PAAB code section 5.7 states:
PAAB frequently receives questions relating to the terms “subjective” and “objective” in this section of the Code.
The term “subjective endpoints” refers to variables whose values are vulnerable to systematic bias from EITHER i or ii:
Blinding is not required in cases where the variable is vulnerable NEITHER to subject knowledge of group assignment NOR researcher knowledge of the subject’s group assignment (e.g. overall survival rate or blood cholesterol levels measured using a digital meter). These are examples of objective endpoints.
In cases where the variable is vulnerable only to one of the party’s knowledge of the subject’s group assignment, a methodology blinding only the vulnerable party will satisfy s5.7. For example, in some cancer studies, only the assessor interpreting the scans for tumor presence and/or size are blinded.
Unsure about whether a study meets the blinding provisions discussed in PAAB 5.7? Submit an opinion to PAAB with your specific query. See the fee schedule on our website for details. Comparative claims of efficacy and safety generally require support of evidence from head-to-head well-designed, adequately controlled, blinded, randomized clinical studies. Open-label studies are generally not considered to be a high level of evidence and are not acceptable if subjective end-points are included in the study. Comparative claims should be relevant to current medical opinion and practice.