In addressing the responsibilities of the Data Coordinating Center (DCC) described in the RFA HL-05-006, Sickle Cell Disease Clinical Research Network. NERI offers the following highly relevant expertise and experience. (1) The proposed PI, Co-Pi, Network Manager and Protocol Manager each have more than 10 years of experience in coordinating multi-site clinical trials and epidemiological studies, in sickle cell disease, thalassemia and other areas. (2) The DCC team includes physicians with extensive clinical and research experience in sickle cell disease, physicians with whom the DCC Team has worked for more than 10 years. (3) The DCC includes a strong team of statisticians who have designed, monitored and analyzed numerous clinical trials and epidemiological studies in sickle cell disease and other areas. (4) NERI has developed a proprietary, Oracle-based data management system - ADEPT - that has been used successfully in numerous multi-center trials, including international trials and that supports web-based data entry. (5) NERI has also developed a computerized randomization system that supports many randomization schemes (simple, permuted blocks, stratified randomization, etc.) and which is fully coordinated with the data management system. (6) NERI is experienced at establishing and running per-patient reimbursement systems, including support of multiple schedules for reimbursement. (7) NERI and the DCC team are experienced at identifying and coordinating central laboratories, endpoint adjudication panels and other central reading panels (e.g. MRI and MRA). (8) The DCC team includes expertise in measuring quality of life and cost effectiveness, experience in the statistical aspects of identifying genetic risk factors for disease, experience in research on children and experience in designing and executing equivalence and noninferiority trials. The NERI team also proposes to incorporate the following features, based on prior experience in clinical trials networks. (1) A registry of patients at the 15 Clinical Centers is proposed to assess the characteristics of the patients and the adequacy of the numbers available for each trial, to provide an immediate training vehicle for data acquisition and management before initiating a complex trial protocol, and to provide an ongoing patient resource database. (2) A web-based data acquisition and protocol management system will be implemented in ADEPT that will provide automated on-line reports, in real time, to the CCs and Program Office at NHLBI, and that will fully support per-patient payments to the sites with automated reports for triggering the payments. NERI has assembled a highly and appropriately experienced team for the DCC and offers the data management system and other resources needed to successfully coordinate the multiple parallel trials and other studies that will be undertaken by the Sickle Cell Disease Clinical Research Network.
