How have trials been affected by the Sars-CoV-2 pandemic? 

Clinical trials awareness week, day 3:  How are trials being affected by the Sars-CoV-2 pandemic? 1

Our ongoing trials have most certainly been affected by the global Sars-CoV-2 pandemic.  How each specific research site worldwide is affected would depend on what country they are in, local laws and regulations guiding movement of people (social distancing, lockdown, etc), border restrictions limiting import and export of goods, medicines and biological samples, and whether other parts of the economy are functioning (couriers, public transport, etc).

For the protection of our existing patients, we have limited the number of patients coming for their scheduled visits and planned the time of their visits carefully so they overlap with each other as little as possible.  This is to reduce the number of people sitting in the waiting room at any given time.  We have managed to continue seeing our patients on existing trials, as they need to be monitored for safety and be issued with their study medication supply.  But we have not enrolled any new patients onto trials, or started any new trials since lockdown began in South Africa.

We have also implemented very strict infection control measures at our research site.  Over and above the careful scheduling of patients, every person who enters our premises (patients, staff, doctors, monitors, couriers) are screened and their temperature taken.  Everyone is encouraged to wear a mask, and social distancing guidelines are adhered to.  We are all washing our hands frequently and sanitizing rooms, examination beds and medical equipment after every single patient.

We have had our resilience and ingenuity tested during this time:  Shipping of biological samples have been interrupted depending on which country they get shipped to, some blood samples have had to be frozen and stored on site until such time as we can ship them.  Some blood tests have had to be done by our local Ampath lab in order to get timeous results that affect patient safety monitoring.  Certain courier services have been suspended, and we have had to make extra effort to ensure that the supply of medication for our patients is not affected.  We will continue to tackle these challenges in the weeks and months to come.

Why is it critical that clinical trials continue during a pandemic?

“The absence of any scientific guidance made us feel and behave like helpless homeopaths. We had no effective therapies so we threw all sorts of likely ineffective therapies…at them. No one in the world knew when these patients needed to be intubated or how to manage the vent once they were intubated.”

https://emupdates.com/surge/

Those are the words of an ER doctor working in New York during the pandemic.  His chilling account describes how doctors and nurses are in desperate need of proven guidelines for treatment and intubation.  They felt they were doing their best to keep patients alive but didn’t know which therapies would be effective as there were no trials to guide them.

Practicing blindly is a very scary place to be, for both doctor and patient.

Covid clinical trials

Some may argue that trials are not so important during a pandemic and that all medical hands should be on deck helping the front-line emergency department workers, but we disagree and here is why:

Clinical trials are as important as ever during a pandemic, because now, more than ever, we need new therapies, and good evidence-based guidelines to assist in treatment decisions.  This won’t happen unless clinical trials are ongoing.  And, of course, without clinical trials we will never have the vaccine we so sorely need.

The same doctor quoted above said this in his article:

“We had never felt like we could do so little for so many who needed so much…care coordinated by doctors powerless to stop the disease laying waste to your lungs.”

https://emupdates.com/surge/

After the peak of the cases in New York had passed, he said:

“And we have a lot more experience managing COVID, though still very little science to guide us.”

https://emupdates.com/surge/

And his prediction for the future:

“a steady stream of deaths…until we get a vaccine, a cure, or herd immunity.”

https://emupdates.com/surge/