TABLE 6.

points to consider in relation to trial design.

Trial design	Points to consider
Intervention	- Researchers should set up combined efficacy and safety trials
Outcomes	- Patients should be actively involved in research design as stakeholders
1. Patient-reported (e.g., quality of life, treatment satisfaction and experienced symptoms)	- PROMs should be developed for later-phase clinical trials and adopted in trial design
2. Professional defined (survival rate, functional status and biological parameters)
Skills and materials	- Learning curves of surgeons should be corrected for
	- The effects of the risks associated with surgical procedures on the outcomes of trials should be corrected