Wearable Biosensors - Decentralized and Hybrid Clinical Trials

With physiological wearable biosensors now widespread consumer products and living in  a post-COVID-19 world there is a rapid shift away from traditional centralized clinical trials and towards decentralized clinical trials (DCTs) and hybrid clinical trials (HCTs).

 

In DCTs and HCTs technologies are used to monitor the patient in the form of wearable biosensors or point of care invitro-diagnostics. The key requirement is that these technologies are operable by the patient and connected to the Cloud so that the patient data can securely send data to the Cloud enabling the patient's clinical status to  be remotely monitored.

 

In traditional clinical trials patients may be expected to either be resident at or to regularly visit a centralised clinical centres, but in these next generation of studies the patient remains within their community, and so their is a shift towards patient centric studies;  is an evolution in the adoption of pre-existing technologies rather than a revolution in technology.

 

Today many of the point of care IVDS or wearable biosensors required for DCTS and HCTS  already exist, though the critical internet connectivity maybe lacking. As ZP we Cloud enabling wearable biosensors and IVDs so they can be used in decentralised clinical  trials.


What are HCTs and DCTs?

DCTs and HCTS are virtual studies where the interaction between the clinical trial coordinators and the patients can be much  more direct, with a  reduced reliance on patients visiting clinical research centres. In DCTs the patient monitoring may be 100 % decentralized, whilst in the HCTS there maybe some visits to a centre for check ups, but with a majority of the data coming into the study through remote monitoring.

Remote clinical trials.

As employment has become remote, semi-remote and hybrid with people working partly in the office and partly at home during the SARS-CoV-2 pandemic  it was inevitable that clinical trials should also follow the same  paths.

The benefits of HCTs and DCTs.

The benefits of HCTs and DCTs includes: 

 

  1. Adaptability to schedules
  2. Increase patient's convenience
  3. Possibility to access a broader patient population
  4. Reduced costs with regard to fixed trial sites
  5. Increased compliance with the FDA sentiment of ' safely is critical'

Some of the perceived concerns of HCTs and DCTs are overcome when working with ZP, this includes:

 

  1. ZP identifying or enabling biosensor technologies with Cloud connectivity 
  2. ZP gather of biosensors or IVD data in their proprietary Cloud - Djuli
  3. A pre-existing workflow for remotely gathering biosensor and IVD data

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