2.8 Interpretation of the clinical evidence

Page last updated: September 2016

2.8.1   Evidence interpretation

Summarise the clinical evidence presented in the submission (without repeating evidence from other sections). Consider:

• the level of the evidence, taking account of the directness of the comparison (Subsection 2.2)
• the quality of the evidence (Subsection 2.3)
• the clinical importance and patient relevance of the effectiveness and safety outcomes (Subsection 2.4)
• the statistical precision of the evidence (Subsections 2.5 and/or 2.6)
• the size of the effect (Subsections 2.5 and/or 2.6)
• the consistency of the results across the clinical trials presented (Subsections 2.5 and/or 2.6).

Example:

The submission is based on two randomised trials of [proposed medicine] versus [comparator]. One trial was open-label, and one trial was blinded. However, since the primary outcome is overall survival and there was little crossover, knowledge of allocation is unlikely to affect the results. The primary outcome and several secondary outcomes are highly patient-relevant. The results showed that [proposed medicine] resulted in a statistically significant improvement in survival compared with [comparator]. The improvement in median survival was 4.5 months, and this is considered to be clinically important and patient-relevant. Both trials reported a similar improvement in survival. For most patient-relevant outcomes (use of pain medication, tumour-related symptoms), [proposed medicine] showed an improvement compared with [comparator], with the key exception of quality of life, where the differences were not statistically different but favoured [comparator] early in the trials. This may be explained by the more commonly reported nausea and bowel symptoms reported by patients in the [proposed medicine] arm.

2.8.2   Therapeutic conclusion

The interpretation of the clinical data presented in Section 2 is crucial in determining the success of the submission. It is important to classify the therapeutic profile of the proposed medicine in relation to its main comparator (ie whether it is therapeutically superior, inferior or noninferior to the comparator).

The therapeutic conclusion should be a simple and unequivocal statement that is supported by evidence provided in the submission.

Example:

[Proposed medicine] is superior/noninferior/inferior in terms of effectiveness compared with [comparator].

[Proposed medicine] is superior/noninferior/inferior in terms of safety compared with [comparator].

It may be appropriate to describe the treatment regimen rather than simply the proposed medicine or the comparator, particularly if either or both are delivered in combination with other treatments or for differing durations. The description should be short, yet capture important aspects of the proposed treatment (eg [proposed medicine] in combination with [medicine X], and administered until recurrence or for a maximum of 18 cycles is superior in terms of effectiveness compared with [comparator] given in combination with [medicine X] administered until recurrence).