Virtual Trials in the COVID-19 Era

?Mater artium necessitas. ‘Necessity is the mother of invention.’

Across wide-ranging industries and lines of work the COVID-19 pandemic and its implications have had a tumultuous impact, on the one hand causing untold disruption and impediment, and on the other driving by necessity a rapid adoption of novel technologies. The Life Sciences and Healthcare industry is by no means exempt from this trend, and rather provides key insights into the dual effect of necessity and technological invention brought about by the coronavirus outbreak, especially around Clinical Trials. 

Clinical Trial Disruption

Before the COVID-19 pandemic, neither the ever-evolving drug development landscape nor the clinical trial industry were without difficulties and concerns; there have long been issues that require attention, in patient recruitment and retention, trial management, site engagement, and data capture, among others. However, the real disruption caused by SARS-CoV-2 has been the intensification of such problems and the urgent need for effective and long-lasting solutions in response.

Life Sciences SaaS company Medidata is continuously monitoring the impact on clinical trials of COVID-19 globally and in its most recent report (Release 9.0) from 21 September 2020 indicates a notable change in patient enrolment compared with 2019. In April, for instance, a 45 – 98% reduction in new patients entering clinical trials could be observed. Globally, most therapeutic areas experienced a downturn in August, including Oncology, with Cardiovascular seeing an improvement in August -20% compared to its pre-COVID baseline, whilst non-oncology therapeutic areas, the report highlights, are at -31% of the baseline.

A variety of causes for concern are examined by global data and technology company ERT in a report from June. Of these, the biggest issues clinical professionals identified as keeping them up at night in relation to running clinical trials during the COVID-19 pandemic are detailed in the image below.

Trial Virtualisation

Such disruptions, and the intrinsic necessity created by them, encourage, as the adage goes, ‘invention’; in this case one could argue that it takes the form of improvement, streamlining, and modernising of clinical trial design, conduct, and reporting. Virtual – or decentralised – trials are surely at the core of the paradigm shift. 

The aforementioned ERT report demonstrates that 33% of 114 sponsors/CROs surveyed were adopting virtual trial technologies prior to the pandemic, compared to 82% who state that their organisation is now doing so in response. Furthermore, 90% of participants responded that their organisation is somewhere along the continuum of virtual trial implementation. 

In addition to this increasing drive for virtualisation, or decentralisation, of trials, the benefits of these trials are widely acknowledged and appreciated, extending to patient recruitment, engagement, retention, and data collection with positive effects on trial duration and costs. A primary benefit to virtual trials commonly cited in the industry is their 'patient-centric' nature, eliminating the need for travel and arguably making the experience more comfortable for participants, who remain in their own home.

As BMJ notes, though COVID-19 may have resulted in ‘the greatest disruption to clinical research since the Second World War, the widespread implementation of virtual trial designs may mitigate some of the significant challenges ahead.’

Indeed, many in the industry are embracing some of the unexpected opportunities for innovation in the time of the ‘new normal’ and deem the digital transformation of clinical research an indispensable phenomenon which was always destined to happen, albeit at a slower pace; the global pandemic has accelerated progress and spurred innovation.

Do you agree? Has the crisis brought about opportunity for development and improvement in your experience and, if so, how has that been embraced?