While efforts to slow the spread of coronavirus (2019-nCoV) are well underway, creating an effective vaccine to prevent the spread could take another 18 months, according to the latest updates from the World Health Organization. However, a specialist clinical research organisation believes that making changes to the way that clinical trials are conducted could be key to optimising the response to similar situations in the future. Virtual Clinical, a CRO working with global pharmaceutical leaders, suggests that decentralising clinical trials could bring vaccines to market much sooner.
Media sources are currently generating buzz with reports that clinical trials for a coronavirus vaccine could be up and running within just three months, especially with potential vaccine candidates taking just weeks to identify, rather than years. However, Virtual Clinical says that the real bottleneck will be testing in humans beyond phase 1 trials. Phase 2 and phase 3 trials are expected to require significant organisation in order to successfully enrol a sufficient number of patients in a short period of time following identification.
Traditionally, trials such as this are centralised at investigational sites such as hospitals, but challenges such as patient visiting schedules, use of hospital resources, and delays in inputting data from investigational sites are potential time sinks impacting the highly time sensitive process of preventing an epidemic. The solution that is being presented by Virtual Clinical is decentralised trials, which are managed remotely with support from virtual clinical associates. Decentralised trials remove the need for scheduled, on-site assessments, enabling clinical teams to experience a faster set up, improve recruitment rate, and boost their access to real time, quality data.
“When we’re dealing with global health risks, time is of the essence, and what pharmaceutical companies should be focusing on now is quicker set ups and faster results when we really need it most,” says Virtual Clinical CEO Mark Thomas. “Using virtual clinical trials, enrolment will be quicker, costs will be reduced, and symptom and safety reporting can be more accurate.
“We need to learn from the past, and look at how it took the U.S. Food and Drug Administration more than five years to approve the Ebola vaccine after the start of the first human trials. The first coronavirus cases were reported in Wuhan on December 31st last year, and in less than two months there have been more than 1100 deaths, which highlights just how important it is to improve processes for efficient response times to risk.”
Both the Trump Administration and researchers in Hong Kong have announced that they have entered into early stage trials for vaccine development for coronavirus. However, it is estimated that following phase 1 trials, the more complex phase 2 and phase 3 trials that involve human testing could mean that the vaccine will not be available until at least summer 2021.
Experts are speaking out, with some stating that more than half of the global population could be infected with coronavirus (2019-nCoV) if the virus is not adequately maintained. Independent outbreaks caused by newly infected travellers without symptoms are expected to rise in the coming months, especially throughout major international cities. It is hopeful that, through dedicated efforts, the spread will be prevented, but coronavirus is unlikely to be the last global health risk experienced. A World Health Organization report says that the threat of a lethal pandemic is ‘very real’, estimating that 50 to 80 million people could die as a result of a respiratory pathogen in the future.
To find out more about Virtual Clinical, visit www.virtual-clinical.com