Speculative article on decentralised trials in the COVID era.  Will they be here to stay or will the industry revert to pulling patients in for regular visits once we are all out of lockdown?


CONTEXT:  Looking at ‘remote’ solutions to address the challenges faced when you can’t visit a clinic or the number if patients is so low that the traditional method of setting up sites and following patients is impractical (e.g., rare and orphan diseases)  It’s a topic that’s gaining a lot of traction, it’s almost like the healthcare world is catching up with the IoT world…at last!! | Watch this space because DCTs are destined to become the next big thing in clinical research.


READ TIME:  3 mins

Quality Level Mean [1 – 10]:  5

1. “Credit: IQVIA[/caption] “The decentralized model works very well for a smaller patient population that might be spread across the world and cannot come to the sites, which is often the case for rare disease patients,” says IQVIA senior vice president and chief digital officer Nagaraja ‘Sri’ Srivatsan.” 

2. “Sensors and wearable tech can also make access to research a lot easier for rare disease patients through the use of watches, adhesive patches and other types of sensors that can be used to capture ongoing data about the patient’s daily activity – their sleep patterns, vital signs, posture and more.” 

3. “In rare diseases this risk factor is increased; with the patient group often very small, every data point is incredibly important.” 

4. ““In the case of having a home health nurse where typically we would see that it is the same nurse going to the patient’s home — our patients tend to create relationships with those nurses and it really fosters a connection to the research,” Arellano added.” 

5. ““Anticipating the future,” says Srivatsan, “once you put the infrastructure to engage the patient, there are lots of mechanisms you can put into the patients’ homes to start getting more and more rich data and information to engage them better and detect changes earlier.”” 

Source URL: https://www.clinicaltrialsarena.com/analysis/rare-disease-research-decentralised-trials/