title: Clinical trials in the face of adversity.
abstract: Technological advances in genetic and biomedical research have led to a startling number of adverse events in clinical trials. Reporting systems for adverse and serious adverse events should be aimed at reducing the future risks through analysis of the conditions leading to the adverse events. Unfortunately, current reporting systems are not adequate for performing this function. Many medical organizations, most notably the Institute of Medicine (part of the National Academy of Sciences), have written suggestions on how to renovate the current reporting systems. It is the author's view that these suggestions and the responses from other organizations fall short of developing a fully useful system of adverse event reporting. Instead, a system that the public, the regulatory bodies, and the researchers can easily understand and utilize for developing safer, more responsible, clinical trials is proposed.
authors.affiliation: Bioinformatics Program, Boston University, USA.
authors.forename: Karl
authors.initials: K
authors.lastname: Clodfelter
mesh_terms: D002986:Clinical Trials as Topic / Q000009:adverse effects* / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D006801:Humans; D019221:Mandatory Reporting; D015969:National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division; D009316:National Institutes of Health (U.S.); D014481:United States; D014486:United States Food and Drug Administration