China’s booming clinical trials sector, a critical part of the government’s healthcare modernization initiative, now faces an imminent threat by the fast-spreading coronavirus. Although global and local biopharma companies have invested billions to tap into and expand in the country, they face disruption and potentially losses associated with delays and cancellations.

Major Impact Anticipated

According to a recent report by Reuters, nearly 500 clinical trials are based in the city of Wuhan, the epicenter of the crisis—where more than 1,100 people have died and over 44,000 infected in all of China. 20% of the world’s clinical trials are now conducted in China according to GlobalData Plc. With what is essentially a “lockdown” of Wuhan and wider areas in the province of Hubei the ongoing operations of the region’s (and nation’s) clinical trials is a certainty. For example, as local, provincial and national government efforts to stop the virus’ spread intensify, many practical activities associated with clinical trials are curtained. For example, patients cannot necessarily make it to the local hospital to participate in a given clinical trial. Moreover, many patients may fear going to hospitals even if the path is clear due to fear of exposure to the virus.

Examples in Wuhan and Beyond

The recent Reuters report, authored by Tamara Mathias, Roxanne Liu and Manojna Maddipatla introduce some tangible examples of impacted studies including a Novartis study involving an experimental treatment for a rare blood disorder as well as a cancer study involving Chinese industry sponsor BeiGene Ltd (more than 20 clinical trials in Wuhan alone) and a study centering on spinal arthritis from Chinese biotech Tasly Pharmaceutical Corp

Many drug companies report that it was too early to determine on the outbreak’s consequences but undoubtedly there is a material impact suggests RocheZai Lab Ltd and Hutchinson China MediTech Ltd (Chi-Med)

In Beijing and Guangzhou, a couple of investigators report that BeiGene’s cancer drug tislelizumab may be impacted in studies as those cities work to contain the virus. Apparently clinical study patient enrollment has been, not surprisingly, hampered.

Public Health Infrastructure

The cause of many of these viruses may be bats. Perhaps the origin was a “wet market” where outdoor stalls are compact together, with narrow lanes and huge crowds of visitors shopping for cuts of fresh meat and produce. Cages of chickens or other animals could abut a butcher counter where fresh meat is chopped, packaged and sold to consumers. Vendors may skin hares while seafood stalls display all sorts of fresh fish and shellfish. These wet markets make it easier for “zoonotic diseases” to skip from animal to human.

Such a scene in the North America, Europe other “developed” regions wouldn’t be found because of tightly controlled public health law, rules and infrastructure requirements. As China’s industrialization leads to huge, crowded cities, perhaps practices of a more rural, decentralized past must give way to more controlled, contained and regulated protocols to avoid such outbreaks moving forward.

Source: Reuters

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