What does "trials conducted 'in patients'" imply in Principle 4?

The phrase "trials conducted 'in patients'" in the context of Principle 4 specifically points to trials that involve actual patients who require medical care. This designation is crucial as it emphasizes that the trials are designed to assess the effectiveness and safety of a treatment or intervention in individuals who are not only suffering from a specific condition but also may benefit from the new treatment being studied.

In the realm of medical research, distinguishing between trials involving patients and those involving healthy volunteers or laboratory studies is important for understanding the applicability of the results. Trials "in patients" are essential because they reflect real-world scenarios and the complexities of treating individuals with various health conditions. They provide insights that are directly relevant to clinical practice and patient care, thereby enhancing the validity of the findings regarding the treatment's efficacy and the patient population affected.

This focus on actual patients highlights the ethical and clinical importance of conducting studies in populations who stand to benefit from new medical insights, as opposed to scenarios involving healthy individuals or non-clinical settings, which do not directly address the needs of those who are ill.