24/08/2020

Covid-19 and “virtual” Clinical Trials

The effect of the pandemic was alarmingly immediate on clinical trials. Many trials experienced delays or were put on pause as hospitals that serve as trial sites were overwhelmed with COVID-19 patients and were no longer available. The number of disrupted clinical trials has continued to grow over the last three months, with suspension of enrolment accounting for 61.5% of the disruptions.

This has led to an increasing push towards virtual trials or at least elements of virtual trials that are now more likely to come to the forefront faster than they otherwise would have done due to the pandemic. In its most extreme form, a virtual trial has the potential to completely separate patients from direct contact with a trial site or provider, and where patient recruitment, consent and data collection are all conducted virtually. This could immediately help trials that are being met with patient quarantine and travel limitations, clinical site closures and interrupted supply chains.

Many obstacles have hindered the popularity of virtual clinical trials: lack of data integration and unclear regulatory acceptance being the major ones stopping pharma companies and CROs from incorporating virtual components into their trials. 

This is where the implementation of ClinTex CTi arguably has its strongest use case. It has the potential to aggregate data coming from clinical sites, investigators and patients in a secure, transparent and auditable manner that allow for effective analysis and alleviates pressures to follow procedures, document things correctly and any medical dispensing errors. The full potential of CTi in supporting this new normal is extensive and outlined in the figure below.

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Furthermore, in the midst of a global pandemic, pharma regulators (who have arguably been slow to accept technology adoption in the past) are now more than ever likely to acknowledge the need for change and acceptance of digital endpoints in clinical trials. The Dutch government is a great example of senior political leadership now working to deploy a blockchain-based solution to ensure transparency across the medical supply chain in the fight against COVID-19.