|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.
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.
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 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.|