Unit 4 - Immunology and Public Health

Unit 4 – Immunology and Public Health 1. The Immune System 2. Infectious Diseases and immunity Non-specific defences Specific cellular defences Transmission and control Active Immunisation and Vaccination and the evasion of immune responses

By the end of this section you will be able to ….. 2. Infectious Diseases & immunity b) Active immunisation, vaccination and evasion By the end of this section you will be able to ….. state why clinical trials are important describe what is meant by a randomised, double blind, placebo-controlled protocol.

How does a new drug make it your cabinet?

Clinical research animation Video Clinical Trials Vaccines are subjected to clinical trials in the same way as other pharmaceutical medicines to establish their safety and efficacy (capable of producing the intended result) before being licensed for use. Clinical Trials protocols MUST be: Randomised Double-blind Placebo-controlled Clinical research animation Video

Randomised & Double-Blind protocols Subjects are split into groups in a randomised way in which neither the subjects nor the researchers know which group they are in to eliminate bias.

Placebo-Controlled Protocols One group of subjects receives the vaccine, while the second group receives a placebo control (no medical value) to ensure valid comparisons. The Power of the Placebo Effect video

Large Scale Studies At the end of the trial, results from the two groups, which must be of a suitable size to reduce the magnitude of experimental error, are compared to determine whether there are any statistically significant differences between the groups

More videos Ben Goldacre on Placebo effect http://www.youtube.com/watch?v=wsFTgirKXHk How to run randomised control trials http://www.youtube.com/watch?v=U50VP6E2dYw Randomised control trials – Ben Goldacre http://www.youtube.com/watch?v=RzRs7cPrrfE

Can you now …. state why clinical trials are important describe what is meant by a randomised, double blind, placebo-controlled protocol.