More than 1,200 clinical trials featuring a decentralized or virtual component took place in 2022 –– a 28% increase from a year earlier.
Though some trial sites are returning to in-person setups, a recent report from Clinical Trials Arena suggests decentralization is here to stay. And, while that presents exciting opportunities, the lack of human oversight can present potentially serious risks.
Remote data collection technologies via smart phone apps and wearable devices make it easy to collect and record data, but these tools only go so far. A team of qualified human research professionals can ensure consistency and integrity and provide peace of mind.
Decentralized Clinical Trials: Why Human Intervention Matters
Many clinical trial participants are also members of vulnerable populations, including people with:
- Neurodegenerative illnesses, such as Alzheimer’s disease and other types of dementia
- Nervous system disorders that affect mobility and independence, such as Parkinson’s disease and multiple sclerosis
- Speech or communications challenges, such as stroke survivors
The symptoms associated with these and other serious health problems can make it difficult to collect data remotely through smartphone Apps or wearable devices. That’s why it’s essential to include a human component in your strategy in most cases.
For example, many biopharmas are turning to mobile research nurses. These nurses visit trial participants at home, set up the technology and explain how to use wearable technologies and regularly check in to ensure they are being used properly.
Coordinating in-person checkups takes extra time and effort, but it keeps the patient engaged in the trial while increasing the accuracy and reliability of the collected data.
Human Oversight: Improving Protocol Compliance and Trial Accuracy
Wearable devices, such as smartwatches and glucose meters, are designed for accuracy and precision. But, like any technology, they are not 100% reliable; Batteries die, wires short-circuit, and sensors malfunction.
And what about human error? Since decentralized trials rarely include in-person checkups, many patients forget to charge their devices or wear them altogether.
Once again, we’re reminded of the human factor. Having a team of qualified mobile nurses or mobile research professionals can serve as your eyes and ears. They can help you spot potential problems and ensure patients are adhering to the trial protocol.
Combat Decentralized Trial Complexity with Qualified Monitoring Experts
Over the last few years, we’ve seen a large increase in the number of decentralized and remote clinical trials.
Though incredibly convenient and often essential for the patient, medical procedures, such as blood draws, drug infusions, and diagnostic imaging require additional coordination for completion.
Remote trial nurses or trial monitors can coordinate laboratory services and other in-person checkups. They can identify patient misunderstandings or noncompliance, make the necessary corrections, and keep your study on track. For those procedures that must be done in clinics, transportation service providers are also a key part of ensuring trial compliance.
Automation is an amazing tool, but it doesn’t replace the need for human involvement altogether. To succeed in today’s decentralized environment, complementing technology with a human touch is essential.
Get Things Done… FAST
Is your team preparing to launch a decentralized clinical trial in the coming months? If so, let us help you maximize efficiency, quality, and value with our Functionally Aligned Strategic Team (FAST).
Our FAST team acts as an extension of your brand by:
- Providing quality control services
- Implementing an inspector readiness plan
- Drafting trial protocols
- Updating the Investigator Brochure
- Establishing a governance structure
Working together, we can keep patients healthy and happy and ensure your study stays on track.
To learn more, click here or call (781) 775-0342.