By Mark Maietta, President, YPrime
Decentralized clinical trials (DCTs) enable patients to enroll and participate while minimizing or eliminating travel to a central investigator site, often by leveraging the use of technology. However, ill-conceived implementation of DCT solutions, particularly as it relates to technology, can increase burdens on the site, patients, and/or sponsors.
Conversely, deft implementation of DCT solutions can help sponsors to overcome difficulties that almost all clinical trials encounter, whether the challenges are patient-centric (e.g., recruitment and retention), site-centric (e.g., overburdened site coordinators), or operational (e.g., costs and timelines). To achieve positive outcomes, DCT solutions must be considered while identifying and prioritizing how a strategy or technology may grant efficiencies in one area while simultaneously generating complex issues in another.
Seek a technology provider that can deeply discuss options, outcomes, and concerns surrounding the protocol and potential technologies, as well as how each technology may or may not fit based on the trial protocol, site setup, and patient population. They also should be able to talk about how other, ancillary technologies might be useful and fit within the trial’s ecosystem — throwing every technology that seems like it might help at a trial ignores the necessity of understanding daily site operation or a day in the life of a study participant, within that trial’s schedule of events, enduring burdens associated with that disease.