FDA Public Meeting Report on "Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implications".

Potential drug interactions with hormonal contraceptives are an important public health concern. A public meeting on "Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implication" was hosted by the United States Food and Drug Administration (FDA). The meeting endeavored to provide an opportunity for the FDA to seek input from experts on the public health concerns associated with the use of hormonal contraceptives and interacting drugs that might affect efficacy and safety, including pharmacokinetic/pharmacodynamic considerations, in the design of drug interaction studies of hormonal contraceptives for drug development and approaches to translating the results of drug interaction information into informative labeling and communication. The input received could be used to refine FDA's thinking on hormonal contraceptives drug interaction study design and interpretation and labeling communication of drug interaction risk. This meeting benefited from strong and diverse participation from the Center for Drug Evaluation and Research at the FDA, Centers for Disease Control and Prevention, National Institutes of Health, Swedish Medical Products Agency, pharmaceutical industry, and representatives of academia. This report provides a summary of the key discussion based on the presentations and panel discussion.

Informed consent procedures: an experimental test using a virtual character in a dialog systems training application.

Researchers are generally trained to administer informed consent by studying approved guidelines, but still can fail to satisfactorily answer questions from potential participants. An application using a virtual character allowed novice participants to practice administering informed consent. This character was designed to behave as a potential participant for a study and asked many of the questions research participants typically ask, such as queries about the study itself, the sponsor, timing, selection procedures, confidentiality, voluntariness, benefits and risks, and contact information. The user responded to the character's queries as if speaking with a true potential research participant. The application was effective even after only brief usage. In a laboratory experiment, novice participants who practiced with the virtual character were later more effective in conducting informed consent interviews with a human interviewee than those who were trained only with written materials. Thus, simulated learning-by-doing improved informed consent skills. Implications for related health dialog applications are discussed.