What type of trials does ICH E6 Section 4.8.13 refer to?

What type of trials does ICH E6 Section 4.8.13 refer to?

• A. Therapeutic trials
• B. Non-therapeutic trials
• C. Experimental trials
• D. Placebo-controlled trials

Answer: (B)

ICH E6 Section 4.8.13 specifically addresses non-therapeutic trials, which are designed primarily for research purposes rather than for direct therapeutic benefit to participants. This section involves the guidelines for the ethical and scientific conduct of trials where the primary aim is to collect data or investigate hypotheses without providing a direct health benefit to the trial subjects. In non-therapeutic trials, the focus is generally on obtaining evidence related to safety and efficacy rather than on treating existing conditions. This distinction is crucial in ensuring that participants are aware of the nature of the trial they are participating in and the risks they may encounter, aligning with ethical considerations in research. Other trial types, such as therapeutic, experimental, or placebo-controlled, do not encompass the specific focus on trials that are not meant to provide direct therapeutic benefit, hence they are not covered under this guideline section.

ICH E6 Section 4.8.13 specifically addresses non-therapeutic trials, which are designed primarily for research purposes rather than for direct therapeutic benefit to participants. This section involves the guidelines for the ethical and scientific conduct of trials where the primary aim is to collect data or investigate hypotheses without providing a direct health benefit to the trial subjects.

In non-therapeutic trials, the focus is generally on obtaining evidence related to safety and efficacy rather than on treating existing conditions. This distinction is crucial in ensuring that participants are aware of the nature of the trial they are participating in and the risks they may encounter, aligning with ethical considerations in research.

Other trial types, such as therapeutic, experimental, or placebo-controlled, do not encompass the specific focus on trials that are not meant to provide direct therapeutic benefit, hence they are not covered under this guideline section.