Table 1 Implementation outcomes framework applied to the clinical trial context

Acceptability

Perceived existence of equipoise between intervention arms

Anticipated or possible benefit to a participant over existing options

Acceptable anticipated side effect profile

Reasonable participant logistics (e.g., number of clinic visits, distance traveled to the trial site)

Reasonable additional clinical burden (e.g., minimal additional biopsies or other invasive procedures)

Additional direct time and financial cost to participants is acceptable to participants

Adoption

Proportion of providers offering clinical trials to patients

Appropriateness

Question is amenable to a clinical trial

Trial design is appropriate for the trial question

Feasibility

Possible to meet enrollment goals

Timeline for enrollment and completion is reasonable

Anticipated effect size is reasonable

Fidelity

Amount of intervention group crossover

Adherence to trial protocol including follow-up

Implementation cost

Cost of trial administration

Cost of trial intervention vs. standard of care (during trial)

Cost of additional trial staff required

Cost of additional study components (surveys, labs, scans, biopsies)

Penetration

Proportion of eligible patients being offered trial

Proportion of eligible patients offered trial who enroll in the trial

Proportion of patients in the global population represented by trial eligibility criteria

Sustainability

Maintenance of accrual rates after trial opens

Sustained physician interest (i.e., physicians continue offering trial to patients throughout the trial period)

Sustained participant interest throughout the trial period

Continued provision of standard of care after the trial concludes