Table 3.

Barriers to Implementing a Senolytic Trial in Skilled Nursing Facilities and Potential Solutions

Skilled nursing facilities are often understaffed	Trial design that involves research team member entering the facility to administer drug/placebo and perform assessments, then monitoring for any adverse events remotely via health system electronic medical record. Other than sharing a portion of new Minimum Data set assessments with the research team when they occur, there is no work required by facility staff for study participants.
Potential skilled nursing facility leadership concerns about liability	Implementation of a memorandum of understanding, signed by the sponsoring institution for the study as well as facility leadership, outlining expectations of each party and making clear that the facility is not the research participant (rather the patient/resident is) and bears no legal responsibility for any trial outcomes.
Challenges in obtaining consent for institutionalized patients, potentially with cognitive impairment	Protocol allows consent to be obtained via phone and/or electronically, utilizing the participant’s legally authorized representative when appropriate.
Concerns about ability of research team to enter facility during pandemic restrictions	Trial conducted at a point during the pandemic when visitation/entry restrictions have relaxed due to fairly widespread vaccination and improving case/mortality numbers. Ensuring research team members are trained in infection control and personal protective equipment use.
Challenges in delivering and storing Fisetin	Trial medication will be picked up from the research pharmacy by the study research nurse and delivered to the subject for administration. Fisetin is stored refrigerated for stability, once dispensed, Fisetin is stable in ambient conditions until administration, typically within 2–4 hours.
Potential for participants, particularly if in the facility only for a short-term stay, to relocate during the trial	Protocol design to minimize in-person assessments and sample collection to only those instances that are strictly necessary. After initial 14 days of the study, follow-up is very infrequent, and can largely be accomplished remotely.
Lack of familiarity with clinical trials among facility staff/leadership	Inclusion of skilled nursing facility medical directors on the research team and early engagement (months before enrollment begins) by said medical directors with facility leadership, including multiple methods of communication (written and verbal) as well as question/answer sessions to ensure facility leadership are comfortable with the study.