Clinical trials on the front foot for COVID-19


By Mark Glover, Country Manager ANZ, Medidata
Tuesday, 23 June, 2020



Clinical trials on the front foot for COVID-19

Clinical trials have never been more critical as the world faces one of the most significant health crises in recent memory. The COVID-19 pandemic has heightened the need for a vaccine, with cases growing across the world by the hour. Innovative technology in the clinical trial industry is needed now more than ever before. Without the luxury of time, the investment in new capabilities and advanced analytics is critical.

The response to the COVID-19 crisis has seen two critical consequences arise — the need for quickly implemented exceptional measures and an adapted framework for clinical trials. With a global response underway, real-time, detailed reporting and analytics are critical for all stakeholders. Researchers are juggling a wide range of stakeholders from governments, private companies, regulatory bodies and volunteers. Rapid and safe implementation of protocols is vital to address both site closures and social distancing laws.

In the ultimate step for collaboration, businesses across the world have launched a COVID-19 Research Database. This database, a secure repository of de-identified and limited patient-level datasets, is now available to public health and policy researchers to extract insights to help combat the pandemic. This database allows researchers and policymakers access to a diverse repository of real-world data without sacrificing privacy or jumping numerous hurdles.

As the world rapidly changes, with rapid shutdowns and social distancing implemented across nations, clinical trial designs need to keep up. A transition to virtualisation and remote subject visits, as well as the use of central monitoring to maintain oversight of clinical sites, is now vital. Leveraging technology to mitigate risk through increased use of virtual capabilities and advanced analytics will allow trials to flourish in this shutdown environment. Also managing supplies, to ensure the medicine supply chain to patients is not disrupted by lockdowns.

In the face of great adversity, we’re seeing great collaboration between government, academic research institutes, sponsors and supply partners. Notorious for red tape, the clinical trials industry is being supported with enthusiasm like never before, with processes that traditionally take months, resolved in days. While social distancing measures are causing more substantial restrictions on movements, exceptions for essential workers are allowing research to continue, and even thrive in this situation. Companies that would usually compete are collaborating using dashboards and study level metrics to understand the impact on enrolment, patient visits, data collection, query response rates and additional parameters to help diagnose risk areas. This crisis is a global issue, yet a transglobal approach is allowing collaboration like never before.

While this situation has enabled significant growth and collaboration, the smaller end of the clinical trial market is struggling. With the rush towards a vaccine, smaller biopharmaceuticals are dedicating significant resources and capabilities into the ring. Yet these firms also struggle to initiate trials, recruit patients and may even run out of money. What will set apart these businesses from the more prominent firms is innovation. The ability to innovate and adapt is critical to start-ups across the industry and will differentiate the successful from the stilted.

For the first time, clinical trials are centre stage. Never before has the world faced such a healthcare crisis in modern history. However, unlike previous pandemics, we’re sitting in a world full of innovation and technology. Pushing against the traditional tightening of healthcare budgets, we must invest heavily in research or be locked in by COVID-19. Until we can find a vaccine, we are constrained by our restrictions, social distancing and the capabilities of our healthcare systems. We cannot let our healthcare industry struggle under the weight of uncertainty. Research into COVID-19 must continue to build around the world, fast-tracking through the insurmountable red tape that surrounds the research sector. The world is in uncharted waters, facing an opponent that will not rest. Pushing ahead with strength and purpose from a global collaborative stance will be the difference between a vaccine in 24 months and one in five years.

Image credit: ©stock.adobe.com/au/Ekaterina

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