Table 1.

Features of trials appropriate for clinically-integrated versus more traditional randomized trials.

	Clinically-integrated randomized trial	Traditional randomized trial
Tests, procedures, questionnaires	All data needed to address the study question would be of value for the clinician during routine follow-up. All tests, procedures and questionnaires would be given to patients irrespective of participation. Example: A test for cancer recurrence.	Some data required to answer study-specific questions would not be taken during routine care. Example: blood draw for a molecular marker thought to predict response to treatment.
Treatments	Patients very unlikely to have strong preferences for one or other treatment. Example: Two alternative suturing techniques during surgery.	Many patients may have a strong preference for one or other treatment. Example: Radical versus breast conserving surgery.
Comparisons	Can only compare two active treatments. Example: Two widely used anti-depressants of proven value.	May compare an active treatment to placebo or no treatment control. Example: Novel anti-depressant versus placebo.
Patients	Most patients are randomized.	Only a proportion of patients are randomized.
Eligibility criteria	Eligibility criteria should be minimized. Example: all patients undergoing radical prostatectomy are eligible.	Eligibility criteria can be restrictive. Example: restrictions on comorbidities in a trial of a novel drug.
Information technology	Trial depends heavily on information technology.	Trial can be lo-tech.