'It (the Clinical Study Team) Was Missing Data. And It Was Not Happy. So It Set off in Search of Its Missing Data.'

• Activity Number: 384
• Type: Topic Contributed
• Date/Time: Tuesday, July 31, 2012 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Jesse Cedarbaum*+
• Companies: Cytokinetics, Inc.

Abstract

In clinical practice, the effectiveness of a therapeutic intervention is assessed while the patient is under treatment. It is only in rare instances that the duration of effect outlives the application of the therapeutic modality itself. In contrast to the daily practice of medicine, clinical trials constitute experiments conducted under contrived conditions, with the intent of enhancing extraction of signal from information gleaned from heterogeneous populations of test subjects. Adherence to treatment, and hence "missingness" of data, may be affected by both extrinsic (to the patient/disease dyad) and intrinsic factors. Data missing due to intrinsic factors are generally considered informative, whereas data missing for extrinsic reasons are not. Extrinsic factors include co-morbidities not related to the condition under treatment, socioeconomic factors, etc. Intrinsic factors may include treatment-related adverse events and events associated with disease activity; but some of these events may, in fact be unrelated to the aspect of the disease under treatment, and hence behave as extrinsic influences on treatment adherence. In the treatment setting clinicians may filter missing