Clinical Trials

• Clinical Trials

  1. Vaccines and drugs are subjected to clinical trials to establish their safety and effectiveness before being licensed for use. 
  2. The design of clinical trials to test vaccines and drugs involves randomised, double blind and placebo-controlled protocols. 
  3. Subjects in clinical trials are divided into groups in a randomised way to reduce bias in the distribution of characteristics such as age and gender E.g. picked by computer so equal chance of being in either group
• Clinical Trials

  4. In a double blind trial neither the subjects nor the researchers know which group subjects are in to prevent biased interpretation of the results.

  5. One group of subjects receives the vaccine or drug while the second group receives a placebo –control to ensure valid comparisons.
• Importance of large groups in clinical trials

  6. 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

  7. Results are then compared to determine whether there are any statistically significant differences between the groups.