This course introduces you to how Real World Data/Evidence can be used for pharmaceutical research and development and how it complements the evidence package for healthcare decision-making. If you are interested in applying data science to pharmaceutical research using data collected as part of routine clinical practice, this course is for you.


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Explain how real world data/evidence fits into the drug development process
Describe the three major types of bias that can be encountered in observational studies
Apply basic survival analysis techniques such as Kaplan-Meier plots and Cox Models to synthetic data.
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In this module we briefly introduce the phases in drug development and the evidence generation process to bring treatments to patients. We then exemplify how real-world data/evidence fits into the drug development.
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In this module, we explore the limitations of real-world data. We discuss several sources of real-world data and explain their strengths and weaknesses. We then create clearer definitions of the types of bias that can be encountered when exploring real-world data.
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In this module we explore study designs for observational data and methods to control for bias (systematic errors). We also mention concrete examples used in pharmaceutical research.
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In this module we will design and conduct our own study using synthetic data to explore the concepts learned in modules 1-3.
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In this module we consider the point of view of two critical stakeholders: regulators and payers. We see their position about real world data/evidence and its acceptance. We also explore specific use cases of how real world evidence has been used in practice.
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To access the course materials, assignments and to earn a Certificate, you will need to purchase the Certificate experience when you enroll in a course. You can try a Free Trial instead, or apply for Financial Aid. The course may offer 'Full Course, No Certificate' instead. This option lets you see all course materials, submit required assessments, and get a final grade. This also means that you will not be able to purchase a Certificate experience.
When you enroll in the course, you get access to all of the courses in the Specialization, and you earn a certificate when you complete the work. Your electronic Certificate will be added to your Accomplishments page - from there, you can print your Certificate or add it to your LinkedIn profile.
Yes. In select learning programs, you can apply for financial aid or a scholarship if you canāt afford the enrollment fee. If fin aid or scholarship is available for your learning program selection, youāll find a link to apply on the description page.
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