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Preventing and Treating Missing Data in Longitudinal Clinical Trials by Craig Mallinckrodt

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4 Trial Design Considerations

4.1 Introduction

One of the key recommendations from the NRC guidance on prevention and treatment of missing data (NRC, 2010) is that investigators, sponsors, and regulators should design clinical trials consistent with the goal of maximizing the number of participants maintained on the protocol-specified interventions until the outcome data are collected.

However, minimizing missing data is easier said than done. The usefulness of data from actual clinical trials in assessing how design features influence retention is limited because studies are not done with this objective in mind. Therefore, most assessments are on a between-study basis, and thus many confounding factors can mask or exaggerate differences attributable ...

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