Table 1.

Strategies for Continuing a Clinical Research Study When In-Person Contacts Are Restricted

Study component	Potential strategy
Baseline assessment	1. Convert if possible to virtual (remote) assessment by audio (if only patient-reported outcomes are required) or video (if patient observation or performance is required) 2. If study cannot convert to remote assessment, delay baseline assessment until in-person contacts are permitted
Follow-up assessment	1. Same as strategy #1 for baseline assessment 2. If study cannot convert to remote assessment and has assessments at multiple time points, drop one (or more) of the assessments for these participants. Repeated measures or imputation strategies can deal with missing assessments. 3. If near the end of the in-person ban period, delay the assessment if possible to do so within a reasonable time window
Intervention—subject has not yet started	1. Delay intervention until in-person ban has been lifted (and decide if study needs to re-do eligibility interview at that time)
Intervention—subject has started	1. Convert if possible to a virtual (remote) intervention delivery 2. If study cannot convert to remote delivery, suspend for several months until the in-person contact ban is lifted. Then pick up where study left off. For example, if study delivered sessions 1–3 of a 6-session intervention, finish sessions 4–6 after in-person ban is lifted 3. If study cannot pick up where it left off, consider restarting the intervention after in-person ban is lifted (a downside is a subgroup of participants will get a “double dose” for repeated sessions).
Other issues	1. Try to avoid dropping enrolled subjects if at all possible 2. Clear major study changes with IRB and study sponsor 3. Enroll a larger number of participants if possible to compensate for the pandemic-related subgroup should the latter affect the results 4. Use secondary analytic strategies (e.g., analyzing study results with and without pandemic-related participant subgroup; adjusting for pandemic subgroup as a covariate; etc.)