Drug Development Statistics and Data Management

Program Overview

This 5-day short course from King's College London provides a comprehensive overview of statistics and data management in drug development. It covers study design, data analysis, and drug safety studies, with a strong emphasis on practical application through workshops and case studies. The course is suitable for professionals in the pharmaceutical industry, including physicians, medical affairs personnel, and regulatory affairs personnel.

Program Outline

Outline:

• Course Duration: 5 days
• Course Dates: To be confirmed
• Course Aims:
• Provide a broad understanding of statistics as they apply to medicines development, including clinical trials.
• Teach key skills for designing clinical trials, organizing data, and analyzing and reporting results.
• Provide a deeper understanding of different study designs, including non-experimental, adaptive, and Bayesian designs.
• Provide an understanding of methods used in drug safety studies, including epidemiological approaches and meta-analysis.
• Course Content:
• Statistics for Medicines Development:
Covers concepts like power calculations, study design choices (superiority, non-inferiority, equivalence), avoiding bias, data review and analysis plan development, choosing the appropriate analysis techniques, and interpreting results.
• Drug Safety Studies: Covers topics like using epidemiological data to evaluate drug safety issues and critically analyzing meta-analysis plans.
• Course Structure:
• Classroom teaching with a strong emphasis on practical experience.
• Workshops for designing, evaluating, and analyzing clinical studies.
• Making oral scientific presentations to peers.

Teaching:

• Teaching Methods:
• Classroom lectures
• Interactive workshops
• Individual and group work
• Faculty:
• Experts in statistics, drug development, and data management.
• Unique Approaches:
• Strong emphasis on practical application through workshops and real-world case studies.

Careers:

• Suitable for individuals seeking intensive training in drug development statistics and data management, such as:
• Pharmaceutical industry physicians
• Medical affairs personnel
• Regulatory affairs personnel
• Provides graduates with the skills and knowledge required for a range of careers in the pharmaceutical industry and beyond.

Other:

• Minimum entry requirements are either a medical degree or a 2:1 first degree in a relevant scientific field.
• The course is offered by the Institute of Pharmaceutical Science at King's College London.
• The course fee is £2590 for full-fee students, £1670 for Home Students, and £2590 for Overseas Students.