How the healthcare industry is conducting clinical trials is fundamentally changing and digital transformation is driving the change. In this post we dive into the impact of digital transformation on healthcare: key benefits, limitations, and real-world examples.
Digital Transformation & Healthcare
Digital transformation in healthcare means using modern technologies such as video consultations, mobile apps, electronic records, wearables, and remote monitoring to improve care and clinical research.
These tools speed communication, simplify data collection and expand patient access.
Traditional Centralised Clinical Trials in a Digital World
Traditional clinical trials are centralized, meaning they take place in specific hospitals or research centers. Participants must travel to these locations for tests, treatment, and follow-up visits. This allows researchers to watch participants closely and collect information in a controlled setting.
However, new digital technology now allows some study activities to happen outside the clinical trial site, such as in a person’s home or a nearby pharmacy. This change has led to what’s called decentralised clinical trials (DCTs).
What Is a Decentralised Clinical Trial (DCT)?
Decentralised clinical trials are studies where some or all trial activities take place away from traditional research sites, for example in participants’ homes, local hospitals, or community pharmacies.
The decentralised approach can help include people living in remote hard-to-reach countryside areas, small islands, or places far from major hospitals, as long as local healthcare support such as a pharmacy is available .
Technology in Decentralised trials
Medical researchers at Harvard Medical School report that decentralised trials allow people to take part from home or nearby healthcare services using new technology including:
- Telemedicine (video or phone doctor visits): Medical consultations are carried out remotely using video calls, telephone, or secure online systems.
- Mobile healthcare professionals: Nurses or clinicians who travel to a participant’s home during a decentralised clinical trial. They can collect samples, perform health checks, or give treatment at home. This is supported by portable medical equipment, digital monitoring tools, and secure communication system, allowing some clinical-trial activities to happen outside of the clinical site, making participation easier and reducing the need for travel while still keeping the study safe and reliable.
- Digital health technologies (DHTs): Connected devices such as smartwatches, glucose monitors, heart-rate sensors, or health apps that record health information continuously.
Differences Between Centralised and Decentralised Clinical Trials
Comparison Table : Traditional vs. Decentralised Clinical Trials
| Feature | Traditional Trials (Centralised) | Decentralized Clinical Trials (DCT) |
| Participant Location | Participants must travel to specific physical clinical sites. | Participants participate from home or local healthcare facilities. |
| Recruitment Reach | Geographically limited to the area surrounding the site. | Global/National reach; accessible to rural or remote populations. |
| Clear agreement | Paper-based, signed in-person at the clinical site. | Digital agreement forms via apps or portals with video support. |
| Data Collection | Dataset taken during scheduled in-person visits. | Continuous data from wearables, sensors, and mobile apps. |
| Participant Burden | High (Travel time, time off work, transportation costs). | Low (Integrated into daily routine, no travel required). |
| Regulatory Focus | Site-specific inspections and standardized local oversight. | Emphasis on data integrity across many locations and remote monitoring. |
Benefits of Decentralised Clinical Trials (DCT)
Convenience
Home visits, video or phone doctor appointments, and simple online agreement forms reduce the need to travel and make participation more comfortable. This can help more people stay in the study until the completion of the trial. If the patient must travel everyday to a clinical site attendance may decline as the trial progresses.
Diverse populations
Decentralised trials make it easier for people in remote areas, with rare diseases, or with mobility difficulties to join. This leads to more representative research results.
More efficient process
Remote recruitment and digital information collection can speed up enrolment, shorten study timelines, and reduce costs because fewer clinical site visits are needed.
Real-time monitoring
Wearable devices and apps allow continuous safety monitoring in real time, helping researchers respond quickly to health changes.
Limitations of Decentralised Clinical Trials (DCT)
There are some drawbacks to the decentralised approach.
Less direct oversight of participants
When participants of a clinical trial are not seen in person, researchers have less visual supervision. Tasks done at home or in different places may create inconsistent data unless clear instructions, training, and monitoring systems are used.
Technology access and digital skills
Not everyone has reliable internet, smartphones, or the skills needed to use digital health tools. This can make it harder for some older adults, low-income groups, or rural communities to take part, which may reduce fairness and diversity in research.
Data reliability and device accuracy
Wearable devices and home measurements may sometimes give inconsistent or inaccurate readings compared with hospital equipment. Researchers must therefore carefully check, validate, and monitor digital data to ensure study results remain trustworthy.
Regulatory challenges
Consistency in the regulations for decentralised clinical trials are not the same everywhere. In the United States for example, each state can have different laws about patient privacy and different licensing rules for doctors providing remote care. This means a doctor who is allowed to provide remote care in one state may not automatically be allowed in another state.
In the European Union, all member states follow the same main clinical trial laws, but how the rules are applied in practice can differ between countries, for example in approvals, inspections, or national procedures. Across the EU, the General Data Protection Regulation requires researchers to protect personal health data, collect only necessary information, store it securely, and clearly explain how it will be used.
Other international markets have their own national rules which further complicates the compliance picture.
What are the ethical considerations of DCT?
Decentralised trials must still protect participants by making sure they understand and freely agree to join, their personal health data stays private, and everyone has a fair chance to participate, even without strong digital skills or internet access.
Even when research happens remotely, the same basic principles of safety, fairness, and respect must always be followed.
Real-World Examples of DCT
WHO COVID Response
Global health researchers working with the World Health Organization report that decentralised and hybrid trials increased during the COVID-19 pandemic, when remote doctor visits, digital symptom tracking, and home delivery of medicines became necessary.
Pfizer’s fully decentralised trials
Pfizer conducted a remote clinical trial to study an over-the-counter treatment using a fully decentralised design. In this trial, participants were recruited online, received their study medication at home, and reported their outcomes digitally, without needing to visit a hospital.
The study demonstrated that remote participation and digital data collection can be conducted safely and effectively in real-world research settings.
Novartis DTC heart failure monitoring
Novartis has applied decentralised methods in studies focused on heart failure treatment and monitoring. Participants were monitored at home using wearable devices and had regular check-ins with healthcare professionals remotely.
Combining local healthcare visits with digital monitoring reduced the need for frequent hospital travel while still allowing researchers to track patient safety and treatment outcomes.
Conclusion
Decentralised clinical trials show how digital technology is transforming medical research. These trials can improve convenience, include more diverse participants, speed up studies, and allow real-time safety monitoring.
However, legal differences between countries, reduced direct supervision, and ethical responsibilities must be carefully managed.
References
European Commission, European Medicines Agency, & Heads of Medicines Agencies. (2023). Recommendation paper on decentralized elements in clinical trials. European Union.
European Medicines Agency. (2022). Facilitating decentralized clinical trials in the EU.
U.S. Food and Drug Administration. (2023). Decentralized clinical trials for drugs, biological products, and devices: Guidance for industry.
World Health Organization. (2021). Ethics and governance of artificial intelligence for health. WHO Press?
