Author
Listed:
- Roberta W. Scherer
(Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology)
- Barbara S. Hawkins
(The Johns Hopkins University, Johns Hopkins School of Medicine and Bloomberg School of Public Health)
Abstract
Successful conduct of multicenter trials requires many different types of activities, implemented by different types of centers. Resource centers are those involved in planning the trial protocol, overseeing trial conduct, and analyzing and interpreting trial data. They include clinical and data coordinating centers, reading centers, central laboratories, and others. Clinical centers prepare for the trial at their setting and accrue, treat, and follow up study participants. Each center has specific responsibilities, which are tied to the trial phase and wax and wan over the course of the trial. Activities during the planning phase are mostly the purview of the clinical and data coordinating centers, which are responsible for obtaining funding and designing a trial that will answer the specific research question being asked. The initial design phase and the protocol development and implementation phase see both resource centers and clinical centers making preparations for the trial to be conducted. The main responsibilities of clinical centers during the participant recruitment, treatment, and follow-up phases are to recruit, randomize, treat, and follow study participants and collect and transmit study data to the data coordinating center. The resource centers manage drug or device distribution, receive and manage data, and monitor trial progress. Clinical centers complete closeout visits during the participant closeout phase, while resource centers complete final data management activities, data analysis, and interpretation. The termination phase finds investigators from all centers involved in manuscript writing activities. Collaboration among all centers during all phases is essential for the successful completion of any multicenter trial.
Suggested Citation
Roberta W. Scherer & Barbara S. Hawkins, 2022.
"Centers Participating in Multicenter Trials,"
Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 7, pages 97-121,
Springer.
Handle:
RePEc:spr:sprchp:978-3-319-52636-2_30
DOI: 10.1007/978-3-319-52636-2_30
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