Clinical Trials During COVID-19: Time to go Virtual

The ongoing COVID-19 pandemic has been nothing short of a nightmare. As the number of infected patients approaches 400,000, there is already a sense of worry looming across the industries. From disrupted supply chains to a prominent decrease in demand, the pharmaceutical industry is also facing its share of difficulties.

We, at Roots Analysis, have been trying to understand the extent of the impact that the virus is likely to have on the pharmaceutical industry. One of the areas that has been deeply impacted by COVID-19 is clinical research. A number of pharmaceutical companies have halted clinic studies in recent days.

An interesting article, published two days ago in Nature titled, Cancer drug trials on hold amid coronavirus disruption, presented a patient’s view on the impact of halted clinical trials due to COVID-19.

In order to minimize the impact of the COVID-19 on clinical trials, the US FDA has urged pharmaceutical companies to switch to virtual clinical trials.

What are Virtual Clinical Trials?

Virtual clinical trials represent a novel approach of collecting safety and efficacy data from clinical trial participants. In such designs, there is no need for the participants to travel to a clinical research site/facility or a doctor’s clinic. Such trials make use of software applications, monitoring devices, and online social engagement platforms to conduct each step of the clinical trial process, including recruitment, patient counseling, informed consent, measuring clinical endpoints and adverse reactions, as per the patients’ comfort. Although virtual trials still require the study site to accommodate support staff and invest resources in data gathering and analysis, these are significantly more cost-effective as they do not require traditional brick-and-mortar set-up of multiple investigation sites.

In addition, these trials enable elderly or patients living in far-off areas to participate in the trial, thus enabling the involvement of a highly diverse patient population. Such an arrangement offers opportunities for a more patient-centric approach as patients can participate in the trial as per their convenience and without worrying about the need to travel to the study sites. In addition, virtual trials enable researchers to capture and access data through remote monitoring devices in real-time; thus, improving trial designs that are based on accumulated data.

Virtual Clinical Trial

Adoption of Virtual Clinical Trials

In 2011, Pfizer pioneered the first-ever virtual research on electronic monitoring of the overactive bladder treatment experience (REMOTE) trial. It was the first randomized clinical trial that used web-based patient recruitment. In addition, the collection of study data was done without requiring patients to visit an actual study site. Since then, several other pharma giants including Amgen, GlaxoSmithKline, Janssen, Merck, Novartis, and Sanofi have utilized virtual clinical trial technologies. In a detailed social media analysis, we were able to identify close to 3,000 tweets referring to virtual clinical trials.

Social Media Activity on Virtual Clinical Trials

Recently, Catalyst Pharmaceuticals reported to Reuters that it was implementing a virtual approach with doctors and company representatives. More importantly, the company remained on track to report results from its ongoing late-stage trial in the second quarter.

Virtual Trial Service Providers

Over the years, several virtual clinical trial service providers have entered the market. These players are collaborating with drug/therapy developers, in order to conduct effective site-less studies. In fact, Roots Analysis has identified 25 industry players that are offering their proprietary technology for enabling virtual clinical trials.

These companies offer a range of services ranging from data collection and logistics to patient enrolment. The figure below highlights the distribution of virtual clinical trial service providers by the type of service.

Virtual Clinical Trial Services

These are pressing times and there is a rising demand for companies that can carry out clinical trials virtually. To know more about virtual clinical trials, potential partners, or general market insights, drop a note at rohit.kumar@rootsanalysis.com.