An online decision tree for vaccine efficacy trial design during infectious disease epidemics: The InterVax-Tool.

Background: Licensed vaccines are urgently needed for emerging infectious diseases, but the nature of these epidemics causes challenges for the design of phase III trials to evaluate vaccine efficacy. Designing and executing rigorous, fast, and ethical, vaccine efficacy trials is difficult, and the decisions and limitations in the design of these trials encompass epidemiological, logistical, regulatory, statistical, and ethical dimensions.

Results: Trial design decisions are complex and interrelated, but current guidance documents do not lend themselves to efficient decision-making.

A defense attorney's perspective on medical negligence litigation.

Being named as a defendant in a lawsuit is an unnerving development. Proceeding through the discovery stage of a case can be a daunting prospect. Sitting through a trial, in which one's professional conduct is judged by six or twelve laypersons with little or no medical knowledge, often is gut wrenching.