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Getting a cure for COVID-19 to market: the truth behind how clinical trials work

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As the number of people infected by COVID-19 surpasses 2 million, its impact on every aspect of our lives continues to escalate. The world is keeping a particularly watchful eye on the medical and science communities as the race to develop treatments and vaccines becomes increasingly urgent. The question is, how long will this take?

A usual timeframe for a vaccine to be developed is between two to five years. This requires expensive resources, manpower and a complicated and lengthy trial process. However, due to the severity of the pandemic we are currently facing, fast-tracked regulatory approvals and never seen before global collaboration, it may mean that a vaccine could be available within 12 to 18 months.

Spreading faster than the coronavirus outbreak itself is the wealth of new information about it. With government regulations ever-changing and news that hundreds of experimental drugs are being tested across the globe, it has made the clinical trial process quite the enigma. So, what does it really take to get a cure to market?

The billion-dollar question

Let’s look at COVID-19 specifically. While this pandemic is the third coronavirus outbreak of the 21st century following SARS and MERS, it’s important to remember that there still aren’t any approved vaccines for coronaviruses. With so little knowledge on the topic, clinical trials are thus critical for understanding the nature of the virus, as well as the efficacy and safety of its experimental vaccines.

But the clinical trial process isn’t easy. New vaccines are generally required to be tested first in a lab, then on animals, and then among a small group of people for safety before being tested in larger groups to observe whether it can prevent disease. Bypassing any of these steps in order to fast-track approval for market distribution can risk the chance of immune enhancement, in which a vaccine weakens a person’s response to the virus.

Around the globe

A silver lining to the uncertainty and loss caused by COVID-19 is the global unification of researchers, governments, pharmaceuticals and universities to tackle the disease. With several new diagnostic tests now in production, repurposed medications and innovative vaccines are entering the trial phase and the power of working together in a time of crisis is as humbling as it is inspiring.

This global push can be seen firsthand in our COVID-19 Clinical Trials Tracker, where we are tracking 912 live clinical trials around the world. There are many variations currently underway and some of the more high profile ones include:

  • Repurposed antiviral drug Remdesivir
  • Hydroxychloroquine, which was originally developed to treat Malaria
  • Actemra, a monoclonal antibody approved for rheumatoid arthritis and for treating the “cytokine storm” immune overresponse in cancer patients
  • Convalescent plasma – a non-drug therapy where blood plasma from recovered COVID-19 patients is transfused into patients who currently have the virus

Closer to home

Closer to home, Australian scientists are playing a pivotal role in this fight, with researchers from the likes of CSIRO, the University of Queensland, the Doherty Institute, CSL, Mesoblast and Vaxine working around the clock to test new and repurposed treatments, and understand the virus.

In Australia, there are currently numerous clinical trials underway, each requiring hundreds of participants in order to adequately gather enough data to analyse the impact of the drugs. This is a mammoth-sized task and one that hinges on a never before seen level of collaboration, not just from researchers and organisations but from everyday Australians – sick and healthy – who are needed to test whether these treatments work.

The road ahead

Ultimately, the road to bringing any sort of vaccine to market, but particularly a COVID-cure, is a long and difficult one. It requires time, resources and a level of global participation and collaboration previously unseen in our lifetime. And, with over 80 per cent of clinical trials typically falling over due to insufficient patient recruitment, the medical science community faces a daunting challenge.

While the rise in patient populations and the global focus on a cure means that more and more people are turning their gaze to clinical trials, a staggering 39 million global participants are needed to bring us closer to combatting the virus.

But it’s possible. Since the beginning of this year, we have witnessed a strong increase in the number of participants signing up to HealthMatch to volunteer for clinical trials. Joining the global swell of support and collaboration brought by researchers, educational institutions, companies and governments, it’s heartening to see a renewed spotlight on the importance of supporting medical research.

When this all settles and hospitals begin to function again, it’s our hope that this level of collaboration will continue in order to support researchers seeking to find new medicines for the many medical conditions for which we have no treatments. In the age of COVID-19 and beyond, I hope we will all continue to be there to support our patients, doctors and scientists to get new medicines out to those that need them most.

Manuri Gunawardena is the Founder and CEO of HealthMatch.

Manuri Gunawardena is the Founder and CEO of HealthMatch
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