Table 3.

Questions for sponsors to consider in deciding if a protocol simulation design would be of value

Is there a significant unmet patient need?

Are there recent changes in standard of care?

Does the sponsor have significant internal/current expertise in designing similar studies (indication and mechanism of action)?

Does the sponsor expect difficulty in enrolling patients (based on the study design and/or competitive landscape)?

Based on the protocol design, does the sponsor expect a high dropout rate or poor compliance to study visits/procedures?

Are there significant design challenges that might benefit from patient insights/input?

Does the sponsor think that the draft protocol is too complex?

Does the sponsor understand moments pre-/on-/post-study that matter disproportionately to the patient?