The significance of risk-based monitoring increased further since 2019, as the clinical trial management landscape faced disruptions and delays caused by the COVID-19 pandemic. Once again, the industry had to adapt, this time to the new normal of “remote” site visits. Video calls became the primary means of connecting and communicating, while documents were scanned for off-site review and data verification.
Now, one year after the COVID-19 pandemic, the era of decentralization appears to be fully realized. A late 2020 survey conducted by Oracle Life Sciences indicated that 76% of surveyed trial organizations were investing in decentralized clinical trials (DCTs). According to the FDA, decentralized clinical trials are executed through telemedicine and mobile/local healthcare providers, utilizing processes and technologies that differ from the traditional clinical trial model. These trials are conducted remotely, with patients remaining at home for the majority of the trial duration. Interactions with sites occur through software, phone applications, and connected devices, enabling critical trial data exchange and face-to-face connections with investigators using technology.
In contrast to traditional clinical trials that required patients to visit a facility for screening, consenting, and enrollment, decentralized trials offer more options for remote interactions. Many touchpoints, including screenings, consent, enrollment, and data collection, can be conducted remotely using technology. This flexibility in trial design allows for a diverse range of data collection methods in DCTs, such as electronic patient-reported outcomes (ePROs), wearable devices, telemedicine, electronic health records (EHRs), and mobile health (mHealth) apps. By collecting data remotely, DCTs reduce the burden on participants and increase study participation rates.
While decentralized trials offer several advantages, including improved access to trials and better participant retention, there are challenges to overcome. Training site staff and participants in using technology and providing tools can be demanding, and the cost of tools and data access remains high. It is crucial to address these challenges and continue exploring innovative solutions as we look to the future.