How Clinical Trials Work

Phase 1:

- A small group of healthy volunteers (20-100 people) are given the drug to determine its safety.

- Its tolerability and the side effects are monitored carefully.

- The primary objective of this phase is to determine the maximum tolerated dose (MTD).

Phase 2:

- The drug is given to a larger group of patients (100-300 people) with the disease or condition being studied.

- This phase aims to further assess the safety and effectiveness of the drug and identify common side effects.

- The optimal dosage and duration of treatment are explored, and preliminary information on its efficacy is gathered.

Phase 3:

- The drug is tested on a large number of patients (1,000-3,000 or more) with the disease or condition being studied.

- This phase provides substantial evidence of the drug's effectiveness, compares it to existing treatments (if available), and further evaluates its safety.

- The data collected in this phase is critical for regulatory approval.

Phase 4:

- After the drug is approved and available on the market, additional studies may be conducted to monitor its long-term safety and effectiveness.

- This phase helps identify rare side effects, drug interactions, and the drug's impact on specific subpopulations (such as children or the elderly).

Please note that the number of participants mentioned in each phase is approximate and can vary depending on the specific clinical trial.