Table 2.

Considerations regarding standardization of treatment

Favors more standardized treatment	Favors more naturalistic or variable treatment
Treatment effectiveness or safety are not expected to vary among clinicians or clinical settings	Treatment effectiveness or safety varies according to available clinical resources or expertise
Standardized study treatment more likely to match treatment in settings where results will be applied	Naturalistic or variable study treatment more likely to match treatment in settings where results will be applied
Standardization of treatment necessary for valid inference regarding safety or effectiveness	Standardization would obscure differences in safety or effectiveness likely to occur in subsequent real‐world care
Standardization of treatment necessary to protect vulnerable participants or assure participant safety	Standardization of treatment not necessary to protect vulnerable participants or assure participant safety