Much of the global clinical trials sector has been disrupted by the COVID-19 pandemic. With concerns for patient and staff safety, as well as issues with resourcing and supply diversions or interruptions, many clinical trials have been forced to adapt. Indeed, many regulatory bodies, from the U.S. Food and Drug Administration to the European Medicines Agency to Japan’s Pharmaceuticals and Medical Devices Agency to Australia’s Therapeutic Goods Administration, have released updated guidance to assist industry, investigators and institutional review boards navigate this complex situation. Trials that haven’t been able to adapt have ground to a complete halt. During this apparent stasis, it is easy to feel that moving forward isn’t a remote possibility. But as with all difficult challenges, there are opportunities.
This time presents an opportunity to get ready for the inevitable restart of the clinical trial sector. As with all stoppages, once barriers are removed, a bottleneck will form. “Now is the best time to reach up until the point of implementation, especially in terms of recruitment. It’ll place you in the best position to beat the rush, to move ahead of competitors, to conduct a clinical trial that is timely and cost-effective,” says Dr Tina Soulis, CEO of Neuroscience Trials Australia.
From scoping, preparing HREC submissions, negotiating site budgets, and even conducting feasibility studies (which can be completed remotely), there are a number of activities to be done before a patient volunteer walks through the doors of a clinical trial site. And these activities can be done now.
Neuroscience Trials Australia is currently operating, for the most, business as usual, to help move projects to a stage where they are ready to recruit. “Investigators and sponsors have truly seen the Australian advantage,” explains Tina. Australia is a leader in clinical trials, with a reputation of medical research excellence, a robust healthcare system, efficient regulatory processes and generous tax incentives. Tina continues, “The added advantage now is the way the country has handled the COVID-19 pandemic. With an effective flattening of the curve, Australia, its medical research sector and its healthcare system, are in a much better place to return to a relative normal compared to other countries around the world.”
And a return to a relative normal is sorely welcome. Tina muses, “COVID-19 has highlighted how important clinical trials are, how important the process of drug development is, from the discovery in the petri dish to testing its safety and efficacy in people. I’m excited to return to full operational capacity so we can begin to help patients, to save and improve lives.”