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Updated in [March 06th, 2023]

HarvardX's Fundamentals of Clinical Trials course provides an introduction to the scientific, statistical, and ethical aspects of clinical trials research. The course is divided into 12 modules, released on a weekly basis, and students have until February 14, 2014 to earn a HarvardX certificate. Topics covered 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 also be explored.

Before the course starts, students are encouraged to explore the edX Demo to get a feel for the interactive learning environment and virtual labs. All students are expected to abide by the edX honor code and HarvardX's research statement. HarvardX and Harvard University are committed to maintaining a safe and healthy educational and work environment in which no member of the community is excluded from participation in, denied the benefits of, or subjected to discrimination or harassment in our program.

[Applications]
Upon completion of the Fundamentals of Clinical Trials course, students will have a better understanding of the scientific, statistical, and ethical aspects of clinical trials research. They will be able to design, implement, and analyze trials, including first-in-human studies, Phase II, Phase III, and Phase IV studies. Additionally, they will be able to apply the knowledge they have gained to develop study protocols, select participants, treatments, and endpoints, and determine sample size. Furthermore, they will be able to identify and address ethical issues that arise at each phase of therapy development.

[Career Paths]
1. Clinical Research Associate: Clinical Research Associates (CRAs) are responsible for the management and coordination of clinical trials. They are responsible for ensuring that the trials are conducted in accordance with the protocol, applicable regulations, and Good Clinical Practices (GCP). CRAs are also responsible for monitoring the progress of the trial, ensuring that data is collected and reported accurately, and that the safety of the participants is maintained. The demand for CRAs is expected to grow as the number of clinical trials increases.

2. Clinical Data Manager: Clinical Data Managers (CDMs) are responsible for the collection, management, and analysis of clinical trial data. They are responsible for ensuring that the data is accurate and complete, and that it is stored securely. CDMs are also responsible for developing and maintaining databases, and for providing reports to the clinical trial team. The demand for CDMs is expected to grow as the number of clinical trials increases.

3. Clinical Trial Statistician: Clinical Trial Statisticians (CTSs) are responsible for the design, analysis, and interpretation of clinical trial data. They are responsible for developing and validating statistical models, and for providing statistical support to the clinical trial team. The demand for CTSs is expected to grow as the number of clinical trials increases.

4. Clinical Trial Monitor: Clinical Trial Monitors (CTMs) are responsible for the oversight and monitoring of clinical trials. They are responsible for ensuring that the trials are conducted in accordance with the protocol, applicable regulations, and Good Clinical Practices (GCP). CTMs are also responsible for ensuring that the safety of the participants is maintained, and that the data is collected and reported accurately. The demand for CTMs is expected to grow as the number of clinical trials increases.

[Education Paths]
Recommended Degree Paths:
1. Master of Science in Clinical Research: This degree program provides students with the knowledge and skills necessary to design, conduct, and analyze clinical trials. Students will learn about the ethical considerations of clinical trials, the regulatory environment, and the principles of clinical trial design. This degree is ideal for those interested in pursuing a career in clinical research or clinical trial management.

2. Master of Science in Biostatistics: This degree program focuses on the application of statistical methods to the analysis of biological data. Students will learn about the principles of biostatistics, including data collection, analysis, and interpretation. This degree is ideal for those interested in pursuing a career in biostatistics or data science.

3. Doctor of Philosophy in Clinical Trials: This degree program provides students with the advanced knowledge and skills necessary to design, conduct, and analyze clinical trials. Students will learn about the ethical considerations of clinical trials, the regulatory environment, and the principles of clinical trial design. This degree is ideal for those interested in pursuing a career in clinical research or clinical trial management.

Developing Trends:
1. The use of technology in clinical trials is becoming increasingly popular, with the use of mobile devices, wearables, and other digital tools to collect data and monitor patient health.

2. The use of artificial intelligence and machine learning in clinical trials is becoming more common, with the use of algorithms to analyze data and make predictions.

3. The use of real-world evidence in clinical trials is becoming more common, with the use of data from electronic health records, patient registries, and other sources to inform clinical trial design and analysis.

4. The use of patient-reported outcomes in clinical trials is becoming more common, with the use of surveys and other tools to collect data directly from patients.