Traditional clinical trials need patients to visit healthcare centers for appointments and tests. This can make it hard for patients who live far away or in rural areas to join. Decentralized clinical trials use technology to collect data and engage patients remotely. This reduces the need to travel.
In the United States, healthcare access differs a lot depending on the region and population. Decentralized trials help include more types of patients in research. This is important for creating treatments that work for everyone. Devices like wearables, electronic patient-reported outcomes (ePROs), and telemedicine help keep data steady while making it easier for patients.
Artificial intelligence (AI) agents have changed from simple automated tools to virtual helpers in clinical trials. Companies like Delve Health use many AI agents to send reminders, alerts, and nudges to keep patients involved and following the trial rules.
One big cause of delays in U.S. clinical trials is finding and keeping patients. About 80% of delays are related to this. AI agents help by handling tasks like scheduling, reminder calls, and solving problems. This personalized contact lowers the chance that patients will stop participating.
Delve Health’s Clinical StudyPal uses 32 AI agents to contact patients before they lose interest. The agents remind patients about their medicine, upcoming tests, or uploading data from wearables. This helps patients follow the rules well, with more than 90% sticking to the plan. Staying engaged is very important in long or complicated trials where many patients might stop.
A report from Delve Health shows AI agents also help reduce the workload on clinical staff by taking over many repetitive tasks. This lets healthcare workers focus more on direct patient care. Lowering this extra work helps trials run better and improves the quality of the study.
AI-powered virtual helpers watch how patients meet the trial’s rules in real time. They spot when patients might not be following steps and send alerts. This helps fix problems quickly. Trial sponsors get cleaner data, and patients get regular follow-ups without too much hassle.
For example, Medable’s eCOA+ platform uses AI to adjust questionnaires based on patient answers. It also gives real-time updates to clinical teams so they can act fast if needed. This keeps quality high during trials and avoids costly mistakes or missing data.
The United States has many different languages spoken besides English. When running decentralized clinical trials, offering support in multiple languages is very important.
Trial platforms that support many languages, like those from Delve Health and PPD, can talk in 65 to 100 languages. This helps remove language barriers and allows people from Hispanic, Asian, and other non-English-speaking communities to join trials.
PPD’s Patient First Contact Center provides ongoing multilingual help through live agents and AI tools. This kind of communication fits the culture of each patient, which helps patients feel comfortable and trust the process. These things are key to keeping patients involved and collecting good data.
Not understanding the trial or not having information in their language is a top reason why patients drop out. Giving personalized help in a patient’s native language helps them follow the rules and stay involved. Delve Health says their multilingual teams cut dropout rates a lot.
This is especially important for trials that reach out to rural or low-income areas where language can be a big barrier. Multilingual AI agents and human helpers allow trials to reach more places and types of people. This helps the study include a wider group of participants and improve following the rules.
One clear benefit of AI agents and multilingual support in decentralized trials is automating many tasks that used to be done by hand.
Staff members who run trials often spend a lot of time on scheduling, reminder calls, tracking data, and tech support. These tasks take time away from patient care. AI platforms handle notifications, appointments, and basic support through chatbots or virtual coordinators.
For example, PPD’s Virtual Study Coordinator automates patient contacts, sends protocol reminders, and helps with trial logistics. This cuts down staff workload, which is important for busy clinical sites in the United States.
Trials sometimes need to change their rules, called protocol amendments. Traditional ways to do this are slow and can delay the study. AI platforms like Delve Health’s Clinical StudyPal update these changes much faster, usually in days instead of weeks.
These platforms also connect easily with other systems like electronic data capture (EDC), labs, wearables, and eConsent tools. Capturing data directly from devices reduces mistakes and speeds up data availability. This makes the clinical trial data process better and helps meet regulatory rules.
Automated systems keep track of patient data submissions, how well patients follow the rules, and their engagement. Risk alert tools send immediate warnings about patients who might be at risk or missing data. This lets clinical teams in the U.S. step in quickly, making trials safer and data more accurate.
Using AI agents and multilingual support changes how decentralized clinical trials work in the U.S. They help patients stay involved and follow protocols better. These tools also improve trial results and expand access to new treatments for more people. For administrators and managers, adopting these technologies is an important step to making trials more efficient, responsive, and inclusive.
A decentralized clinical trial uses digital health technologies to enable remote patient participation, reducing or eliminating in-person visits. Tools like eConsent, ePROs, wearable devices, telemedicine, and digital engagement platforms facilitate these trials, making participation more accessible and convenient for patients across diverse locations.
Delve Health provides a unified DCT platform called Clinical StudyPal that integrates AI-powered pre-screening, multilingual eConsent and ePROs, FDA-grade wearable data collection, automated engagement through 32 AI agents, and human concierge services, supporting both hybrid and fully remote clinical trial models.
DCTs enable faster patient recruitment, broader geographic reach, increased retention through remote engagement, real-time data collection with wearables, reduced site burden and operational costs, and greater diversity and inclusion in trial populations, enhancing overall trial efficiency and outcomes.
Multilingual ePROs and AI agents communicating in over 65 languages help overcome language barriers, allowing underserved and globally diverse populations to participate. This personalized communication improves patient adherence, engagement, and retention by making interactions more accessible and culturally appropriate.
AI agents automate pre-screening, send personalized reminders, and deliver engagement nudges in real-time, reducing site workload and helping patients adhere to protocols. Their continuous interaction fosters higher retention rates and minimizes protocol deviations, ensuring high-quality data collection.
Real-time data, obtained through FDA-grade wearables and digital assessments, provides sponsors with continuous insights remotely. This accelerates decision-making by offering faster, cleaner, and more comprehensive data compared to traditional episodic collection methods, improving trial responsiveness and quality.
DCTs shift many repetitive tasks, such as reminder calls, scheduling, and tech support, from clinical sites to automated platforms. This reduces staff burnout, lowers operational overhead, and increases study efficiency by optimizing resource use and minimizing manual interventions.
Delve Health ensures regulatory-grade data security and compliance by being certified in ISO/IEC 27001, HITRUST CSF, and SOC 2. These certifications guarantee that patient data are protected, compliant with regulations, and accessible only to authorized parties.
Yes, DCTs are applicable across all phases from Phase I to Phase IV. Implementation strategies are customized based on the trial’s complexity, patient population, and regulatory requirements, making decentralized approaches versatile for various clinical research needs.
Often yes. DCTs reduce expenses related to site operations, monitoring, travel, missed visits, dropouts, and manual data management. This decreases overall costs while maintaining data quality and enhancing trial timelines, resulting in better return on investment for sponsors.
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