Developing appropriate and cost effective
monitoring strategies
A major focus in the trial conduct area will
be to identify optimal trial monitoring methods.
This is a broad topic from high-level trial
governance processes, such as those undertaken by an independent
data monitoring committee through to checks of the reliability of
individual patient data items. It incorporates monitoring of trial
sites with respect to compliance with Good Clinical Practice (GCP),
protocol treatments and investigations, and accuracy and timeliness
of data.
The assumption that on-site monitoring is
the optimal method for monitoring clinical trial activities has
major resource implications. If used in isolation it may also give
sponsors false reassurance of trial quality. It may be that central
monitoring methods are a more efficient way of identifying
systematic problems of the kind that can introduce bias or affect
patient safety. We consequently need evidence of the benefits and
costs of different monitoring strategies.
Key
projects
Systematic search
of literature comparing monitoring techniques
A retrospective review of
monitoring findings from an international phase III clinical
trial
Development and testing on an
optimal central monitoring strategy
Prospective evaluation and refinement of a
targeted on-site monitoring strategy
Randomised study of alternative approaches to
improve response to follow up requests in randomised controlled
trials
