Changes in the characteristics of new drug applications for the treatment and prevention of diabetes mellitus

Efforts in managing diabetes, including the medical advances in novel therapies and public health policies of disease control and prevention, have not reduced the disease prevalence since 1990s. I analyze this phenomenon from the technology and policy viewpoints underlying diabetes treatment and prevention, in order to control and manage the disease in a cost-benefit balanced manner. The innovative performance of the antidiabetic drug therapy is investigated by analyzing the fifteen New Drug Applications (NDAs) of the antidiabetics approved by the US Food and Drug Administration since the early 1990s. I examine the characteristics of the clinical trials supporting NDAs and observe how the complexity of clinical trials has changed over time. Nine out of the twenty-five selected indicators are found to exhibit an increasing trend of complexity. The trend is more pronounced in the oral antiglycemics group (seven indicators) than the subcutaneous group (two indicators). Interestingly, this trend in increasing complexity in clinical trials is generally consistent with that of the increasing R&D costs in the pharmaceutical industry, possibly account for the declining innovative performance of the industry over the time period under investigation. A system dynamics approach is applied to assess current public health policies in diabetes control and prevention.

Department dc:contributor.department

Massachusetts Institute of Technology. Department of Civil and Environmental Engineering

Grantor dc:publisher

Massachusetts Institute of Technology

Year dc:date.issued

2007

Author dc:creator

• Lin, Hsiao-Lan Sharon

Advisor dc:contributor.advisor

• Ernst R. Berndt and Fred Moavenzadeh.

• Civil and Environmental Engineering.
• Technology and Policy Program.

Statement dc:rights

• M.I.T. theses are protected by copyright. They may be viewed from this source for any purpose, but reproduction or distribution in any format is prohibited without written permission. See provided URL for inquiries about permission.

Licence dc:rights.uri

• http://dspace.mit.edu/handle/1721.1/7582

Language dc:language.iso

eng

Handle dc:identifier.uri

http://hdl.handle.net/1721.1/38580

OAI identifier oai:identifier

oai:dspace.mit.edu:1721.1/38580