China has become the most popular region for clinical trial research over the last few years. A recent case study showed clinical trials had increased by 451% between years 2010 and 2017. This increasing investment by large companies like BeiGene, Ltd. is a result of the continuing effort by Chinese regulators to improve healthcare facilities to compete on a global scope.
As a result, China has become the go-to place for early-stage US-based biotech companies looking for help in testing, designing, and manufacturing potential drugs.
However, the recent epidemic has disrupted ongoing clinical trials. With tens of thousands coronavirus infections (COVID-19) and more than 1000 death, China’s government has imposed travel bans to prevent further spread.
Researchers have since been working round-the-clock to find a cure for the new virus; this may not happen soon. The predicament is affecting other areas of clinical research, particularly those run by CROs in two ways:
Initially, the impact was minor as the travel bans, and workplace closures coincided with China’s Lunar New Year celebrations. However, CROs are worried that the restrictions may last longer, disrupting ongoing experiments and drug development projects as most of the CROs are located in Wuhan, where the outbreak is said to have started. Also, since some people don't show sick symptoms, it makes it even more difficult to detect the disease.
There’s also the fact that hospitals are currently not focusing on clinical trials; most of them are treating infected patients. All these factors have led to delays in the launch of new studies, with some contract research organizations unable to send staff out to the fields to monitor trial sites. Since some experiments are more sensitive than others, CROs may end up being a few weeks behind schedule.
Also, some experiments may be put on hold. For example, clinical trials testing a drug on cell cultures or animals are nearly impossible if the drug has not been made. What’s more, experiments that need enough staff to care for research animals have come to a halt rendering months to waste. Some clinical trials affected include:
Contract Research Organizations can leverage on two technologies to minimize disruption and facilitate ongoing clinical trials:
Virtual experiments will reduce the burden of making study visits. This is because the companies will use web services and telemonitoring to perform most or all the research. Participants are recruited online, screened for eligibility through web-based questionnaires, and electronic diaries created. The proliferation of smartphones and remote health monitoring devices like the Mitra makes virtual trials an even more promising strategy.
The invention of sampling techniques like microsampling presents alternatives CROs can leverage to help carry on with their clinical trials. Also referred to as Volumetric Absorptive Microsampling, the process involves the collection of small (usually 10-20 microliters) and precise volumes of biological fluid for tests or experiments.
The technology was developed to solve the limitations of Dried Blood Spot and has spawned new uses such as remote sampling. Remote sampling is particularly handy for CROs looking to collect samples from participants living in Wuhan as the region is under federal quarantine.
The institutions can garner on VAMS to perform remote patient monitoring. VAMS devices like Mitra, will be particularly useful in influenza type viruses or viral pathogens and research applications as it eliminates phlebotomy for vaccine responses, enables researchers to understand the efficacy of seasonal vaccines for flu among other benefits. Other benefits of remote sampling include:
Click here to know more about the remote sampling device, Mitra.