Question

Phases of clinical trial.

Hint:

The goal of clinical trial phases is to progressively gather data on safety and efficacy before a new treatment is approved for general use.

Answer 1

Clinical trials are conducted in different phases to evaluate the safety, efficacy, and dosage of new interventions or treatments. The phases are as follows:
Step 1: Phase I (Exploratory Phase):
- The first stage involves testing a new drug or treatment on a small group of healthy volunteers (20-100 participants) to assess its safety, determine a safe dosage range, and identify any side effects.
- This phase is mainly focused on safety.
Step 2: Phase II (Expansion Phase):
- This phase involves a larger group of people (100-300 participants) who have the condition the drug is intended to treat. The focus is on evaluating the treatment's effectiveness and further assessing safety.
- Preliminary efficacy is also measured, but long-term effects are not fully studied.
Step 3: Phase III (Confirmatory Phase):
- In this phase, the treatment is tested on a much larger group (1,000-3,000 participants) to confirm its effectiveness, monitor side effects, and compare it to standard or placebo treatments.
- Phase III results help regulators decide whether to approve the drug for widespread use.
Step 4: Phase IV (Post-Marketing Surveillance):
- This phase takes place after the drug has been approved and marketed. It monitors the long-term effects and overall safety of the drug in the general population.
- It helps identify any rare or long-term adverse effects that may not have been observed in earlier phases.