The Topics in Clinical Trials course is designed to follow and augment the Introduction to Clinical Trials course. The class consists of three modules: Procedural, Design, and Interpretation of Results. The goal is to provide an overview of practical aspects of conducting clinical trials and to delve deeper into design and analysis concepts introduced in the introductory course.

The first module will review key regulatory, ethical and procedural requirements for conduct of clinical trials, including a review of Good Clinical Practice Procedures, IRB and OHRP requirements and HIPAA regulations, IND requirements and principles for data acquisition, management, and distribution in the clinical research environment. The second module will discuss different designs for clinical trials including translational and dose finding/ranging trials, safety and efficacy trials, and comparative efficacy and effectiveness trials. Outcome selection and evaluation of predictive and diagnostic tools will also be discussed. The third module will focus on data monitoring and interpretation of clinical trial results. Topics will include methods for addressing missing data, discussions of the role, responsibilities and operations of Data Monitoring Boards, as well as statistical approaches to interim data monitoring, and Bayesian approaches to the design and analysis of clinical trials. The course will end with a discussion of the key features of systematic reviews, and how they can be used for synthesis of the evidence for clinical trials. The format of the course will be lecture complemented by discussion.

By the end of the course, the student will be able to do the following:

• Understand practical aspects of conducting clinical trials
• Describe the designs used for phase 1-3 clinical trials
• Understand the role of predictive and diagnostic tools in clinical trials
• Understand the purpose of interim data monitoring and describe procedures used for interim monitoring
• Be familiar with the Bayesian approaches to clinical trial design and analysis
• Know about systematic reviews for clinical trials and their role in evaluating medical evidence
• Recognize tensions that arise in evaluating drug effectiveness in a regulatory environment

This course covers the following topics:

• Good Clinical Practice Guidelines
• Ethical and Regulatory Issues
• IND and safety monitoring regulations for clinical trials
• Monitoring performance in clinical trials
• Data management fundamentals
• Designs for Phase 1 and 2 trials
• Superiority, equivalence, and non-inferiority designs for Phase 3 trials
• Selection of outcomes and patient-centered outcomes
• Prediction and diagnostic tools
• Approaches to handling missing data in analysis of clinical trial
• Structure and Function of Data Monitoring Boards
• Bayesian approaches to design and analysis of clinical trials
• Synthesis of evidence – systematic reviews
• Tensions that arise in evaluating treatment in a regulatory environment

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 sixteen lectures over the eight-week period of the fourth term.

Lectures: Students are expected to listen to the lectures as scheduled.

Evaluation: There will be two-part group project that will require students to work together on designing and planning for implementation of a phase 3 clinical trial.

Participation: Participation will be based upon your lecture attendance and participation in BBS discussions.

Grades will be based on the two-part group project and participation.

• Each assignment will be worth 40% of the grade.
• Participation: 20%. Based on your attendance and participation in discussion sessions, BBS discussions and lecture attendance. 

TextChat with Lea Drye (to be decided).

• Course readings are available online via Welch Library eReserves.
• Resource – Clinical Trials: a methodological perspective, 2nd edition (available via eReserves).  
• Links to lecture handouts, Web and e-Reserves materials, assignments, and a course bibliography may be found on this Web site. 

Please send all queries for faculty regarding course registration to TopicsCT@jhsph.edu   Course Faculty   Kay Dickersin, PhD, MA Email: TopicsCT@jhsph.edu     Steve Goodman, MD, PhD, MS Email: TopicsCT@jhsph.edu   Janet Holbrook, PhD, MPH  Email: TopicsCT@jhsph.edu   Curtis Meinert, PhD Email: TopicsCT@jhsph.edu   Milo Puhan, MD, PhD  Email: TopicsCT@jhsph.edu   Roberta W. Scherer, PhD Email: TopicsCT@jhsph.edu   Dave Shade, JD Email: TopicsCT@jhsph.edu   Elizabeth A.Sugar, PhD Email: TopicsCT@jhsph.edu   Aynur Unalp-Arida, MD, PhD  Email: TopicsCT@jhsph.edu   Lea T. Drye, PhD Email: TopicsCT@jhsph.edu