Introduces clinical trial design in the context of epidemiological concepts, covers various topics in the design and conduct of clinical trials, and profiles clinical trials that illustrate these issues. Topics include the definition and history of clinical trials; trial designs, including phase I–IV, cross-over, factorial, and large, simple designs; internal and external validity; controls, randomization, and masking; ethical issues; data analysis principles; monitoring of accumulating safety and efficacy data; and adverse event reporting.
Upon successfully completing this course, students will be able to:
Grades will be based on the assignments, the final exam, and participation.
This course covers the following topics:
This is a three-unit course taught through the Johns Hopkins Bloomberg School of Public Health Distance Education Division. The content of the course is presented through seventeen lectures, and the concepts applied through five assignments over the eight-week period of the first term.
Lectures: Students are expected to listen to the lectures as scheduled. There will be the five assignments (described below).
Assignments: After each assignment is made available on the Web site, students should review the assignment instructions and begin work. The assignment can be discussed with other students on the course bulletin board.
Final Exam: This will be a closed-book exam consisting of multiple choice, true/false and short answer questions. The exam will be taken online, and you will not need a proctor.
Participation: Participation will be based upon your attendance and participation in LiveTalks, participation with BBS discussions and completion of course lectures.
Please note the following:
The "Poison Squad "(Division of Chemistry, 1883)
Source: FDA. Retrieved November 13, 2008, from http://www.fda.gov/oc/history/historyoffda/default.htm
Please send all queries for faculty regarding course registration to firstname.lastname@example.org
Janet Holbrook, PhD, MPH
Lea Drye, PhD
Kay Dickersin, PhD
Jay Herson, PhD
Barbara Martin, PhD
Concerns about course topics and assignments
Technical concerns about the functionality and operation of course Web pages (before emailing, please make sure that you can replicate the problem)
Technical help with JHSPH email or desktop applications
Chat via Text Chat
Students enrolled in the Bloomberg School of Public Health of The Johns Hopkins University assume an obligation to conduct themselves in a manner appropriate to the University's mission as an institution of higher education. A student is obligated to refrain from acts which he or she knows, or under the circumstances has reason to know, impair the academic integrity of the University. Violations of academic integrity include, but are not limited to: cheating; plagiarism; knowingly furnishing false information to any agent of the University for inclusion in the academic record; violation of the rights and welfare of animal or human subjects in research; and misconduct as a member of either School or University committees or recognized groups or organizations.
Students should be familiar with the policies and procedures specified under Policy and Procedure Manual Student-01 (Academic Ethics), available on the school’s http://my.jhsph.edu portal.
The faculty, staff and students of the Bloomberg School of Public Health and the Johns Hopkins University have the shared responsibility to conduct themselves in a manner that upholds the law and respects the rights of others. Students enrolled in the School are subject to the Student Conduct Code (detailed in Policy and Procedure Manual Student-06) and assume an obligation to conduct themselves in a manner which upholds the law and respects the rights of others. They are responsible for maintaining the academic integrity of the institution and for preserving an environment conducive to the safe pursuit of the School's educational, research, and professional practice missions.