Part Two of The Decentralized Trials Series 

Our world is more accessible now than ever. Ever-evolving technological advancements allow us access to long-distance communication, education, and clinical evaluation. While these changes are exciting for some, they can be intimidating for those less familiar with the digital world. In the past, we have discussed decentralized trials and the benefits they provide both clinicians and patients. But what does the process look like in action? Here is a breakdown of the patient’s journey after they agree to participate in a decentralized trial using ePRO:  

  • A clinician will enroll the patient in the ePRO part of the study.  
  • The patient will receive an email containing a username and password which can then be used to access Prelude EDC for a quick link to download the ePRO app from the Google Play or Apple App Store. 
  • Once installed, a patient logs in with three pieces of information – study id, username, and password.  
  • After logging into the ePRO app, a patient will see any currently scheduled surveys, as well as any available surveys (e.g., a survey to report an adverse event). 
  • If desired by the study, patients can log into Prelude EDC via a browser and edit surveys that were previously completed. 
  • Patients will receive push notifications (if enabled) to fill out the survey – until the survey expires or is completed. Surveys provide a multitude of data entry options, including (with examples) … 
    • Dates & times – When did the adverse event occur? 
    • Text – Describe your symptoms. 
    • Numbers – Enter your temperature. 
    • Radio options – Did you take your medication today? Yes/No 
    • Visual analog scales – What is your current quality of life (Very Poor to Very Good)? 
    • Photos – Include a photo of the stool. 
    • Videos – Submit a video of muscle spasms.  

Voilà! It really is that simple. Now the patient can use ePRO confidently from start to end of a clinical trial. They can report on their quality of life, adverse events, symptoms, or even benefits they notice throughout the trial from their phone – and without frequent trips to a clinic. They can participate in life-changing studies from the comfort of their own homes. 

The benefits of decentralized trials do not stop with humans. This process can be translated to animal health as well! Through the ePRO app, patients can submit surveys regarding their furry friend’s health and wellbeing. Pet owners can receive push notifications to remind them to fill out essential information, including photos and videos, to ensure compliance. We know that pets cannot fill out surveys (or talk – even though my 2-year-old cousin wishes they could), so our system was designed with pet owners’ preferences in mind. As the developers of Prelude EDC, the #1 EDC software system in Animal Health, Prelude Dynamics has made sure that animal owners and human patients involved in clinical trials will benefit from this new streamlined process. Unnecessary visits to the clinic can become a tribulation of the past.  

Look out for follow-ups in our series, including options for partially decentralized trials. 

Want to learn more about our Decentralization tools? Contact Us.