Complete the post-test online at www.cmeuniversity.com. On the navigation menu, click on "Find Post-tests by Course" and search by project ID 4962. Upon registering and successfully completing the post-test with a score of 70% or better and the evaluation, your certificate will be made available immediately. At this time, you will also have the opportunity to download a pdf of the post-test answer rationales.
Quiz
A pharmaceutical company has contacted you to ask if you would be interested in participating in a clinical trial of their investigational oral acne medication. You will be expected to enroll at least 10 patients on an outpatient basis, and your practice will be 1 of 20 sites in the United States only. In previous trials, the investigational agent has been shown to be safe at doses up to 10 mg/d, and this trial randomizes patients to doses of 1 mg/d, 3 mg/d, and 5 mg/d or placebo. What is the most likely phase of this study?
a) Phase 1
b) Phase 2
c) Phase 3
d) Phase 4
You have been asked to participate in a Phase 3 study by Division Pharmaceuticals. You have been reading up on the different study phases to educate yourself about what your involvement will entail. Which of the following have you found to be a general characteristic of a Phase 3 trial?
a) Tests many dose regimens of the investigational agent against placebo in a limited number of patients
b) Often uses an ascending-dose study design
c) Is a randomized controlled study that enrolls large numbers of patients across the country and often in multiple countries
d) Compares one marketed compound to another marketed compound
You have been approached about enrolling patients in a Phase 3 study but not all of the Phase 2 studies have been completed yet. Should you be concerned based on this fact alone?
a) Yes
b) No
You are excited to enroll patients in a clinical trial that will examine the use of a glucosamine/chondroitin supplement on osteoporosis risk in women undergoing menopause. What type of trial is this?
a) Treatment trial
b) Prevention trial
c) Diagnostic trial
d) Screening trial
A colleague has approached you about recruiting patients for a clinical trial that examines the use of a new handheld, ultraviolet light-based tool for diagnosing precancerous skin lesions. What type of patient population would this trial need?
a) Healthy persons without any risk factors of disease
b) Healthy persons with risk factors of disease
c) Persons who are known to have the disease
d) None of the above