Clinical Trials and Biostatistics

*Please note that applicants to this short course should go via King's Apply (click red 'Apply' button on the right of this page) and select the following programme*:

Pharmaceutical Medicine Non-Award (Part-time): Module Code 7MCS0015

This module provides training over five days on clinical trial design, analysis and interpretation. The module highlights the mutual importance of the contribution of both clinical and statistical teams. This module aims to provide a broad understanding of statistics and data management as they apply to medicines development, including those used in clinical trials, to enable a power calculation to be done, to organise clinical trial data and to analyse and report the data. The module will consist of classroom teaching with a large element of practical experience designing studies and evaluating, analysing and presenting data.

• Illustrates the core activities of clinical development including the design of clinical trials including the endpoint selection, statistical principles and data management.
• Provides a broad understanding of statistical concepts as they apply to the development of medicines, including those used in clinical trials.
• Enables the student to learn key statistical skills for example, to enable a power calculation to be done, to organise clinical trial data and to analyse and report the data.
• Provides students with a more detailed understanding of different study designs, including non-experimental as well as adaptive and Bayesian designs.
• Give students an understanding of the importance of ‘clean’ clinical trial data collection from Case Report Forms and other sources and data standards.

By the end of this module students will be able to:

• Create a clinical protocol.
• Critically appraise data collection and data management plans with a view to securing clean data in line with the data analysis plan.
• Critically appraise the use of statistical techniques in the robust design for a clinical trial, including decisions on type 1 and type 2 errors and running power calculations.
• Understand the advantages and disadvantages of various study designs and techniques to avoid bias.

Minimum entry requirements are either a medical degree (such as an MBBS) or a 2:1 first degree in pharmacy, pharmacology, biology, biochemistry, chemistry or related subject. The course will suit individuals seeking to develop a practical understanding of importance of clinical trial design and biostatistics in medicine development by the pharmaceutical industry e.g. pharmaceutical physicians, scientists in R&D and medical affairs, and regulatory affairs personnel.