TABLE 1.

Checklist

Trial Design Consideration	Methods	Approach
Classify rurality of participants13	On the basis of the goals of the study, identify a rural classification coding system to guide target recruitment and/or characterize study participants  RUCC—County-level classification of rurality on the basis of   population and proximity to metropolitan areas  RUCA Codes—Census tract and zip code classification of rurality   on the basis of geographic proximity and commuting flow into and out of urban centers  UIC—County-level classification on the basis of proximity to   nearest metropolitan area  FAR Codes—Zip code level classification on the basis of travel   time by car to nearest urban area Codes can be used to reflect rural residency at the level of the individual, however could also be used to delineate rurality at the clinic site level	Use a classification system to delineate between urban and rural study participants for accrual tracking Consider if an objective of the study is to target enrollment of rural populations and choose a classification system that aligns with the study intent to establish enrollment thresholds  eg, >50% of enrollment will be among patients residing in RUCC 4 and above areas
Low burden imaging	Minimize repeated imaging tests within the trial. Use an approach that is least-intrusive as possible Minimize the number of complex imaging tests	Consider partnerships with rural hospitals or health care centers for repeat imaging Identify mobile imaging units, if available, as potential partners Align with NCCN current guidelines for standard of care Consider insurance coverage barriers when exceeding established standards of care Broader window of image eligibility (eg, minimum of 4 weeks) Allow consideration of anatomic imaging (CT) in lieu of functional imaging (PET), when appropriate
Remote consent	Make available to all participants	Continue to allow phone consenting with witness for remote consent Collaboration and training with local health care or community centers/extension offices
Telehealth/mobile technology	Leverage to provide  Educational interventions  Patient-reported outcomes measures  Symptom and toxicity tracking	Consider app-based symptom tracking systems Expanded collaboration with local providers giving access and roles on (decentralized) clinical trial platforms (eg, Commercial Off-the-Shelf platforms like Thread Castor, Clin Capture, built into EHR if available)
Financial support for rural patients	Budget for or collaborate with local foundations to provide transportation incentives to individuals traveling a certain distance to study site Budget for or collaborate with local foundations to provide accommodations for individuals who travel extensively for trial participation	Partner with county or state services for transportation or accommodations needs Budget for transportation incentives, such as gas cards or ride share vouchers per patient The tank of gas is a significant incentive and holds both important practical and symbolic significance
Local care delivery	Identify standard-of-care trial procedures that could be carried out at local clinics or provider offices including  Local drug delivery  Biospecimen collection  Imaging	Provide training to local providers and collaborate on standard drug delivery (eg, delivery of standard of care drug agent could be administered locally [Taxol] without requirement to travel)
Rural recruitment strategies	Consider community advisors from rural health offices Communication with local primary care provider regarding patient eligibility for trial enrollment	Use community events and organizations to socialize clinical trials with the community Conduct informational sessions with local community groups for knowledge and awareness

Abbreviations: CT, computed tomography; EHR, electronic health record; FAR, Frontier and Remote; NCCN, National Comprehensive Cancer Network; PET, positron emission tomography; RUCA, rural–urban commuting area; RUCC, rural–urban continuum codes; UIC, Urban Influence Codes.