Table 3.

Other key considerations in exercise oncology clinical trials

Consideration	Description
Dose quantification	Complete description of the exercise intervention is required and includes full reporting of exercise prescription and principles of training.71
Novel trial designs	Adaptive trial designs in which pre-planned modifications are made based on interim feasibility data may be more appropriate for investigations of longer-term interventions such as exercise, than traditional dose escalation designs (e.g., “3 + 3”). The continual reassessment method is an adaptive design that utilizes a model-based approach for phase 1 studies and allows for the consideration of toxicities that may occur late in the observation period.72–74
Biological activity	Markers of pharmacokinetic activity traditionally used to evaluate new drug compounds are of limited value for the assessment of exercise; biological activity should be evaluated by pharmacodynamic assessments.
Quality reporting	Conduct and reporting of clinical trials must adhere to high-level quality standards in order to optimize interpretation, reproducibility, and translation into clinical practice. In drug development, the implementation of the Consolidated Standards of Reporting Trials (CONSORT) led to marked improvements in RCT rigor, standardization, and conduct.75,76 CONSORT guidance has been extended to non-pharmacologic trials (CONSORT-NPT) to account for behavioral interventions, however current guidelines are suboptimal for exercise trials since they do not provide a standardized mechanism for reporting all exercise prescription components. Adherence to quality standards can be encouraged by regulatory oversight (not currently mandated for non-pharmacologic trials including exercise).
Implementation	Effective implementation strategies are needed in which exercise dose and compliance can be accurately quantified whilst optimizing patient convenience.77Innovative strategies for effective exercise implementation are needed. Digitized and telemedicine platforms offer a promising opportunity to leverage technological advances for standardized delivery of exercise interventions in a patient-centered manner.