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In which phase of studies do researchers administer the drug to a group of patients with the disease or condition for which the drug is being developed?
Phase 1
Phase 2
Phase 3
Phase 4
The correct answer is: Phase 2
In the context of clinical trials, Phase 2 studies are specifically designed to assess the efficacy of a drug in a target patient population who have the disease or condition the drug is intended to treat. During this phase, researchers administer the investigational drug to participants that meet the specific criteria for the disease, enabling the evaluation of how well the drug works and its potential benefit. The primary focus in Phase 2 is to determine the therapeutic effect of the drug while also monitoring for any side effects or adverse reactions. This phase typically follows Phase 1, where the drug is tested for safety in a smaller group of healthy volunteers, and precedes Phase 3, where the drug is given to a larger population to confirm effectiveness, monitor side effects, and compare it to standard or equivalent treatments. Phase 4 occurs after the drug has been approved for marketing and involves post-marketing surveillance to monitor the drug's long-term effectiveness and safety in a broader population. Thus, the administration of the drug specifically to patients with the disease occurs in Phase 2, making it the correct choice.