Which phase of the clinical trial process involves a sample of 100-200 patients to confirm the benefits and safety of a treatment?

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BlackTom AI · Accepted Answer

Question restatement: Which phase of the clinical trial process involves a sample of 100-200 patients to confirm the benefits and safety of a treatment?

Option a) Phase 4: This phase occurs after a drug is approved and marketed. Its focus is on long-term safety, rare adverse events, and real-world effectiveness, not on confirming initial benefits in a controlled trial with hundreds of participants.

Option b) Phase 3: Phase 3 trials involve large groups to confirm efficacy and monitor adverse effects, often in hundreds to thousands of participants, but they typically enroll more than 200 subjects and aim to establish comparative effectiveness against standard treatments.

Option c) Phase 1: Phase 1 trials are the first-in-human studies, usually with a small number of healthy volunteers or patients to assess safety, tolerability, and pharmacokinetics. The sample size is much smaller than 100-200 and the primary goal is not efficacy confirmation.

Option d) Phase 2: Phase 2 trials enroll a moderate number of patients, commonly in the range of about 100-200, to evaluate preliminary efficacy and further assess safety and dosing. This phase is designed to confirm that the treatment shows benefit and acceptable safety before proceeding to larger phase 3 studies.

Why the other options are not fitting: Phase 4 does not establish initial benefits; Phase 3 involves larger populations and more definitive efficacy testing; Phase 1 focuses on safety with small cohorts and pharmacology, not confirmation of benefits. The described 100-200 patient sample size and purpose align best with Phase 2, which serves as the intermediate step to validate efficacy signals and safety in a moderately sized group before larger-scale trials.

Which phase of the clinical trial process involves a sample of 100-200 patients to confirm the benefits and safety of a treatment?

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