The National Myelodysplastic Syndromes (MDS) Natural History Study- Data Coordinating Center
Added: Feb 28, 2013 11:47 am
The NHLBI is seeking a Data Coordinating Center (DCC) for a new program, The National Myelodysplastic Syndromes (MDS) Natural History Study (The National MDS Study). The purpose of this announcement is to provide a Presolicitation Notice for the release of Solicitation NHLBI-ECB-HB-2014-05-AC. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION.Background and Program ObjectivesThe National Heart, Lung, and Blood Institute (NHLBI) is seeking to better understand the progression of myelodysplastic syndromes (MDS) through the initiation of an observational study of adults newly diagnosed with MDS, titled The National Myelodysplastic Syndromes Natural History Study (The National MDS Study).An estimated 20,000 or more new cases of MDS are diagnosed in the United States each year. The incidence of MDS dramatically increases with age. MDS is a heterogeneous collection of clonal blood disorders characterized by ineffective hematopoiesis leading to anemia, neutropenia, and thrombocytopenia. While most cases occur in older adults, chemotherapy and other toxin-induced MDS and MDS due to inherited disorders occur in younger persons as well. Those suffering with this syndrome are predisposed to lethal infections, iron overload from repeated transfusions, and life-threatening bleeding. Some patients with MDS can develop chemotherapy-resistant acute myeloid leukemia. Most therapies for MDS are suboptimal and not curative. MDS is frequently asymptomatic, but clinically suspected in older patients with abnormal routine blood tests, recurrent infections, or excessive bleeding. Diagnosis requires evaluation of bone marrow for evidence of cells that are maturing abnormally and malignant cells. These findings, combined with peripheral cytopenia(s), abnormal bone marrow cytogenetics, and the degree of transfusion dependence, have been used to classify patients with MDS into risk groups and provide a general assessment of disease severity and possible prognosis. However, biomarkers that are clinically useful for accurate diagnosis, prognosis, and prediction of a patient's response to therapy are not available.The etiologies of MDS are not well defined. Distinct mutations and genetic modifications are thought to underlie the molecular basis of MDS, some of which may be independent predictors of poor survival. A comprehensive standardized longitudinal clinical dataset and a consistently-processed, well-annotated biospecimen collection will provide national resources that potentially can be used to: (1) identify genetic, epigenetic and biological factors associated with initiation and progression of MDS; (2) uncover fundamental information on the changes that occur in hematopoietic stem cells and bone marrow stroma during normal aging; (3) reveal clinically useful biomarkers; (4) identify potential targets for new interventions; and (5) facilitate understanding of how patients with MDS are managed in practice. These resources will facilitate the conduct of basic and translational research on the evolution of MDS over time, and improve the diagnosis and clinical management of affected individuals. Project RequirementsThis requirement is for a Data Coordinating Center (DCC) to provide overall coordination for The National MDS Study, which proposes to establish a cohort of 2,000 adults recently diagnosed with MDS, and up to 500 age-matched participants who are not diagnosed with MDS, but who are clinically suspected of having this syndrome. Most participants will be enrolled in The National MDS Study by clinical sites participating in either the National Cancer Institute's (NCI) Clinical Trials Network (NCTN) or NCI's Community Clinical Oncology Program (CCOP) Network. The DCC is expected to be experienced and highly competent in designing, coordinating, implementing, monitoring, and analyzing large (>500 participants) multi-center clinical studies, and shall provide all necessary administrative, data management, and statistical support for The National MDS Study. Throughout the contract, the DCC will serve on the Protocol Writing Team, the Steering Committee, and the Executive Committee. The DCC will work collaboratively with these committees, the Central Laboratory and Biorepository, multiple organizations that participate in NCI-sponsored clinical trials, including the NCTN and the CCOPs, and NHLBI and NCI staff to accomplish the goals of the study. The DCC shall have demonstrated knowledge and leadership in biostatistics and epidemiological studies, and experience in developing, managing and implementing procedures and protocols for multi-center clinical studies that collect hematological biospecimens for future research. The DCC shall coordinate communications and logistics for The National MDS