested by the Data Coordinating Center; (7) participating in face to face and telephone meetings of study investigators and coordinators; (8) participating in routine site visits performed by the Data Coordinating Center to evaluate data quality; (9) ensuring execution and secure storage of all study regulatory and clinical documents; (10) completing periodic study reports to evaluate data quality; and (11) participating in the analysis of data and the writing of manuscripts and reports for publication, and presenting the findings of the research study at scientific meetings. Organizations having demonstrated experience in performing the above requirements are invited to submit capability statements. Capability statements must document the following: (1) ability to coordinate and manage a clinical site that is part of a multicenter observational clinical trial and direct experience in performing as a clinical site for studies of a similar nature; (2) ability to perform and experience in performing the required tasks that are described above, (3) demonstration of past success in the timely recruitment of subjects from an existing cohort for participation in follow-up observational clinical trials and retention of these patients as research subjects throughout the duration of the follow-up observational clinical trials; (4) organizational experience in the collection of data and biospecimens, performance of medical tests, as well as experience in monitoring the quality and timeliness of data; (5) qualifications of personnel with expertise in pediatric sickle cell disease, drug treatments, adverse reactions to drug therapies, expertise in interpretations of clinical laboratory results, as well as experience in data collection, monitoring, standardization, quality control, and preparation of scientific reports and manuscripts; and (6) availability and adequacy of facilities, equipment, space and any other resources necessary for the performance of the tasks identified above. Your capability statement must include your size status for the NAICS Code 541712 and whether or not you are a certified HUBZone, 8(a), Woman-Owned, Small Disadvantaged and/or Service Disabled Veteran-Owned or Veteran-Owned Small Business concern, in order to assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. Capability statements submitted in response to this notice that do not provide sufficient information for review will not be considered. Standard company brochures will not be considered a sufficient response to this sources sought synopsis. This is NOT a Request for Proposals (RFP), and responses should NOT include budgetary information. Respondents to this notice shall provide capability statements (original and three copies) no later than 3:30pm EST on September 17, 2010 to the following address: National Institutes of Health, National Heart, Lung, and Blood Institute, Office of Acquisitions, Rockledge II – Room 6102, 6701 Rockledge Drive – MSC 7902, Bethesda, MD 20892-7902 (use 20817 for express mail), Attention: Sara Levy, Contract Specialist. Capability statements may also be emailed (as a Word document or PDF): to Sara Levy at: levys2@nhlbi.nih.gov. 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. 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.
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