Biostatistics & Research · single question
For the study of a NEW DRUG, what is MOST relevant?
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Correct answer: B. Placebo use (control group)
Placebo use (B) is most relevant in new drug studies. A placebo control is essential for:
• Eliminating the placebo effect — improvement due to patient expectation rather than drug effect
• Establishing a true comparison baseline
• Determining whether any observed effects are due to the drug itself
• Double-blind, placebo-controlled RCT is the gold standard for new drug trials.
• Single-blind (A): only the patient is blinded — the researcher knows which group is which → potential for observer bias.
• Double-blind: both patient and researcher are blinded → eliminates both placebo effect and observer bias.
• For drug trials, placebo use is an ethical requirement (when no established effective therapy exists) per Declaration of Helsinki guidelines.
• Eliminating the placebo effect — improvement due to patient expectation rather than drug effect
• Establishing a true comparison baseline
• Determining whether any observed effects are due to the drug itself
• Double-blind, placebo-controlled RCT is the gold standard for new drug trials.
• Single-blind (A): only the patient is blinded — the researcher knows which group is which → potential for observer bias.
• Double-blind: both patient and researcher are blinded → eliminates both placebo effect and observer bias.
• For drug trials, placebo use is an ethical requirement (when no established effective therapy exists) per Declaration of Helsinki guidelines.
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