Assessing New Products in Diabetes: A Business Model in Support of Clinical Decision-Making

Since 1990, more than 10 new drugs have been released for the treatment of diabetes, and there are currently 113 clinical trials on new treatment approaches listed with the Food and Drug Administration (FDA).1 It is possible that the total number of new pharmaceutical products released between 1995 and 2005 will exceed the number of all pharmaceutical products released in the United States before then.Trends in diabetes care suggest that drug treatments will often be used in combination.2 Therefore, new products will be judged not only for their effectiveness when used alone, but also for their utility in combination with other therapies.This makes the clinical decision-making process increasingly complex. It offers opportunities for better clinical results through more treatment options. However, it also expands the possibility of clinical error in treatment design or of sub-optimal treatment design from an economic and social standpoint. This brief review is intended to address the latter issues.Social and economic issues may be important considerations in the process of selecting diabetes agents and designing diabetes treatment regimens. Such issues relate to factors that may influence patients’ compliance with their treatment regimen. These include drug costs, dosing frequency, patient perceptions of the treatment, and difficulty of the treatment regimen.Typically, these sorts of considerations are not included in clinical discussions of new therapies. For example, the latest Clinical Practice …