Baby Hug Follow-Up Study II - Clinical Sites

The National Heart, Lung, and Blood Institute (NHLBI), NIH intends to negotiate on a non-competitive basis with the following ten (10) organizations for the Baby Hug Follow-Up Study II: Children's Research Institute, Duke Medical Center, Howard University, Johns Hopkins University, Medical University of South Carolina, St. Jude Children's Hospital, State University of New York, University of Miami, University of Mississippi, and University of Texas Southwestern. The cited authorities are 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1 and HHSAR 306-302-1. The proposed period of performance is five years with a 9-month option period for data analysis.

The 10 organizations identified above were awarded contracts in 2000 on a competitive basis to perform as Clinical Sites for the project entitled "Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG)". In 2008, all of the contracts were modified to add Follow-Up Study I on a noncompetitive basis which is still currently being performed. The incumbent contractors are uniquely qualified to perform Follow-Up Study II because they possess unparalleled experience, personnel, and systems to conduct the Follow-Up Study II. The above clinical sites have identified, recruited, and retained a unique cohort of study subjects that are essential to the performance and successful completion of the Follow-Up Study II. In addition, inherent duplication of costs to the Government and unacceptable delays in completing the project make competition unfeasible for this requirement.

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.

Capability statements submitted in response to this notice that do not provide sufficient information for review will not be considered. 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 October 8, 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.