Digital technology has influenced our life greatly in this 21st century. This revolution began somewhere in the mid-20th century and as of today it has revolutionized various aspects of our life. It is therefore no surprise that the healthcare sector is one of the beneficiaries of this digital revolution. In the simplest terms, electronic tools, devices that are capable of storing, processing and transmitting information are the digital tools used in the healthcare sector. Apart from the day-to-day clinical use, these digital tools are widely used in clinical trials. Thus, the term “digital clinical trial” refers to the use of digital technology to improve the patient and sponsor experience in clinical trials. These digital tools can be employed for end-to-end clinical trials or also as << hybrid models>> with digital technology integrated for a few steps during the clinical trial. Digital technology is available with a device that can allow remote access for patients as well as to the study investigators. This in turn helps to improve participant access, engagement, trial-related metrics, and/or interventions, allow for concealed randomized intervention allocation, and have the potential to alter clinical trials while lowering costs with optimizing timelines.
Digital technologies in clinical trials refer to various electronic tools and platforms that are used to enhance and streamline the process of conducting clinical trials. These technologies include electronic data capture systems, wearable devices by the study participants and sensors, telemedicine platforms, blockchain technology, artificial intelligence and machine learning algorithms, virtual reality and augmented reality applications, and more. They are employed to improve data collection, patient engagement, trial management, and overall efficiency in the clinical trial process.
Every phase of a standardized clinical trial is used by technology in a digital clinical trial. Digitalizing clinical trials is a potential and sophisticated approach to addressing current issues in traditional clinical trials. The National Institutes of Health and the National Science Foundation in the United States have expressed interest in digital clinical trials because they minimize costs and burden while providing a positive experience for participants and the research team.
There is now a chance to use digital technologies to accelerate the knowledge gathered from traditional clinical studies. By empowering and benefiting investigators and trial teams, digital technology can improve the productivity of clinical trials. A clinical trial can be conducted without an in-patient stay.
The features of digital clinical trials hold right from study design to study conclusion.
- Digital recruitment and retention
- Social media engagement (based on country-specific regulations)
- Online consent (based on country-specific regulations)
- Bidirectional communication
- Diversity in recruitment
- Ethical approvals
- Digital health data collection
- Patient-reported outcomes
- Ecological snapshot
- Digital biomarkers
- Wearable and mobile sensor technologies
- Data privacy
- Digital analytics
- Real-world data
- Interoperability
- Machine learning
- Artificial intelligence
- Precision studies
- Targeted interventions
One must collect data as part of the study procedure when we recruit volunteers for a clinical trial. Clinical trial digital data could be:
- Clinical and demographic data
- Captured physiologic and activity data
- E -medical records
- Pictures or videos from smartphones
- Patient-reported outcomes
- Corporal samples
To summarize, digital trials are altering the face of clinical trials by allowing trials to be handled efficiently and effectively with minimal resources in order to ensure cost-effective and timely completion of clinical studies. Even authorities such as the FDA, EMA, and Health Canada are encouraging sponsors to digitize their clinical trials by giving numerous advice documents for the use of digital technologies to conduct clinical studies.
