The Johns Hopkins University Center for Clinical Trials (CCT) proposes to serve as the Data Coordinating Center (DCC) for a Gastroparesis Clinical Research Consortium, which will focus on the etiology, natural history, and therapies for gastroparesis. The DCC will be responsible for organization of the consortium including definition of the committee structure by specifying membership, managing the member selection process, and writing the charges for each committee, subject to consortium approval. The DCC will coordinate all aspects of communications needed by the consortium, including meetings, teleconferences, and web-based communications. The DCC will support the development of consortium policies including policies on presentations, publications, ancillary studies. The DCC will work with the NIDDK and the Steering Committee (SC) to provide the biostatistical and informations systems infrastructure to rapidly and efficiently design and conduct multicenter randomized clinical trials of potential treatments for gastroparesis. The DCC will cull information from the literature or other sources for data on standardized outcome measures needed to make sample size determinations for each proposed study. The DCC will take the initiative in the implementation, conduct, and quality control of consortium studies. The DCC will provide biostatistical analysis for data safety and monitoring reports and for presentations and publications for consortium studies. Building on systems used by ongoing research networks coordinated by the CCT, the DCC will provide a comprehensive information management system including the development and distribution of design documents (protocols, manuals, case report forms, policy memoranda, etc), a study website for up-to-date access to study-related materials, and a web-based data management system (for screening and enrollment of patients including randomization procedures for clinical trials, for data capture and display, for reporting on recruitment, and for quality control reports to improve clinical center performance). The DCC will provide other support, as needed, including the establishment of centralized laboratories, reading centers, drug distribution center, or specimen banking resources. The DCC has extensive experience with the FDA/IND process and can assist the consortium in these matters, as required. IRB and HIPAA compliance for the consortium will be monitored by the DCC

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK074008-05
Application #
7871435
Study Section
Special Emphasis Panel (ZDK1-GRB-6 (O1))
Program Officer
Hamilton, Frank A
Project Start
2006-05-01
Project End
2011-08-31
Budget Start
2010-04-01
Budget End
2011-08-31
Support Year
5
Fiscal Year
2010
Total Cost
$1,984,099
Indirect Cost
Name
Johns Hopkins University
Department
Biostatistics & Other Math Sci
Type
Schools of Public Health
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Calles-Escandón, Jorge; Koch, Kenneth L; Hasler, William L et al. (2018) Glucose sensor-augmented continuous subcutaneous insulin infusion in patients with diabetic gastroparesis: An open-label pilot prospective study. PLoS One 13:e0194759
Orthey, Perry; Yu, Daohai; Van Natta, Mark L et al. (2018) Intragastric Meal Distribution During Gastric Emptying Scintigraphy for Assessment of Fundic Accommodation: Correlation with Symptoms of Gastroparesis. J Nucl Med 59:691-697
Hasler, W L; May, K P; Wilson, L A et al. (2018) Relating gastric scintigraphy and symptoms to motility capsule transit and pressure findings in suspected gastroparesis. Neurogastroenterol Motil 30:
Pasricha, Pankaj J; Yates, Katherine P; Sarosiek, Irene et al. (2018) Aprepitant Has Mixed Effects on Nausea and Reduces Other Symptoms in Patients With Gastroparesis and Related Disorders. Gastroenterology 154:65-76.e11
Parkman, H P; Hallinan, E K; Hasler, W L et al. (2017) Early satiety and postprandial fullness in gastroparesis correlate with gastroparesis severity, gastric emptying, and water load testing. Neurogastroenterol Motil 29:
Gibbons, Simon J; Grover, Madhusudan; Choi, Kyoung Moo et al. (2017) Repeat polymorphisms in the Homo sapiens heme oxygenase-1 gene in diabetic and idiopathic gastroparesis. PLoS One 12:e0187772
Grover, M; Bernard, C E; Pasricha, P J et al. (2017) Diabetic and idiopathic gastroparesis is associated with loss of CD206-positive macrophages in the gastric antrum. Neurogastroenterol Motil 29:
Koch, K L; Hasler, W L; Yates, K P et al. (2016) Baseline features and differences in 48 week clinical outcomes in patients with gastroparesis and type 1 vs type 2 diabetes. Neurogastroenterol Motil 28:1001-15
Parkman, H P; Hallinan, E K; Hasler, W L et al. (2016) Nausea and vomiting in gastroparesis: similarities and differences in idiopathic and diabetic gastroparesis. Neurogastroenterol Motil 28:1902-1914
Farrugia, Gianrico (2015) Histologic changes in diabetic gastroparesis. Gastroenterol Clin North Am 44:31-8

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