About the content
This course will provide an introduction to the scientific, statistical, and ethical aspects of clinical trials research. Topics include the design, implementation, and analysis of trials, including first-in-human studies (dose-finding, safety, proof of concept, and Phase I), Phase II, Phase III, and Phase IV studies. All aspects of the development of a study protocol will be addressed, including criteria for the selection of participants, treatments, and endpoints, randomization procedures, sample size determination, data analysis, and study interpretation. The ethical issues that arise at each phase of therapy development will be explored.
This course contains 12 modules. The modules will be released Monday of each week, with the exception of some holiday weeks. Most students should plan to spend 4 – 6 hours on each module. Students will have until February 14, 2014 to earn a HarvardX certificate.
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- The scientific, statistical, and ethical aspects of clinical trials research
- How to design, implement, and analyze data from clinical trials
- How to interpret results from clinical trials
- The ethical issues that arise at each phase of therapy development
- James Ware
- Elliott Antman
- Julie Buring
- Graham McMahon
- Marcia Testa
- Robert Truog
- Emile Yu
- Nakul Singh
- Daniela Dias-Santos
- Kathryn Field
Harvard University is a private Ivy League research university in Cambridge, Massachusetts. Established in 1636 and named for its first benefactor clergyman John Harvard, Harvard is the United States' oldest institution of higher learning, and its history, influence, and wealth have made it one of the world's most prestigious universities. The Harvard Corporation is its first chartered corporation. Although never formally affiliated with any denomination, the early College primarily trained Congregational and Unitarian clergy. Its curriculum and student body were gradually secularized during the 18th century, and by the 19th century, Harvard had emerged as the central cultural establishment among Boston elites. Following the American Civil War, President Charles W. Eliot's long tenure (1869–1909) transformed the college and affiliated professional schools into a modern research university; Harvard was a founding member of the Association of American Universities in 1900. A. Lawrence Lowell, who followed Eliot, further reformed the undergraduate curriculum and undertook aggressive expansion of Harvard's land holdings and physical plant. James Bryant Conant led the university through the Great Depression and World War II and began to reform the curriculum and liberalize admissions after the war. The undergraduate college became coeducational after its 1977 merger with Radcliffe College.
The university is organized into eleven separate academic units—ten faculties and the Radcliffe Institute for Advanced Study—with campuses throughout the Boston metropolitan area: its 209-acre (85 ha) main campus is centered on Harvard Yard in Cambridge, approximately 3 miles (5 km) northwest of Boston; the business school and athletics facilities, including Harvard Stadium, are located across the Charles River in the Allston neighborhood of Boston and the medical, dental, and public health schools are in the Longwood Medical Area. The endowment of Harvard's is worth $37.1 billion, making it the largest of any academic institution.
Harvard is a large, highly residential research university. The nominal cost of attendance is high, but the university's large endowment allows it to offer generous financial aid packages. The Harvard Library is the world's largest academic and private library system, comprising 79 individual libraries holding over 18 million items. The University is cited as one of the world's top tertiary institutions by various organizations.
Harvard's alumni include eight U.S. presidents, several foreign heads of state, 62 living billionaires, 359 Rhodes Scholars, and 242 Marshall Scholars. To date, some 157 Nobel laureates, 18 Fields Medalists, and 14 Turing Award winners have been affiliated as students, faculty, or staff. In addition, Harvard students and alumni have won 10 Academy Awards, 48 Pulitzer Prizes, and 108 Olympic medals (46 gold, 41 silver and 21 bronze).
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