HMX Pro Pharmacology
Clinical Drug Development: Clinical Trial Methodologies and Innovations
Learn how therapeutics are assessed during clinical drug development.
Clinical drug development has evolved dramatically over time and the field continues to advance today. The methodology of clinical trials has evolved with new techniques being introduced, the design and statistical aspects have become more sophisticated in parallel with the increased use of technology and the introduction of new drug modalities. The rigor and discipline of this process means that people can trust that the medicines they take are likely to be safe and effective and that beneficial treatments can make their way through the process in a safe and timely manner.
Learning about the process of clinical drug development has important implications for anyone working in health care and related sectors. This advanced course offers a unique way for professionals to learn from leading Harvard Medical School faculty about how drugs are developed clinically and about the advances happening in this field that are ultimately helping to improve the treatment and prevention of disease.
This course explores the evolving field of clinical drug development. It covers several key aspects of conducting clinical trials, including epidemiological considerations, trial design strategies, statistical methods for data analysis, and oversight and review processes. This course is ideally suited for those who have completed the HMX Drug Discovery and Development course, or for professionals who want to stay up-to-date with the latest advances in clinical drug development.
Course Topics
Overview of Clinical Drug Development
- Introduction to Clinical Drug Development
- The Promise of Clinical Drug Development
Epidemiologic Considerations
- Establishing a Causal Pathway
- Chance and Bias
- Confounding and Effect Modification
- Basic Epidemiologic Considerations
- Surrogate Endpoints
- Clinical Linkage: PCSK9 Inhibitors
Clinical Trials
- Fundamentals of Randomized Trial Design
- Anatomy of a Randomized Trial
- Types of Clinical Trials
- Adaptive Platform Trials
- Data Presentation
- Data Interpretation
- Real World Data Interpretation
- Clinical Linkage: Systems Biology
Oversight and Review
- Ethical Issues in Clinical Trials
- Informed Consent and Institutional Review Board
- Data and Safety Monitoring Board
- Regulatory Review
- Process of Drug Review
- Non-neutral Comparators
- Reporting on Clinical Trial Results
Wrap-up
- The Future of Clinical Drug Development
Course Instructors
Kate McDonnell-Dowling, PhD
Lecturer in Biological Chemistry and Molecular Pharmacology, Harvard Medical School
Associate Director of Curriculum, HMX
Paul Ridker, MD, MPH
Eugene Braunwald Professor of Medicine, Harvard Medical School
Senior Physician, Brigham and Women’s Hospital
Director of the Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital
More Information
Frequently asked questions
Who should take this course?
This course is designed for professionals in health care, life sciences, and related industries who want to have a better understanding of clinical drug development for their work.
You should participate in this course if you are:
- Seeking a firm understanding of the process of clinical drug development following preclinical research.
- Working in a related sector and would like to update your knowledge of the latest advancements in clinical trial methodologies.
- A health care professional looking to advance your expertise in clinical drug development and trial design.
What do participants need to know to succeed in this course?
We recommend basic knowledge of chemistry, biology, and physics, as well as an understanding of key pharmacology concepts. If you need further background in pharmacology, we also offer an introductory course, HMX Pro Pharmacology – Essentials.
Not sure? Take this short quiz to gauge your knowledge of pharmacology concepts.
What is the time commitment?
Most people can expect to spend around 15–20 hours total, but this depends on your baseline knowledge, how carefully you take notes, and how seriously you take the assessments. New course material is released periodically, and remains available until the course period ends, so participants can work at their own pace. There is a final exam at the end of each course that can be taken any time during the final exam period.
Can participants earn certificates from Harvard Medical School?
There are two certification levels, based on participant scores:
- Certificate of Achievement
- Certificate of Completion