Guidelines needed for clinical trial management – not just reporting

As demonstrated by the response to the publication of the updated CONSORT statement earlier this year, the need for standardized approaches to the conduct and reporting of
randomized controlled trials is widely accepted by the clinical research community.This week in Trials, Barbara Farrell and colleagues argue the case for adopting a similar approach to clinical trial management.

Managing clinical trials
Barbara Farrell, Sara Kenyon, Haleema Shakur
Trials 2010, 11:78 (13 July 2010)

research has identified effective management as an essential element in
the successful completion of clinical trials, not least in terms of
meeting recruitment targets. In spite of evidence to suggest that poor
trial management can result in failure – wasting valuable time and
resources – there is an apparent lack of published reference material
for trial managers.

Farrell and colleagues are keen to see this
rectified through a collaborative effort from investigators, trial
managers and funders to produce standardized, enforceable guidelines
for the management of clinical trials. Moreover, it may be time for
greater recognition of trial managers for their role in generating the
evidence on which clinicians and policy makers rely.

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