Preclinical and Clinical Trials

Preclinical Trials

• The drug is tested on cells in a laboratory setting.
• Computer models are used to simulate the pathways that the drug may take.
• The drug is tested on two different animal species, as required by UK law, to observe its effect in a whole organism.
• The primary focus of preclinical trials is to test the drug's toxicity.

Clinical Trials

• Clinical trials consist of three phases: Phase 1, Phase 2, and Phase 3.

Phase 1

• The drug is first tested on human volunteers with a very low initial dose, which is then gradually increased.
• The purpose of Phase 1 is to ensure the drug's safety in a normal, healthy body.

Phase 2

• The drug is tested on a small group of patients to evaluate its efficacy.
• Scientists begin to observe the drug's effectiveness during this phase.

Phase 3

• Phase 3 involves large-scale clinical trials to determine the optimal drug dose and its effectiveness in a diverse range of people, including the elderly, young, and obese.

Double Blind Trials

• A type of clinical trial where some volunteers receive the actual drug, while others receive a placebo (a fake medicine).
• The purpose of double blind trials is to ensure that the actual drug, and not the placebo effect, is responsible for the observed improvements.
• Neither the volunteers nor the doctors know who has received the real drug or the placebo in a double blind trial.

Post-Trial Procedure

• After the trials, the drug undergoes peer review, where scientists review and critically evaluate each other's work.

This quiz covers the stages of drug testing, from laboratory and animal testing to human clinical trials, including Phase 1 dosing and safety testing.