BEIJING – Multiple China-based clinical trials have been put on hold as the country concentrates on its fight against COVID-19. To curb the spread of the novel coronavirus that has infected over 72,000 people and killed nearly 2,000, China has imposed travel and transport restrictions, making trips difficult or even impossible for patients and physicians.
In Wuhan, the epicenter of the outbreak, which alone has seen around 18,000 people infected, Yue Wang’s site management organization (SMO) is conducting 51 trials, including 39 oncology studies. She said that many visits have been cancelled.
The outbreak and the lockdown have made clinical researchers worry about how to continue their studies. The Drug Information Association’s China branch (DIA China) drew trial experts together last weekend to discuss business continuity plans for clinical studies. As vice president of Shanghai-based SMO Clinplus Co. Ltd., Wang was one of the speakers and she spoke of the situation in Wuhan.
Her SMO has stopped enrolling new patients for oncology studies. Patients who are already enrolled in a trial can still visit the hospital after they have their body temperature checked and received CT scans. “But almost no one at all arrived,” she said.
“Researchers advise patients not to come to the hospital as pneumonia is more dangerous than cancer, and cancer patients bear a higher health risk if they are infected with the coronavirus,” she said. “As well as this, patients also find it impossible to come in as public transport has stopped running in the city and no one is allowed to drive.”
This is not an isolated example. Researchers in other parts of the country have also been encountering the same issues. The massive scale of the lockdown and fears of contracting COVID-19 have affected registration, patient enrollment and follow-up visits.
Trial experts said at the DIA China event that although there has not been a notable impact on NDA filings, site inspections are expected to be delayed. This could in turn delay approvals.
“Some principal investigators have asked to halt the screening process, and patients are not willing to go to the hospital for screening because of the outbreak,” a researcher from Shanghai Haiyan Pharmaceutical Technology Co. Ltd. told BioWorld about how enrollment in many clinical trials has been suspended.
Yang Song, healthcare analyst at Cinda Securities, also said there may be temporary impacts on pre-clinical work such as IND preparation, as people are currently finding it hard to return to work.
“Biotech companies will have to think about these impact possibly lasting for three or even six months, and make plans accordingly,” he told BioWorld.
“From what I know, even non-respiratory doctors in Tianjin, Zhejiang and Jiangsu were sent to the frontline to fight the coronavirus. It is impossible to have follow-up visits,” Fei Xiao, investment manager at Beijing-based iMeta Health Information Consulting Co. Ltd., told BioWorld.
Xiao added that clinical research associates are not at their workplaces, so trials are left unmonitored, and CROs such as Fountain Medical Development Ltd. have put their trials on hold. Fountain’s CEO Dan Zhang has not yet responded to BioWorld’s request for comment.
“Clinical trials for oncology drug candidates or those that require weekly medication cannot go ahead,” Xiao said.
According to a survey by Beijing-based Linkstart SMO Ltd., which involved 363 research institutes across the country, more than 92% of the respondents have halted patient enrollment in their clinical trials. Over 90% of them have adjusted their plans for visits, including halting or delaying visits, or changing the mode or location of visits. More than 85% of them could not give a specific timeframe for when work would resume as normal.
Researchers are responding to the challenges in order to minimize impacts. If conditions allow, they can mail oral medications to patients and give detailed instructions. For intravenous drugs, patients can visit local medical centers to ask for injections if the drugs are sold on the market. They are also trying to minimize onsite visits while stepping up protection for clinical research coordinators.
Impacts of the challenges clinical trial progress remain to be fully evaluate. But experts said biotech companies, especially clinical-stage startups, are now worried about their financial situation in case there is a serious delay in their trials.
“Biotech entrepreneurs are worried about bankruptcy if work cannot resume and they still need to pay salaries,” iMeta’s Xiao said. “Their financing could also be affected, as investors expect clinical trial milestones within a specific timeframe. If there is a delay, it will affect the founders’ shareholding.”