Veeva Systems recently carried out its Digital Clinical Trials Survey report which found that 87% of companies are now using decentralised technology up from 59% pre-pandemic. Companies have added an average of four new applications to their clinical landscape since the start of the pandemic leading to increased challenges with fragmented systems and processes. The research also found that clinical leaders are expanding their study models beyond decentralisation. Many sponsors and CROs are moving to establish a connected clinical ecosystem that improves collaboration with research sites, drives better patient engagement and allows seamless data sharing across stakeholders.

Virtual Clinical Trials are Accelerating

It’s clear to see that digital transformation of clinical trials and research is accelerating rapidly and offers sponsors numerous advantages from efficiency and cost effectiveness to improved patient compliance and datasets that capture a broader population. Yet there are legal concerns that there are still lots of regulatory and logistical hurdles to overcome. 

There are concerns and expectations across the life science industry that guidance and regulations must be adapted to fit this new reality. A key concern raised is how to ensure adequate investigator oversight of the trial when part of, or the entire, trial occurs remotely from the investigator site. Another significant challenge lies in ensuring patient privacy when implementing new technology to transfer data from the patient.

Many of the regulatory challenges are dependent on whether the trial is fully DCT, or whether many of the concerns and challenges can be off-set through a hybrid model of DCT. Fully DCT, patients/subjects remain remote from site visits and therefore no physical visits are conducted at a clinic, but this means that a wider group can be reached to be trial participants and should only be used for specific applications. However, this model can create more regulatory concerns if the monitoring of the patient and/or types of patient means that they must be on-site and seen by investigators in person at certain end points during the trial. Hybrid models of DCT can be either a fixed or a flexible hybrid model where certain site visits can be arranged for certain invasive/non-invasive tests.

While virtual clinical trials were being explored long before the pandemic, they have accelerated since the pandemic, and everyday more steps are being taken to implement the virtual clinical trials as part of regular clinical trial practice. Industry associations, regulatory authorities, sponsors and CROs are gaining valuable insight into the benefits of a new way of working, which will significantly change the way clinical trials are carried out in the future.