Many pharmaceutical companies are turning to decentralized clinical trials (DCTs) as their strategic priority, especially after the onset of the COVID-19 pandemic. Unlike traditional trials, DCTs are conducted remotely or through local health centers for improved patient experience.
Through the use of DCT solutions, some unmet needs in the conventional setup can be satisfied without involving patients. For this, clinical trials utilize various digital technologies, including wearable medical devices, sensory-based devices, and such approaches as telemedicine and home visits for recruitment and follow-up.
Here are the advantages of DCTs over traditional trials.
Flexibility
Any traditional clinical trial involving the life sciences is conducted within the immediate vicinity of the research center. This is because the monitoring team will be able to interact with participants and collect data within the control. Participants are sometimes required to travel to therapeutic areas for data collection, which may disrupt their daily activities.
However, DCT solutions employ a patient-centered approach where wearable technology plays a major role. Therefore, patients can participate remotely and the study is more flexible as it allows data submission to be made anywhere around the world.
Better Patient Recruitment and Easier Retention
DCT can improve participant recruitment and retention for each study. In a traditional setup, it is believed that about 30% of the participants recruited for the study drop out before the end of the trial period. This is because of the disruption to their work and other barriers to the execution of the trial objectives.
Decentralized trials have successfully employed mechanisms to keep the participants of specific studies positively engaged and motivated throughout the study. Research team members understand and emphasize the patient experience throughout the study. Second, there is no significant burden, lowering the likelihood of attrition and increasing client retention.
There are fewer site visits, fewer in-person interactions, and stricter patient safety while enhancing patient engagement. All of these factors make the study more of an opportunity for the patient than a burden.
There is Enhanced Data Diversity
Decentralized studies can be effective in reducing geographical barriers to reaching a diverse population, including the elderly, adults, and minorities who live in different environments. Researchers will not be moving around as much, and clinical trial sponsors will have a richer population and more diverse patients.
Digital health technologies are used over a wide area, allowing sponsors to improve data quality and increase the validity of the trial. This is because different groups and geographical settings have an effect on specific variables, which in turn, enables better decision-making.
There is Real-Time Communication with Patients
Effective communication between the participants of a study and the researchers is vital for the investigation to move as required, keep patients motivated and enhance retention. DCT solutions include real-time communication tools that allow participants to submit data as soon as they get it.
These data can include new symptoms, automatic readings from wearable technology, and virtual visits with researchers to discuss the information. Additionally, telemedicine makes it easier for clinical researchers to interact with participants whenever there is an opportunity, thereby facilitating the eventual completion of the study.
Financial Benefits
DCT makes clinical studies cheaper than traditional and hybrid trials. A significant budget usually is allocated to monitoring and facilitating visits to research sites. This is eliminated and replaced with virtual trials. The team will not have to look for the participants or make appointments for them to keep visiting the sites.
The only significant costs in DCTs are the medical devices that are given to the participants. Most of these wearable devices can be reused in future trials, especially where they do not involve invasive techniques or contact with body fluids. This makes it easier for sponsors to conduct studies over a wide area and as often as needed.
Decentralized trials are the future of clinical studies. They offer several benefits to pharmaceutical companies, enabling them to conduct complex studies remotely. Today, they are common in pandemic studies, drug development, and evaluating the effects of specific drug administration exercises. Patients also experience less burden and no site visits during the study period. Sometimes, DCTs can be combined with traditional aspects of clinical research where personal attention is required, resulting in hybrid trials.
