CITI TRAINING GCP AND REFRESHER

Which of the following defines phase I research as it relates to non-clinical and other phases of research: - Answer-Phase I research is the first phase of research after animal testing and helps define future phase II and III studies. Approximately how many subjects generally participate in phase I studies? - Answer-20-80 As the amount of adaptive study designs and multiple-arm protocols increases, researchers are now adding small cohorts of a diseased population to phase I studies to assess the initial safety and effectiveness in the drug's targeted population. This approach allows researchers to gather preliminary efficacy data in the diseased population. An example of this would be: - Answer-A first-in-human protocol testing of a new drug being developed for the treatment of diabetes, including a group of subjects with diabetes. Many phase I studies now include adaptive study designs which allow changes to the design of the trial as new information is discovered; as is often the case with phase I studies. According to the author, adaptive trial designs have many benefits, including: - Answer-More efficient and thorough late phase multicenter research related to dose selection, subject selection, and safety monitoring. Identify the following type of study design that is generally used in first-in-human research study: - Answer-Single Ascending Dose (SAD) In first-in-human research, researchers review the non-clinical data thoroughly to assess if there is sufficient information to support the initiation of human studies. The highest dose level tested in animal species that did not produce a significant increase in adverse effects compared to a control group should be identified. This is identified as the No Observed Adverse Effect Levels (NOAEL) and is: - Answer-Much lower than the expected therapeutic level. Many phase I studies will compensate subjects for their time and participation in the research. The FDA (1998) includes the following statement in their Information Sheet on Payment to