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Decentralized Clinical Trials: Everything You Need to Know

10 Mar, 21 | illumisoftadmin

The pandemic has forced us to reimagine the way we do things. Not just on a basic level such as grocery delivery, but even things like doctor visits. This shift has forced us to adopt innovative ideas and practices quickly, spurring massive development of technology. 

While evident in many industries, healthcare has seen extensive utilization of technology that, up to this point, has been moving at a snail’s pace– nowhere more so than in clinical research studies, where decentralized clinical trials are quickly becoming the norm.

What is a Decentralized Clinical Trial?

In short, a decentralized medical trial, otherwise known as virtual, home, remote, or siteless trials, are studies that minimize the physical contact patients have with healthcare professionals through the use of new technologies. The FDA also defines this as the decentralization of clinical trial operations where different technology is used to transfer information with participants and collect various types of data.These trials play a significant role in the product development process, especially in today’s world where doing things remotely has now become not just the new norm, but a way of life. 

How it Works

A decentralized medical trial is usually conducted with the utilization of a wearable sensor device that can relay information directly to electronic patient diaries, removing the need for patients and staff to register data. This information is then translated to eHealth and eCOA records for physicians to review.

Rather than have patients come into a medical center several times per week or month, almost all data can be gathered from a distance, removing the need for travel by patients. Instead, healthcare staff will go to patients to deliver drugs or take vital readings, while all routine tasks are handled using technology. Overall, this is a much more patient-centric approach but saves time and effort for everyone involved. 

Benefits of Decentralized Clinical Trials

Remote trials break through some of the biggest barriers that often prevent traditional clinical trials from gaining the information they sought. The major benefits include: 

    • Increased participation– By eliminating the availability issue, decentralized clinical trials become more accessible and allow almost anyone to participate.
    • Wider range of patients With no added travel costs, it opens up the opportunity for a bigger pool and also increases diversity. This leads to more patient data sets yielding more well-rounded results. 
    • Real-time results– Because all data is collected digitally and in real-time, this means results are available immediately allowing researchers to monitor patients around the clock rather than a few times per week.
    • Improved data– In-person appointments and manually filled-out forms leave room for error. By relying heavily on remote patient monitoring systems (RPM) the data is accrued immediately. This automated process ensures physicians and patients don’t miss pertinent information. 
    • Faster analysis– With real-time, accurate results and 24/7 monitoring analysis of results can be executed more quickly.
    • Lower Costs By increasing participation the cost of recruiting patients naturally decreases resulting in cost savings of up to $36,000. 

Barriers to Overcome

The healthcare industry is quickly adopting new, innovative, and arguably more efficient methods for research and patient care. In fact, according to a recent study, 76% of industry respondents are taking advantage of decentralized clinical trials. However, there are hurdles to be prepared for.

  • Data volume- The amount of data coming in can easily overwhelm existing systems.
  • Data harmonization- Data from different devices is not always synergized and must be manually formatted. 
  • Chain of custody- A lack of security threatens to ensure patient confidentiality. It must be shared between patients and staff only.
  • Reliability- Devices used can fall short of ensuring data reliability and quality by not collecting what’s needed. 
  • Patient engagement– Having direct access to the data through wearable devices or RPM decreases the need to interact with patients as regularly which can ultimately cause a disconnect between researchers and patients. 

Ensuring Success with Customized Software

With a smart cloud-based solution organizations can easily handle the volumes of accruing data while harmonizing different types of data sets and ensuring accuracy. However, different organizations have different needs– taking a one-size-fits-all approach when choosing software is not likely to yield a successful clinical trial. This is where illumisoft comes in.

illumisoft is a custom software development company specializing in healthcare solutions. Expert developers create simple data automation and management that will be fully integrated into current processes and act as a guide during its implementation. 

Mitigating the challenges of decentralized clinical trials can be a multi-faceted endeavor when addressing each barrier directly. Or, it can be a holistic approach with tailor-made software.