Discuss the basic characteristics (and/or considerations) when determining what the primary efficacy endpoint IN GENERAL is going to be in a Phase III pivotal trial. Try your best to write well.
Include:
Introduction – frame your topic and let the reader know where you’re going
One primary efficacy endpoint (versus multiple co-primaries) & the issue of multiplicity
Measurability
Practicality and clinical relevance
What’s been done before — “the regulatory landscape” – have similar endpoints been used?
Other indication-specific; disease state-specific etc.
Other characteristics you think of that are not mentioned here — e.g., climate of opinion affecting the submission environment because of the news – are these endpoints going to provide a better solution?
Brief Conclusion (1-2 sentences)
Limit yourself to 10 or fewer quality references for this paper. You may have less.
