A clinical trial. OCRe PERSON: Melissa Haendel Research project that uses or collects measurements or assessments about humans. This should be imported from OCRE- but they currently have no generic human study type. Def is modified. human study A clinical trial to evaluate the efficacy of a new drug. An interventional study that contains a set of procedures in medical research and drug development that are conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols) that is performed over phases. PERSON: Nicole Vasilevsky http://en.wikipedia.org/wiki/Clinical_trial Phase describes the level of a trial required of drugs before (and after) they are routinely used in clinical practice: - Phase I trials assess toxic effects on humans (not many people participate in them, and usually without controls); - Phase ll trials assess therapeutic benefit (usually involving a few hundred people, usually with controls, but not always); - Phase III trials compare the new treatment against standard (or placebo) treatment (usually a full randomised controlled trial). At this point, a drug can be approved for community use. - Phase IV monitors a new treatment in the community, often to evaluate longterm safety and effectiveness. [Glossary of Terms in The Cochrane Collaboration] A trial can be of a combination phase (e.g., I/II). The concept of phase is not applicable to trials studying certain interventions (e.g., device, procedure, behavioral) Simona A Phase 0 trial is an exploratory trial involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening study, microdose study). [http://prsinfo.clinicaltrials.gov/definitions.html] Simona A Phase I trial assesses toxic effects on humans (not many people participate, and usually without controls) [Glossary of Terms in The Cochrane Collaboration] Simona A Phase ll trial assesses therapeutic benefit (usually involving a few hundred people, usually with controls, but not always) [Glossary of Terms in The Cochrane Collaboration] Simona A Phase III trial compares the new treatment against standard (or placebo) treatment (usually a full randomised controlled trial). At this point, a drug can be approved for community use. [Glossary of Terms in The Cochrane Collaboration] Simona A Phase IV study monitors a new treatment in the community, often to evaluate longterm safety and effectiveness. [Glossary of Terms in The Cochrane Collaboration] Simona A single group study is an interventional study that has only a single allocation group and no contemporaneuos comparison group. A study in which an individual acts has his/her own comparison does not fall into this category, since an individual is not a group. Simona Simona: to be reviewed A role of observing or treating patients