TABLE 5.

Points to consider in relation to patient selection.

Suggested research participants for early-phase clinical trials	Reasons for and against selection
Healthy individuals	For
	- Healthy individuals are most resilient to physical harms (thus, harms are minimized)
	Against
	- No clinical value for the participant
	- Risks are too high
Individuals at risk	For
- No symptoms	- Less damage to the body from disease or disease-related complications, which could lead to better health outcomes compared to more advanced disease stages
- Risk factors for disease	- Disease can be prevented
	Against
	- Risks could be too high
	- Unnecessary treatment (participants may not develop the disease)
Early-stage patients	For
- Mild to moderate disease	- Less damage to the body from disease or disease-related complications, which could lead to better health outcomes compared to more advanced disease stages
- Medically controlled disease	Against
	- Risks are too high
	- Alternative treatment options may be available
	- Treatment could worsen the disease
Children	For
Diagnosed with the disease	- Less damage to the body
	- Serious complications can be prevented
	- Benefit can be enjoyed the longest
	Against
	- Risks may be too high
	- Alternative treatment options may be available
	- The disease may not proceed to advanced stages
	- Long-term follow-up may be burdensome for the participants
	- Children are unable to provide informed consent
Advanced-stage/end-stage patients	For
- Severe disease	- There is an unmet medical need, as effective treatment options are not or no longer available
- Unstable disease	- Potential for medical benefit from participation in the trial
- No or no longer a suitable treatment option available	- Less to lose when serious complications occur
	Against
	- The body is already damaged; this damage might be irreparable
	- Treatment could worsen the disease