Development of statistical methodologies and risk models to perform real-time safety monitoring in interventional cardiology

Post-marketing surveillance of medical pharmaceuticals and devices has received a great deal of media, legislative, and academic attention in the last decade. Among medical devices, these have largely been due to a small number of highly publicized adverse events, some of them in the domain of cardiac surgery and interventional cardiology. Phase three clinical trials for these devices are generally underpowered to detect rare adverse event rates, are performed in near-optimal environments, and regulators face significant pressure to deliver important medical devices to the public in a timely fashion. All of these factors emphasize the importance of systematic monitoring of these devices after being released to the public, and the FDA and other regulatory agencies continue to struggle to perform this duty using a variety of voluntary and mandatory adverse event rate reporting policies. Data quality and comprehensiveness have generally suffered in this environment, and delayed awareness of potential problems. However, a number of mandatory reporting policies combined with improved standardization of data collection and definitions in the field of interventional cardiology and other clinical domains have provided recent opportunities for nearly "real-time" safety monitoring of medical device data.

Department dc:contributor.department

Harvard University--MIT Division of Health Sciences and Technology.

Grantor dc:publisher

Massachusetts Institute of Technology

Year dc:date.issued

2006

Author dc:creator

• Matheny, Michael E. (Michael Edwin)

Advisor dc:contributor.advisor

• Frederic S. Resnic.

• Harvard University--MIT Division of Health Sciences and Technology.

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/1721.1/35554

OAI identifier oai:identifier

oai:dspace.mit.edu:1721.1/35554