DCTs have several advantages as denoted above but they are not a magical bullet either. DCTs require extensive levels of coordination to avoid patient burn-out (e.g., redundant applications, at home data collection challenges, behavioral incentives, etc.). DCTs face shifting regulatory modalities (e.g., telemedicine, direct-to-patient product shipments, etc.).
DCTS also require a new skillset relative to design, operations, and execution of the trial itself. Gone is the ability to house all your resources under “one-roof”. Rather for a DCT to be successful you need a strong master data management (MDM) strategy, industry leading data security mechanisms, sophisticated data analytics, solid distribution operations, and hands on partnerships with experienced global project management firms to handle the hundreds of intricacies which arise from at-home clinical trials.