Online Course

Missing data in Clinical Trials

16/09/2024 - 10:00 - 12:00

Course Topics:

Background
Primary analysis and sensitivity analyses to address missing data (imputation methods)
Use of data collected after discontinuation of assigned treatment
ITT, and use of data from subjects with only baseline measurements

Background on Missing Data:

Has become a focus area for regulatory authorities (FDA, EMA)
FDA initiated and supported a report from the National Academy of Sciences (NAS) on missing data (published in 2010)
Basic principle for clinical trials: randomize to achieve comparable groups
Drop-outs may lead to non-comparable groups
Concern: those who drop out are different from those who don’t
Difficult to provide general solutions
Differences between therapeutic areas

Key Advantages of Understanding Missing Data:

Improved Regulatory Compliance: Ensures adherence to FDA and EMA guidelines, reducing the risk of regulatory issues.

Enhanced Data Integrity: Mitigates the impact of drop-outs, leading to more reliable and comparable results.

Informed Decision-Making: Provides robust methodologies for handling missing data, aiding in accurate interpretation of clinical trial outcomes.

Dr. Gil Harari, founder and CEO of Medistat, has been providing biostatistics services to top biomedical companies for 20 years. He holds a PhD in Epidemiology and Biostatistics from the University of Haifa and specializes in biostatistics for clinical trials. An expert in data mining, he lectures at Haifa University's School of Public Health and authored "Statistics in Medicine." Dr. Harari also serves as a statistical consultant, aiding companies with regulatory submissions.

About the Lecturer: Dr. Gil Harari

Who Should Attend?

This course is ideal for doctors, researchers, coordinators, research assistants, and anyone involved or interested in research and scientific writing.

Are the Lessons Recorded?

Yes, each session is recorded and made available to students immediately after the course concludes.

What Are the Payment Options?

You can pay for the course via PayPal or bank transfer.

Cost: 450 NIS