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Establishing a
Structure for Planning & Communication
If nothing else, a
multicenter clinical trial is a collaborative effort. Generally,
a planning committee is created early for the purpose of furthering
the collaboration by organizing each of the components and phases
of the RCT protocol--see Table
1.1 for an outline of RCT components. Sub-committees can be
created for planning, identifying potential centers, investigators,
physical resources, and even funding possibilities. Early in the
planning stages attention should also be directed to developing
plans and criteria for data management, data analysis, and report
writing.
The need for clear
and consistent channels of communication is absolutely essential.
Multicenter trials will inevitably require multiple meetings over
time at many levels. Participation and enduring cooperation can
be facilitated by involvement of as many people as possible in
the planning process and when defining responsibilities for conducting
different levels of the trial.
Each center contemplated
for inclusion in the development of a multicenter RCT should have,
from the beginning, a clear understanding of that center's role
and level of involvement. Not all centers are equally "research-rich"
and it is inevitable that one or two centers take lead roles in
planning and managing a multicenter trial--a kind of "first
among equals". However, such levels of responsibility, clear
chains of command, making clear who the PI and key personnel will
be and extent of involvement for all key personnel and lead centers
should be laid out clearly and early in the planning process and
then communicated to all potential investigating centers for their
evaluation.
Timetables for reporting
and timetables for receiving feedback should be built into all
levels of the communication process.
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