Study. The DCC shall be responsible for helping to develop and finalize The National MDS Study protocol. It is anticipated that molecular and genomic research studies involving selected patients with MDS will be conducted to enhance the value of the biospecimen and data resource, such as low-risk risk patients whose disease progresses while on study. The DCC will assist with the review and prioritization of these additional studies and will distribute funds for approved research studies.The DCC shall be responsible for training clinical center staff in the study procedures, analyzing complex datasets, reporting data to an Observational Study Monitoring Board (OSMB), and preparing data for presentations and publication. The DCC will provide the facilities, informatics programs, validated operating procedures, and quality assurance programs necessary to coordinate The National MDS Study. This will include proficiency in multiple data systems; experience in customizing existing data systems; electronically acquiring and transferring data to and from multiple data systems in a secure and safe manner, including the data systems used by NCTN, a central laboratory or a biorepository; experience in linking and merging data sets from multiple sources; and experience in performing efficient informative searches of a biospecimen inventory for selecting samples for research studies. At the end of the contract, the DCC will transfer the biospecimen collection and all associated electronic documents and data files to a new facility at NHLBI's request.The DCC is expected to provide the necessary technical expertise and facilities to effectively perform the tasks and meet the requirements identified below:1. Experienced and highly competent in designing, coordinating, implementing, monitoring, analyzing, and reporting large (>500 participants) multi-center clinical studies that involve collecting biospecimens. Demonstrated experience in providing the necessary scientific experts, regulatory oversight, statistical and administrative support for these multi-center studies. 2. Key personnel with demonstrated knowledge and leadership in biostatistics, clinical research, and epidemiological studies; demonstrated ability and success in collaborating with multiple organizations to accomplish the same study; and demonstrated experience in research using biospecimens from clinical studies, as attested by his or her publication record.3. Key personnel with demonstrated experience in developing, managing, and implementing procedures and protocols for multi-center clinical studies; experience with procedures to facilitate real-time central review of data or laboratory findings; and demonstrated leadership for a multi-center clinical study associated with a central laboratory. 4. Provide an expert in performing clinical research in MDS.5. Provide expert advisors and consultants needed to support The National MDS Study, including a centralized review for histopathology.6. Provide demonstrated abilities to analyze large, complex datasets; report data to an Observational Study Monitoring Board or Data Safety Monitoring Board; and prepare data for presentations and publication. 7. Demonstrated proficiency in multiple data systems. Experience in customizing existing data systems. Experience in electronically acquiring and transferring data to and from multiple data systems in a secure and safe manner, including the data systems used by NCTN, a central laboratory or a biorepository; experience in linking and merging data sets from multiple sources; and experience in performing efficient informative searches of a biospecimen inventory for selecting samples for research studies.8. Demonstrated proficiency in developing and maintaining robust and secure private and public websites for multi-center clinical studies that meet Federal requirements.9. Transfer interim, final, and redacted datasets together with all associated electronic documentation in a secure and safe manner in accordance with NIH and NHLBI policies. Other Important ConsiderationsUnder this solicitation, the Government anticipates award of one (1) Indefinite Delivery, Indefinite Quantity (IDIQ) contract with cost-reimbursement task orders for a period of approximately seven to eight years with an estimated award date of July 1, 2014.This is not a Request for Proposal (RFP) and the Government is not committed to award a contract pursuant to this announcement. It is anticipated that the RFP will be available on FedBizOpps (http://www.fedbizopps.gov) on or about March 15, 2013. Offerors are responsible for monitoring the FedBizOpps Web page for the release of the solicitation and any amendments. This advertisement does not commit the Government to award a contract.
NHLBI-ECB-HB-2014-05-AC Department of Health and Human Services National Institutes of Health
2/28/13, 11:47 AM