Learning objectives
- Describe the various costs associated with all aspects of clinical trials for both the research and general community
- Analyze the factors that influence a study budget, including how different trial designs impact cost components.
- Evaluate the challenges involved in accurately estimating a study budget and identify strategies to address them
- Identify and differentiate the various types of costs encountered in clinical trial budget estimation
Module Summary
CONTENT
Learning outcomes
CONTENT
Learning objectives
At the end of the course, the participant can:
- Explain how to conduct a clinical trial
- Explain the roles and responsibilities of the investigator and site staff, the tools and documents needed and how to track and keep records during the course of the study
- Describe the informed consent process and the management of subjects’ safety and safety reporting
- Describe the process to handle, store and document the study medication and medical devices
- Trainer/in: Samantha Chan
Module Summary
The basic Statistics course prepares learners to apply core statistical concepts in the context of clinical research. Participants will learn to apply key statistical principles, distinguish between common study designs and justify their selection based on specific research objectives, and construct research questions that are aligned to statistical principles. They will develop the ability to outline and critically review the key components of the statistic aspects of a study protocol and a statistical analysis plan. In addition, learners will assess when advanced trial designs—such as adaptive trials—are warranted and appraise their implications for study implementation and interpretation.
Learning outcomes
At the end of this course participants will be able to apply core statistical concepts relevant to clinical research, including outcome types, effect measures and underlying estimands.
Learning objectives
- Classify statistical objectives in clinical research: description, modelling, or causal inference.
- Implement the key attributes of the estimand framework
- Discuss the role of intercurrent events in planning a study and during study conduct
- Apply different handling strategies for intercurrent events
- Classify different types of statistical variables used in clinical research
- Select appropriate statistical endpoints for clinical research questions.
- Interpret common summary effect measures.
- Interpret the concepts of hypothesis testing, p-values and confidence intervals
- Implement the core components for a sample size calculation
- Select and implement research questions and hypotheses which are aligned to core statistical principles.