Decentralized Clinical Trials: Essential Tips To Avoid Common Pitfalls

The shift to DCTs has numerous advantages. Remote solutions for maintaining site visits and drug delivery activities in a variety of situations allowed trials to continue during the global COVID-19 crisis. Such solutions also provide participants with more choice regarding how they engage in studies: patients can now potentially choose between going to a study site or speaking to the study doctor via a televisit and can complete their PROs anywhere. This can lead to a significant reduction in the burden associated with clinical trial procedures, by removing need for patient transportation and paper documentation. Study patients can also choose to use their own smartphone or a provisioned device to complete their eDiary. All this gives a tremendous level of flexibility to study patients and mirrors the lifestyle technologies they are now accustomed to using routinely.

Despite these advantages, reducing on-site visit means that data endpoints need to be captured via other means. Data must not be lost when patients do not come to site for several weeks, data quality must be guaranteed throughout the project, and data must be protected even when patients use their own mobile.

How can the common pitfalls that come with DCTs be avoided?