| General considerations regarding clinical trials Lunn et al. [1] |
Detailed description of the general considerations
Lunn et al. [1] |
Ethical considerations |
Related basic ethical principles |
| Inclusion/exclusion criteria for patients |
Early stage or late stage patients? |
Provide equitable access of research subjects or patients (fairness) |
Justice |
| Realistic expectations |
Informed consent forms must tell the patient about the trial |
Informed consent |
Respect for autonomy |
| Safety trials versus efficacy trials |
Health impact
Risk-benefit analysis |
Beneficence and nonmaleficence |
| Expectations of therapeutic effect |
Health impact
Risk-benefit analysis |
Beneficence |
| Immunosuppression |
Immunosuppression may increase the survival of graft tissue |
Health impact
Risk-benefit analysis |
Beneficence and nonmaleficence |
| Potential side effects |
Prevent or minimize potential side effects (for instance tumor formation) |
Health impact
Risk-benefit analysis |
Beneficence and nonmaleficence |
| Risk versus quality of life |
Health impact
Risk-benefit analysis |
Beneficence and nonmaleficence |
| Safety of cellular therapy administration |
Pros and cons of systemic delivery, lumbar puncture, or stereotactic injection |
Health impact
Risk-benefit analysis |
Beneficence and nonmaleficence |
