ALS 461: Phase 1 Clinical Trials
Course Number: ALS 461
Course Name: Phase 1 Clinical Trials
Year: Second-year
Semester: Spring
No. Units: 0.5
Description
This course should provide students with a deeper understanding of the important role of Phase I studies in early pharmaceutical development. Students expand their knowledge of the business and scientific aspects of initiating first-time-in-human (FTIH) Phase I studies. Students will learn more about what preclinical data are needed to file with regulatory agencies, such as the US FDA, before initiating Phase I trials. They will also learn about typical Phase I trial designs, the recruitment of healthy human volunteers and situations in which it is appropriate to treat patients with your new drug in Phase I trials, rather than healthy volunteers. We will explore the Tegenero tragedy of 2006, and understand what can go wrong, and the risks that companies take when they initiate Phase I, FTIH trials.
Hopefully, this course will provide students with valuable information for employment with a pharmaceutical company, a company that provides products or services to pharmaceutical companies, or a management consulting firm. The types of positions that you might consider based on information in this course include: consulting, business development, regulatory affairs and project management.
Students are expected to already know the fundamental terminology and timelines of drug discovery, from initial idea to IND. ALS 330 is a requirement for this course - sorry, no exceptions. In addition, ALS 461 is intended to provide additional specific information about clinical trials, and is not an introductory course. Students are expected to have taken a general clinical trials course prior to, or concurrently with, ALS 461. (Students Spring 2011, please see note in Prerequisites). We will explore additional case studies from industry that exemplify best-practices in early clinical development. This is a science/technical course that will freely intersperse business and regulatory issues into the lectures and assignments.
Prerequisites
ALS 461 is intended to provide additional specific information about clinical trials, and is not an introductory course. Students are expected to have taken a general clinical trials course such as ALS 433 prior to, or concurrently with, ALS 461.
Because meeting this course requirement will be difficult or impossible for students in the Class of 2011, it is strongly recommended that students obtain the book Fundamentals of Clinical Trials, by Lawrence M. Friedman, Curt D. Furberg, David L. DeMets Springer; 4th ed. edition (2010). It is $60 from Amazon as a paperback (390pgs).
Grading
| Homework | 30% | |
| Participation | 20% | |
| Final paper | 50% |
Required Texts