8. Regulatory agencies care more about the “what” of a clinical trial than the "how."Group of answer choicesTrueFalse
Question
8. Regulatory agencies care more about the “what” of a clinical trial than the "how."
Group of answer choices
- True
- False
Solution
In the context of clinical trials and regulatory agencies, the statement "Regulatory agencies care more about the 'what' of a clinical trial than the 'how'" can be interpreted in terms of the emphasis that these agencies place on the results (the outcomes, or "what") versus the methodology (the procedures and processes, or "how").
Regulatory agencies, such as the U.S. Food and Drug Administration (FDA), are indeed primarily concerned with the effectiveness and safety of a drug or treatment, which relates to the "what." They want to ensure that trials yield valid results and that any new drug will benefit patients.
However, the "how" – the methodology and compliance with ethical standards during the trial – is also crucial, as it influences the reliability and validity of the results.
Thus, while the statement has some truth, it may oversimplify the nuanced perspective of regulatory agencies. Both aspects are significant in the approval process. Therefore, the answer is:
False.
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