RÉSUMÉ
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. We created InterVax-Tool (http://vaxeval.com), an online, interactive decision-support tool, to help diverse stakeholders navigate the decisions in the design of phase III vaccine trials. InterVax-Tool offers high-level visual and interactive assistance through a set of four decision trees, guiding users through selection of the: (1) Primary Endpoint, (2) Target Population, (3) Randomization Scheme, and, (4) Comparator. We provide guidance on how key considerations - grouped as Epidemiological, Vaccine-related, Infrastructural, or Sociocultural - inform each decision in the trial design process. CONCLUSIONS: InterVax-Tool facilitates structured, transparent, and collaborative discussion of trial design, while recording the decision-making process. Users can save and share their decisions, which is useful both for comparing proposed trial designs, and for justifying particular design choices. Here, we describe the goals and features of InterVax-Tool as well as its application to the design of a Zika vaccine efficacy trial.
Sujet(s)
Essais cliniques comme sujet , Contrôle des maladies transmissibles , Arbres de décision , Plan de recherche , Vaccins , Navigateur , Contrôle des maladies transmissibles/méthodes , Humains , Vaccins/administration et posologie , Vaccins/immunologie , Virus Zika/immunologie , Infection par le virus Zika/immunologie , Infection par le virus Zika/prévention et contrôleRÉSUMÉ
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. In this day and age, many physicians, including extremely well qualified specialists, often must deal with these realities. To cope best with these events, this article is an attempt to summarize certain legal principles that are relevant to these cases and to emphasize the practical realities that are attendant to medical negligence litigation.