FDA Decentralized Trials and Digital Health Technologies - A New Era in Clinical Research
While many DHTs have been around for years, recent advancements have been game-changers for decentralized models, which can't rely on traditional research facilities or specialists for data collection
Last year, the Food and Drug Administration (FDA) released a draft guidance on how to carry out decentralized clinical trials (DCT), the first set of standardized protocols for DCT adoption. The pandemic accelerated the move to decentralization, but luckily, advancements in digital health technologies (DHT) have made that transition possible.
Today, we're exploring digital health technologies, their evolution and benefits, and their critical role in facilitating decentralized clinical research.
TABLE OF CONTENTS
- What Are Digital Health Technologies?
- How Have DHTs Evolved in Clinical Research?
- DCTs and DHTs: A Match Made in Heaven
- Common Challenges With DHTs and DCT
- How Does the FDA Fit In?
- The Future of DHTs and DCTs
- Keep Up With the Latest in Clinical Research With StudyPages
What Are Digital Health Technologies?
Digital health technology is any system or device that can directly monitor or capture health information. Examples include:
- Mobile and telehealth systems
- Wearable and implantable devices
- Ingestible sensors
- Interactive mobile applications
While many DHTs have been around for years, recent advancements have been game-changers for decentralized trials, which can't rely on traditional research facilities or specialists for data collection.
How Have DHTs Evolved in Clinical Research?
Before they evolved into more advanced devices, DHTs were initially simple tracking tools such as step counters and heart rate monitors. Now, there are additional innovations: for example, an accelerometer, is a tiny chip in phones and smart watches that can detect motor function, exercise patterns, and many other discrete events and movements, such as:
- ECG
- Pulse
- Breath
- Coughs
- Seizures
- Tremors
- Blood oxygen
- Glucose levels
- Blood pressure
Today, digital health devices perform complex tasks like measuring speech and tracking cognition. Researchers have also been using DHTs in neurological trials for various diseases, including epilepsy, multiple sclerosis, and Parkinson's.
DCTs and DHTs: A Match Made in Heaven
The advancement of DHTs has complemented the rise of decentralized clinical trials perfectly.
As technologies get more accurate, reliable, and secure, they become easier to leverage in decentralized research models, resulting in multiple benefits:
Creating a patient-centric design
Decentralized trials put patient needs first by making the process more convenient. With DHTs, researchers won't require patients to regularly visit for checkups or observations, effectively making the home a decentralized research space.
Improving recruitment and retention
Decentralization will also improve patient recruitment and retention as DHTs dramatically reduce the burden of participation.
Increasing diversity and inclusion
Another key advantage to DHTs is they can be accessed and used by anyone, including social minorities and those in rural areas. Given that a lack of diversity can spell trouble for clinical trials, DHTs represent a significant boon to the DCT research model.
Reducing costs and saving time
Finally, using digital health technologies in decentralized trials is more cost-effective and, in some cases, can have up to a seven-fold return on investment.
Common Challenges With DHTs and DCTs
On the flip side, DCTs and the DHTs that facilitate them also pose challenges researchers must recognize and overcome:
- Keeping electronic information private and secure
- Ensuring data reliability through participant authentication
- Training staff and participants on how to use new technologies
- Managing data from multiple sources, sites, and systems
How Does the FDA Fit In?
The FDA is also doing its part in guiding clinical trial decentralization. Besides releasing the first-ever draft guidance on DCTs last year, they've created a framework that includes additional resources to help stakeholders tackle the unique challenges of implementing DCTs on a larger scale.
The Future of DHTs and DCTs
The future of clinical trials will likely rely on a hybrid model, combining digital health technologies and remote monitoring with traditional site visits.
However, the possibility of fully decentralized trials isn't that far-fetched, and we've already begun to address the challenges decentralization poses with new technological solutions:
Edge computing
Typically, DHTs send the patient data they collect to a central server for processing and analysis. With edge computing, data is processed immediately by the device that collects it, such as a smartwatch.
Zero-trust environments
The zero-trust environment in decentralized clinical trials means the system never trusts any user. To address security issues and challenges with authentication, users must verify their identity and permissions every time they access any part of the network.
Federated computing
In a decentralized clinical trial model, federated computing allows different organizations associated with the study (such as research centers or hospitals) to share information without making their data accessible to outside parties. This new approach directly assesses the issues of managing data from multiple sources and systems.
Blockchain
Blockchain is another technology researchers and trial designers hope to leverage to enhance trust and security in DCTs. Since the blockchain is impossible to manipulate, it addresses many data security and integrity issues.
Artificial intelligence (AI)
Artificial intelligence represents the cutting edge of digital health technologies in decentralized trials. AI algorithms help analyze vast amounts of data to develop predictive models, identify suitable candidates, optimize protocols, and monitor data remotely.
Keep Up With the Latest in Clinical Research With StudyPages
The growing popularity of decentralized trials is largely due to the continued advancement of technology, creating an exciting prospect for the future of medical research.
Today, investigators use digital health technologies that weren't available five years ago. Imagine what the next five years will bring.
With StudyPages, you can keep up with all the latest clinical trial news and be the first to learn how new health technologies are impacting medicine.
You can also request a demo to see how StudyPages' clinical trial management software can help streamline your next decentralized study.