Which activity directly evaluates safety and efficacy in humans during drug development?

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Clinical trials are the part of drug development where the investigational drug is tested in people to learn whether it is safe and effective. After preclinical studies in the lab and in animals, small groups of volunteers or patients enter early phases to assess safety and dosing, then larger groups are studied to evaluate efficacy and optimize dose, with even larger trials to confirm benefits and monitor adverse effects across diverse populations. This direct testing in humans provides the real-world evidence needed to judge safety and efficacy and to support regulatory decisions. High-throughput screening focuses on lab or computer-based activity, not humans. Regulatory approval is the formal decision based on the trial data, not the testing itself. Pharmacovigilance tracks safety after a drug is on the market, rather than during development.