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Clinical studies are essential to advancing medical science and developing new treatments. These studies follow a structured process, divided into phases, each designed to answer specific questions about the safety, and efficacy of new drugs, therapies, or interventions.
In this post, we’ll explore the different phases of clinical trials, breaking them down into easily understandable segments, complete with examples.
TL:DR
Preclinical: Lab and animal testing to evaluate potential.
Phase 1: Focus on safety and dosage in a small group.
Phase 2: Test for effectiveness in a larger group.
Phase 3: Confirm effectiveness and monitor side effects on a large scale.
Phase 4: Post-approval monitoring for long-term safety and efficacy.
Preclinical Research: Laying the Groundwork
Before a new drug or treatment reaches human testing, it undergoes preclinical research.
This phase involves laboratory experiments and often animal studies to assess the treatment’s potential safety and effectiveness.
The goal here is to gather enough evidence to justify moving forward with human trials.
Example: Suppose a pharmaceutical company is developing a new cancer drug. In the preclinical phase, the drug would be tested on cancer cells in a lab and in animals to see if it reduces tumour size without causing severe toxicity.
If preclinical results are promising, the drug moves on to human trials.
Phase 1: Testing Safety in Humans
In Phase 1, researchers focus primarily on safety. The study usually involves a small group of 20–100 participants and aims to determine the safest dose range and identify side effects. It’s the first time the drug is tested in humans, and participants are closely monitored.
The goal here is to determine the drug’s safety and dosage in a small group of healthy volunteers (or sometimes…
