HMX Pro Pharmacology
Clinical Drug Development
Advance your career with a Harvard Medical School certificate.
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.
Fill out the form below to get more information on this exciting learning opportunity:
Course Information
Upcoming course periods
September 5 – November 17, 2023 | Apply now through August 15
January 9 – March 22, 2024 | Application opens August 16
April 9 – June 21, 2024 | Application opens December 6
Course length
The course period is 10 weeks long. New lessons are released periodically, and all material remains available until the course closes. Expect to spend a total of 10-20 hours for this course.
Course cost
US$995 for an individual course
Think others at your company would be interested? We offer group discounts and direct enrollment options – contact us to learn more.
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
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 drug discovery and development for their work.
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
HMX Learner Testimonials
Siyan Xu
Biostatistician, Novartis
“I’ve found all the courses to be tremendously helpful.”
Mariam Fida
Medical geneticist
“It was amazing the way all the animations were conducted, and how they show concepts in a very basic, nice way.”
Eugenia Prohin
Clinical operations manager
“Everybody involved in clinical research would benefit from these courses.”
Matthew Tagliaferro
Account executive, Ambry Genetics
“Being able to hear from the doctors and clinicians themselves about the different treatments and disease states, I think it gives such a good perspective.”