London School of Hygiene & Tropical Medicine

There is unprecedented interest in estimating the safety and effectiveness of medicines. The widespread and near-real-time availability of real-world data (RWD) offers opportunities to quickly generate real-world evidence (RWE) to address these needs. Observational studies are vulnerable to many potential biases and translating RWD into high-quality RWE requires careful consideration of the scientific process including identification of fit-for-purpose data and selection of the most appropriate design, measurement, and analysis methods to mitigate potential biases.

The aim of this course is to equip students with the understanding and techniques to generate RWE on safety and effectiveness of medicines and overcome common sources of error, with practical applications using electronic health record data.

During this online course, students will: 

• Develop their knowledge of concepts, study designs, and methods in pharmacoepidemiology
• Apply statistical techniques to generate real-world evidence using electronic health record data from the Clinical Practice Research Datalink in Stata (prior experience of Stata not required)
• Understand biases and other sources of error that can occur in studies using real-world data, and identify and apply strategies to avoid them

Who should apply?

Individuals concerned with the safe and effective use of medicines should apply, especially those working in:

• The pharmaceutical industry who are involved in drug development, licensing, or surveillance
• Regulatory bodies who are involved in licensing & surveillance
• Academics interested in evaluating drug safety and effectiveness
• The health service who are involved in drug policy and decision making

The course is designed for individuals with a grounding in epidemiological methods and concepts and/or some prior knowledge of pharmacoepidemiology, especially those who have completed the Certificate in Pharmacoepidemiology & Pharmacovigilance.

Applicants will normally have a science, biomedical or biostatistical background, hold a second class honours degree of a United Kingdom university (or equivalent) in a science, medical, statistical or related subject and will have some post-graduate experience in the area of pharamacoepidemiology, including an understanding of methodological concepts such as bias and confounding. It is not expected that applicants will actually be conducting pharmacoepidemiology studies. Applicants should have a good command of English.

Up to 30 participants will be accepted.

Advice for EU nationals

Students from the EU are very welcome at LSHTM and we would strongly encourage applications from EU nationals to this course.

• Beyond Brexit: Why is Europe so important to us