Health Policy
Using law to improve population health and the quality of health care services
Funding Body: Australian Research Council (Federation Fellowship)
Chief Investigator: David Studdert
Description: This research program will combine methods from the social and statistical sciences with traditional legal analysis to explore a set of pressing policy issues at the intersection of legal and health systems in Australia, including: medical negligence litigation and consumer complaints; innovative approaches to compensation and dispute resolution in accident compensation schemes; the role and impact of coronial investigations in injury prevention; and the clash of law and science in litigation over severe birth injuries.
Compliance with adverse event reporting requirements in cancer clinical trials
Funding Body: National Institute of Health
Chief Investigators: David Studdert and Steven Joffe (Dana-Faber Cancer Institute)
Description: Methods for estimating the incidence of adverse events (AEs) in clinical trials have not been developed.This study adapts chart review-based methods developed for identifying AEs in the routine clinical (non-research) setting to the clinical trial context. The specific aims of the proposal include: 1) to estimate the incidence of reportable AEs in phase II cancer trials; 2) to estimate the proportion of AEs that meet reporting criteria but are not reported, as required; and 3) to estimate the interrater reliability of reviewers' judgments concerning critical elements of AE determination, including severity, attribution to study interventions, and expectedness.
Designing a reliable system of medical justice.
Funding Bodies: The Robert Wood Johnson Foundation, Commonwealth Fund, Harvard Program on Health System Improvement
Chief Investigators: David Studdert & Michelle Mello (Harvard)
Description: The goal of this study is to provide research to support demonstration projects of an administrative compensation system for medical injury, called "health courts". The project is investigating issues such as compensation criteria, costs, appropriate damages, constitutionality, and relationship of the system to patient safety.