You start to feel a tickle in the back of your throat. It turns into a full-blown cough. Then you develop a fever. You shake and get chills as you try to fall asleep. You know you were around relatives who had recently been on vacation in Europe, so the next day you call your doctor asking to get tested for COVID-19.
But your doctor says no, there are not enough tests. You’ll just have to stay home and try to get through this illness, not knowing what this illness even is.
There has been a shortage of diagnostic tests for the coronavirus in many places in the world, including Canada and the US. As of last week, the US was running only 7,000 tests per day in a country of 330 million. Ontario, the largest and most infected province, along with BC, in Canada is only testing about 1,000 people per day. Canada has tested about 50,000 people. Contrast this with South Korea, which has tested over 270,000 people, and is testing 15,000 per day.
The importance of testing in controlling the spread of coronavirus is becoming clear. South Korea reported only 74 cases on March 17; it was 909 on Feb. 29. The fact that Canada has not been hit as hard as the US is being credited to earlier social distancing measures and more widespread testing.
The reasons for the lack of widespread testing cannot be boiled down to 1 or 2 factors. However, it is obvious that we need better research logistics management to increase testing capacity.
Coronavirus Test Development in the US
To illustrate this need, let’s examine the attempts made by the US authorities to develop tests for the novel coronavirus. After the outbreak in China, researchers in Germany quickly developed a PCR (polymerase chain reaction) test. The World Health Organization (WHO) immediately adopted this test and encouraged countries to mass-produce it and start testing. South Korea did this very quickly.
The US decided to develop its own variation of the German test. While the Center for Disease Control (CDC) developed this test, labs across the country had to send all of their samples to the CDC in Atlanta for testing.
The race was on. The CDC developed a PCR test that involved a negative control reagent that was meant to guard against false positives – when the test says an individual is infected by the virus but in reality, they are not.
After the CDC developed its test, they sent it to state labs to be validated but several labs noticed that the reagent used for the negative control was faulty. Whether because there was a design flaw or because the reagent became contaminated somewhere along the way, the negative control didn’t work and there was a problem with false positives.
The test had to go back to the CDC to fix the problem. In the meantime, the coronavirus was spreading throughout the US so labs needed to test. And because the US had declared a public health emergency, the labs couldn’t develop their own tests without a lengthy FDA approval process. But labs and state health authorities across the US were asking for immediate tests because they knew COVID-19 was infecting the population at a rapid rate.
The FDA reluctantly allowed labs to adapt the faulty test and use it without the negative control reagent. Finally, in recent weeks private companies and labs have been allowed to develop their own tests, and testing is expanding.
Lessons for Research Logistics
In any research project, without competent logistics management, your project is destined for failure. Well-organized logistics management means that you will have the right supplies, at the right time, in the right place. Logistics managers also ensure that everything is packaged, labelled, stored, and distributed correctly so that there is no damage to or contamination with the chemicals and supplies. Somewhere along the way, in one or more of these steps, something went wrong with America’s development of COVID-19 tests.
Here are some logistics lessons we can learn from the coronavirus test development.
1. Protect Supplies through Proper Labelling, Packaging, Storage and Distribution
The first issue was that the reagent in some tests didn’t work properly once the test was developed. Researchers may not have had the right information, which may have led to a design flaw in the reagent. Or there might have been contamination at any number of steps in the process.
Chemicals and samples need to be meticulously labelled, packaged, stored and distributed or it is very easy to have contamination in the lab or in shipping. This is why it is necessary to have expert logistics managers taking care of each of these tasks, especially during a complex project like a clinical trial.
2. Communication and Coordination = Fewer Headaches
Another lesson is that during research and test development, timely and clear communication between all stakeholders is vital. Private companies and state labs seem to have been unsure when they could begin creating their own test or how government decisions, like declaring a public health emergency, would affect them.
Coordination is key for fast-paced research (such as vaccine clinical trials) during a public health crisis such as the coronavirus. All parties need to know when decisions are being made and how it might affect them. Everyone needs to share resources and knowledge for the safety of the entire country. Logistics managers are useful for this because they are highly trained in complex communication and coordination.
3. Be Proactive in Supply Chain Management
Lastly, supply chain management has been a key factor in the development of COVID-19 tests. There is now a shortage of important chemicals that are needed in the coronavirus tests. Forward-looking logistics managers can foresee shortages and supply chain issues so that workarounds can be developed before delays in production occur.
The takeaways from the bumpy road of test development during the coronavirus outbreak are manifold, but one key point is that expert research logistics management can save time and money. If you want to learn how you can prevent your clinical trial from running into logistics issues, please contact us.