ASTHMA NETWORK DATA COORDINATING CENTER

Project: Research project

Project Details

Description

Asthma, a disease defined as reversible airway obstruction, afflicts both genders, all age groups, and all racial/minority groups. The NHLBI is establishing an Asthma Clinical Research Network (ACRN) and this is a cooperative agreement application for Penn State University to serve as the Data Coordinating Center (DCC) for the ACRN. The role of the DCC in this endeavor is characterized by administrative support, biostatistical leadership, and data management support for the ACRN. Administrative support for the ACRN includes facilitating an atmosphere of scientific collaboration and cooperation between all participating individuals and institutions; establishing and promoting an effective communication, data transfer, and reporting structure among the DCC, the Clinical Centers, and the NHLBI; organizing meetings of the Steering Committee and sub- committees; overseeing the sub-contract with the laboratory performing the chemical analysis of blood samples; and coordinating the development and distribution of the study protocols and Manual of Operations. Biostatistical leadership for the ACRN includes comparing the merits of potential experimental designs; proposing optimal experimental designs; selecting homogeneous study groups and implementing methods to remove systematic bias; projecting appropriate sample sizes to achieve the stated clinical objectives; selecting a method of randomization; ensuring that pharmaceutical formulations or other types of treatment are masked in a sufficient manner; monitoring quality control of chemical assays; providing the Steering Committee and External Advisory Committee with interim and final data summaries and biostatistical analyses; and collaborating on the presentations at professional meetings and the submission of manuscripts for publication. Data management support for the ACRN includes developing a distributed data system for data entry at the Clinical Centers and transmission to the DCC; providing a system for subject enrollment, randomization, and data collection; designing the data collection forms; developing a system for tracking subjects, compliance, data, and blood specimens; executing procedures for data security and data quality control, storage, and back-up; and reporting accrual, adverse events, and subject safety.
StatusFinished
Effective start/end date9/30/938/31/99

Funding

  • National Heart, Lung, and Blood Institute
  • National Heart, Lung, and Blood Institute
  • National Heart, Lung, and Blood Institute
  • National Heart, Lung, and Blood Institute
  • National Heart, Lung, and Blood Institute
  • National Heart, Lung, and Blood Institute
  • National Heart, Lung, and Blood Institute
  • National Heart, Lung, and Blood Institute
  • National Heart, Lung, and Blood Institute

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