As per the FDA, Decentralized Clinical Trials (DCT) refer to clinical trials which are executed via telemedicine and local/ mobile healthcare providers, making use of technologies and processes which are different from the traditional model of clinical trials.
Typically, such trials are conducted by remote means instead of an on-site facility and wherein patients stay at home during the complete trial process. In this arrangement, interaction with clinical trial professionals or websites takes place using connected devices, phone applications and software. Such tools feed the websites and sponsor vital data while enabling face-to-face interactions with the aid of technology, thus reducing the need for the patients to visit the trial facility significantly.
The following are the major benefits of DCT:
Reduction in burden for participants
Covid-19 has transformed the status quo for several industries, including the space for clinical trials. Participants of such trials refuse to undertake the big burdens of costs and logistics involved in traditional clinical trials. The reason is that DCTs offer the following benefits:
Fewer visits to sites
The capacity of participants to collect data and report to clinical trial professionals using apps and other remote means reduces or avoids the need to travel to sites.
Notifications and reminders
Alerts can be sent to the smartphones of patients directly to remind them to consume the medicines or/ and finish their study tasks.
Training in multi-media
Training videos offer participants a clear idea about their responsibilities as well as precise guidance about the completion of activities.
Devices and sensors
The use of cutting-edge devices and sensors often gets rid of the need for detailed reporting of patients about vitals and other measurements.
Enhanced compliance and retention
Since DCT makes easy, remote reporting by patients during clinical trials, the latter are likely to comply and stay with the trials right to their finish.
Easier tracking of patients
When there is easier monitoring of participants and any missing tasks, it helps a patient insights team to reach out to participants who may need extra support before they stop complying with the trials.
More engaged and informed participants
DCT can enhance engagement via a feedback loop which provides participants more access to their very own data. This aids them in feeling more actively engaged in the trials. More than ever, such data can be gamified, enabling participants to retain or boost their compliance level.
Improvement in accuracy
One of the major drawbacks of in-person clinical trials is the need for participants to record their data in diaries in a diligent way. The result is a ‘parking lot syndrome’, wherein participants fill up questionnaires only prior to a site visit, which leads to mistakes and inaccurate reporting of data.
Superior reporting of data
Enabling subjects of clinical trials access to apps on their smartphones and to report symptoms/adverse events as soon as they occur is a better way to record perceptions and experiences. DCT also empowers sponsors to collect real-time and highly complicated data through remote monitoring.
Less missing of data
Because of enhanced adherence to protocols of clinical trials and a lowering of human errors, thanks to automated tools of reporting such as digital equipment, there is less risk of incorrect entry of data and missing data.
Real-time report of data
Data tends to be accurate when it is recorded closer to the time of happening of events. The collection of data in real-time permits participants to report data when events are fresh in their memory.
In sum, DCTs are considered the final destination for the clinical trial industry because of the above reasons. The most important benefit is their capacity to put patients at the centre of a clinical trial without causing any disruption in their lives.