Several strategies exist to bring studies closer to participants and reduce the number of visits a participant has to make to the study site. By sending the investigational product to the participant, visits to the site may be eliminated/reduced, however other logistical responsibilities may be assigned to the participant. Direct to participant investigational product may be an attractive strategy, depending on the study and study population.
Direct to participant approaches may increase burden on patients and sites and may not be appropriate for all study populations or study types. Participants may be identifiable to the 3rd party vendor and processes must be put into place to ensure vendors do not pass the participant information to the sponsor.