China faces clinical delays during coronavirus outbreak

As China responds to the 2019-nCoV virus outbreak, executives of Chinese life sciences companies have pointed out that efforts to fight the virus could affect clinical trials across the nation, including postponement of new trials and continued enrollment of ongoing trials and increased usage of remote monitoring.

Dan Zhang, executive chairman of CRO Fountain Medical Development Ltd., told BioCentury that many clinical trials may be delayed, particularly in the Wuhan region because people cannot get into or out of the city. He added that other regions also face problems with clinical work.

Beijing Cancer Hospital has requested that Fountain Medical delay the start of new trials and enrollment in ongoing trials, according to Zhang. “That’s already happening in Beijing, so I'm pretty sure that a similar situation occurs in Guangzhou, in Shanghai,” he said.

Several GCP centers, including Beijing Cancer Hospital, have requested remote monitoring be considered as a possibility for trials that are under way so that company staff do not come to hospitals unless absolutely necessary, said Zhang.

Although GCP centers near Wuhan have stopped some clinical work, centers outside of Wuhan are also slowing down as they turn their attention to treatment and prevention of the virus, he said. “The government is asking everybody to focus their attention on the treatment and prevention of the infectious disease,” he said, adding that GCP centers have to develop plans to support the activities.

Life sciences software company Jiaxing Taimei Medical Technology Co. Ltd. said that 189 clinical centers nationwide had issued work guidelines and regulations related to clinical trials in response to the epidemic, as of Jan. 31. Taimei launched a remote clinical trial platform Monday including project initiation, data management, drug supply monitoring, and imaging consultation.

Jin Li, chairman and CEO of Chengdu-based HitGen Inc., agreed that the current need to provide diagnosis, medical observation and treatment to confirmed and suspected patients with 2019-nCoV acute respiratory disease could affect ongoing clinical trials in the short term. “However, there are already calls for balance in not neglecting the use of hospital resources for the normal treatment of other patients,” he said.

Zhang said the current travel restrictions could affect the export of drugs or APIs from China as well as many collaborations, especially global trials that require coordination. People need access to the trial sites, he said, adding that “travel within China is a challenge right now.”

“Certain outside training, QC/QA will definitely be affected,” he said.

Zhang said both industry- and investigator-sponsored trials will be hit by the crisis. Twenty percent of industry-sponsored clinical trials in China have a site in Wuhan, the epicenter of the viral outbreak, according to ClinicalTrials.gov (see “Coronavirus Epicenter a Hub for Clinical Trials in China”).

Clinical trials could face further complications if China's National Medical Products Administration (NMPA) is stretched thin. Zhang expects NMPA inspections could be affected. The agency's staff are preoccupied with the virus, and it may not have the manpower to handle inspections, he said.

On Monday, China’s Center for Drug Evaluation said it will suspend in-person delivery of documents and consultations and will instead receive materials by mail and provide online or telephone consultation. CDE will offer increased hours for telephone consultation and allow sponsors developing products to prevent or control the coronavirus to contact the center “at any time.”

Zhang said the difficulties may persist until the spread of the coronavirus is controlled. He hopes that if the total number of new cases crests in the next few weeks, that could be a turning point that would signal a positive outlook for return of normal business.

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus. The 2019-nCoV content is free to all who visit the site.

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