The Future of Clinical Trials: Embracing Wearables and Beyond

As the world moves forward, the clamor for more efficient, accurate, and patient-friendly trials grows louder. Wearable devices could be the answer to this call. But are we ready to embrace them fully? With Sponsors becoming increasingly wary of Decentralized Trials, how will this impact wearables and sensors? This article will outline the importance of continued innovation through clinical trial technology and the benefits you and your patients can gain. 

The Current Hesitance Towards Wearables

Despite their potential, wearables have yet to achieve universal acceptance in clinical trials. A few reasons for this hesitation include:

1. Data Security Concerns: There’s apprehension about the safety of patient data collected through wearables. As per a report from the Pew Research Center, 79% of people are concerned about how their data is being used by companies.
2. Reliability of Data: Some critics question the accuracy of data from wearables. A study by Stanford Medicine found that while wearables are fairly accurate for measuring heart rate, calorie burn estimations can be off by a significant margin.
   

The Inevitable Need for Wearables in the Future

Despite the current reservations, it’s hard to deny the looming necessity of wearables in clinical trials:

1. Surging Trial Volume: As diseases become more complex and varied, the number of clinical trials and their scale is bound to increase. Wearables can handle this upsurge by facilitating continuous, remote monitoring.
2. Rising Endpoint Requirements: With more endpoints to monitor, traditional methods might soon become cumbersome. Wearables, with their ability to track multiple metrics simultaneously, are a natural solution. According to ClinicalTrials.gov, the average number of trial endpoints has risen by 20% in the past decade.
   

Why We Should Champion Wearables Sooner Rather Than Later

1. Enhanced Patient Experience: Wearables can drastically reduce the need for frequent hospital visits, making the trial process less intimidating and more accessible.
2. Cost Efficiency: A study by mHealth Intelligence suggests that wearables could cut down clinical trial costs by up to 60%, mainly by reducing the need for physical infrastructure and streamlining data collection.
3. Real-time Monitoring: Continuous data collection means anomalies can be detected and addressed almost immediately, potentially increasing the trial’s overall success rate.
   

The Continued Relevance of eCOA/ePRO

While wearables are game-changers, tools like eCOA (Electronic Clinical Outcome Assessments) and ePRO (Electronic Patient-Reported Outcomes) remain vital. They offer a structured way to collect subjective data directly from patients, ensuring their experiences and symptoms are captured accurately.

However, post-COVID, there’s been a noticeable trend: sponsors are gravitating back to simpler trial designs, perhaps reacting to the complexities the pandemic introduced.

Why Going “Back to Basics” Might Be Short-Sighted

It’s understandable that, after facing challenges with decentralized clinical trial (DCT) providers, some sponsors might be wary. But completely discarding the concept because of past hiccups isn’t the solution.

Here’s why:

• Hybrid Models are the Future: A complete shift to DCT might seem daunting, but a hybrid model – blending traditional and modern methods – can offer the best of both worlds.
• eConsent and Telehealth: These tools are indispensable in today’s digital age. eConsent ensures informed patient participation, while telehealth can bridge the gap when in-person visits aren’t feasible.
  

The Importance of Not Alienating Sites

While digital transformation is vital, clinical sites remain crucial. They offer expertise, infrastructure, and the human touch that technology can’t replicate. The key is to integrate new tools without sidelining these sites, ensuring a harmonious and effective collaboration.

In Conclusion

The future of clinical trials is promising and brimming with potential. Embracing wearables and other digital tools can revolutionize how we conduct these trials. However, it’s essential to remember the value of traditional methods and strike a balance. After all, in the quest for medical advancement, every tool, old or new, has a role to play. Learn how Datacubed can help you innovate with a safe pair of hands.