Information Mediary Corporation, Canada
Allan Wilson is full professor of psychiatry at the University of Ottawa and co-founder and president of Information Mediary Corporation, the Ottawa-based manufacturer of the Med-ic and eCap electronic compliance monitors. He has over 25 years experience in clinical research and has published over 100 academic papers in the fields of psychiatry and addiction medicine.
It has been known since classical times that patients are poorly compliant with their physicians recommendations. In the last few decades a large body of literature has shown that poor patient compliance with prescribed medication affects adversely virtually all areas of clinical medicine. Recently, accurate means of capturing compliance data electronically have become available. Among clinical researchers it is widely accepted that having information about patient noncompliance would be a good thing. Unfortunately, there are no clear guidelines as to how to utilize such data once they have been obtained. This talk is designed to provide guidelines for the use of electronically obtained compliance data at two levels in clinical research. The first describes conceptually how to apply noncompliance data to the primary outcome measures of efficacy in randomized, repeated measures, and adaptive trial designs. The second addresses the use of post hoc analyses of compliance data to optimize their value to the pharmaceutical industry. Specifically, techniques are described by which noncompliance events can be viewed in a unique way that maintains the time factor in their analyses. Examples of return on investment using electronic compliance monitoring are demonstrated.