Decentralized trials, also known as virtual clinical trials (VCT), Patient-centric, remote, site less, hybrid, or digital trials. These trials use technology, such as wearables and telemedicine (apps, electronically monitoring devices, etc.) and online social engagement platforms, to collect data from patients outside of a traditional clinical setting. With this article, Clinichain would like to inform you by sharing our experience and insights we have seen for the last years within devices and technology for these type of trials and the challenges that come with these needs.
According to the FDA, decentralized clinical trials (DCTs) are defined by “the decentralization of clinical trial operations where technology is used to communicate with study participants and collect data.”
How your study can benefit from decentralized trials
-Increased patient convenience and accessibility
-Lower costs compared to traditional trials
-Faster recruitment and data collection
-Ability to reach a wider patient population
Most used Wearables and clinical equipment for studies
Wearable devices play a significant role in clinical trials, varying based on the type of study and its objectives. Some of the most popular wearable devices used in clinical trials include:
-Smartwatches like Apple, Bio-beat and Garmin Watch, which can collect data on heart rate, sleep, steps, and more. These wearables are popular in clinical trials focused on prevention and health promotion.
-Fitness trackers like Fitbits which collect data on activity, sleep, heart rate, and energy balance. These wearables are popular in clinical trials aimed at improving physical fitness.
-Medical wearables such as ECG sensors, which collect data on heart and vascular diseases. These wearables are popular in clinical trials aimed at diagnosing and treating heart and vascular diseases.
-Wearables focused on specific diseases, such as smart inhalers for asthma patients or sensor-based devices for diabetics.
-Portable equipment like; traditional ECG’s, Centrifuges, oximeters and infusion pumps are also common used equipment for home nurses
Challenges when connecting wearables to external software for clinical studies:
-Compatibility: Some wearables are not compatible with certain software or systems, making it difficult to share and integrate data.
-Data format: Different wearables collect data in different formats and with different accuracy, making it difficult to combine and analyze the data.
-Data privacy and security: Wearables often collect sensitive patient information, such as health data, which raises concerns about protecting this data from unauthorized access or misuse.
-Regulation: There are specific regulations for the use of wearables in clinical trials, such as FDA regulations in the US, which can influence the development of the software.
-Battery life: Many wearables have limited battery life, requiring frequent charging or causing patients to not wear the device, leading to no data collection.
-Ease of use: Some wearables are complex to use, causing patients to not be able to use them correctly and data to not be collected correctly.
-Global logistics, making sure import and export paperwork is handled the right way
-Local sourcing of equipment can be challenging and Regulatory challenges
Despite these challenges, more and more research are being conducted to resolve these issues and more we see standardization methods are being used to integrate wearable data into clinical trials.
Leading Countries using decentralized trial equipment
Decentralized trials, are becoming more widely conducted globally. Leading countries in the implementation of decentralized trials include:
-United States: In the US, there are several companies and organizations conducting these trials, especially in the areas of digital health and pharmaceutical industry.
-Europe: In Europe, several countries are actively engaged in conducting decentralized trials, particularly in Germany, the United Kingdom, and Sweden.
-Canada: Canada is one of the leading countries in implementing decentralized trials, particularly in the province of Quebec.
-Australia: There is increasing interest in conducting decentralized trials in Australia, especially in the metropolitan areas of Sydney and Melbourne.
-Other countries where decentralized trials are gaining traction such as South Korea, China, Japan, and India.
Decentralized trials are becoming increasingly popular worldwide, as they offer many benefits over traditional clinical trials. However, there are still challenges that need to be addressed, such as sourcing suitable devices and the global logistics with compatibility and the right data management integration. Despite these challenges, the future looks bright for decentralized trials as they continue to revolutionize the way clinical research is conducted.
Are you expecting a hybrid or decentralized trials where you need any type of connected device or rental equipment for your studies? Contact us to see how we can help you every step of the way.