Changes in the characteristics of approved New Drug Applications for antihypertensives

In this thesis, the control of hypertension provides the backdrop for my effort to investigate how clinical trial design has evolved for antihypertensive drug submissions reviewed and approved by the Food and Drug Administration between 1988 and 2001. To do this, I have constructed and undertaken a preliminary analysis of a number of quantitative surrogate measures of complexity and scale, such as trial design, numbers of patients, treatment lengths, active drug comparators, number of indications pursued, number of indications approved, and approval times. In addition, I review how practice guidelines for the treatment of hypertension have changed with advancing clinical and biological knowledge. I attempt to investigate whether a link exists between the changing characteristics of clinical trials for antihypertensive therapies and the evolving guidelines for treating hypertension, promulgated by the Joint National Committee Report on the Detection, Evaluation, and Treatment of High Blood Pressure, (JNC), a committee assembled by the National Heart, Lung, and Blood Institute.

Department dc:contributor.department

Massachusetts Institute of Technology. Technology and Policy Program.

Grantor dc:publisher

Massachusetts Institute of Technology

Year dc:date.issued

2007

Author dc:creator

• MacNeil, John Simon Howe

Advisor dc:contributor.advisor

• Ernst R. Berndt.

• 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/1721.1/40373

OAI identifier oai:identifier

oai:dspace.mit.edu:1721.1/40373