NHS Advises COVID-19 Related Risk Assessment of Phase I Trials

In a recently released statement, the NHS has advised all companies that are conducting early phase clinical trials to seek confirmation that the trials have undergone a risk assessment in relation to coronavirus (COVID-19). As per the statement, this is likely to result in the halt/termination of some of the trials.

With several governments announcing social distancing and other measures to reduce the spread of COVID-19, a surge in more news associated with trial termination is expected. In fact, 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 also urged pharmaceutical companies to switch to virtual clinical trials. In a recently published article, we discussed, in detail, the key insights associated with virtual clinical trials.

Big Pharma and Virtual Clinical Trials

Virtual clinical trials already appear to have decent adoption across the pharma companies. Roots Analysis conducted an analysis of the top pharmaceutical companies. The detailed analysis included those players that have sponsored/plan to sponsor a virtual clinical study; these include Pfizer, Johnson and Johnson, Sanofi, Novartis, GlaxoSmithKline, and Amgen. The figure below highlights some of these initiatives:

Pfizer: A Pioneer in Virtual Clinical Trials

In 2011, Pfizer pioneered the first-ever virtual trial, known as the Research on Electronic Monitoring of Overactive bladder Treatment Experience (REMOTE) trial. It was a randomized clinical trial, which was conducted using mobile phones and web-based tools. This allowed the patients to participate in the trial regardless of their proximity to clinical sites.

However, the trial observed significant patient drop-out. In fact, only 18 individuals finally received the treatment. In spite of this, the results of the study were consistent with those of a conventional study. Trial investigators conjectured that the trial failed to recruit patients because of the complex online registration process. Nevertheless, the trial paved the way for other companies to explore the possibilities of virtual clinical trials.

With time, a number of pharmaceutical companies have adopted virtual clinical trials. Amid the ongoing COVID-19 crisis, 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. Also, check out our report page to know more about the novel clinical trial designs.