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Table 1 Features of trials appropriate for clinically-integrated versus more traditional randomized trials.

From: The clinically-integrated randomized trial: proposed novel method for conducting large trials at low cost

  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.