Page 14 - Palliative Care, Trials and COVID-19 Tribulations: First-hand experience shared by the experts at ground zero

Challenges

Shipment of Investigational Product

One of the challenges was that the shipment of investigational products to Malaysia was
delayed due to the lockdown locally and internationally, involving other countries.

Temperature excursion - Interferon and Hydroxychloroquine

There was also a need to improve on temperature excursion. I remember that there was one
whole batch that was quarantined and not able to be used because the temperature excursion
for that batch of medicine was actually exceeded.

Trial administration challenges

There was also trial administration challenges due to time-zone differences with WHO
Geneva. We needed to coordinate large-scale trials under MCO, and this was a big challenge.

One of the challenges was busy clinical settings as well. It was very difficult to recruit
patients when the doctors were all running around. In terms of consent uploading, patients
had to be a bit tech-savvy to take the photo of the consent using mobile scanner app to
convert it into PDF file before we can upload to CRF platform.

“Standard of Care” arm

Investigators’ concern on “standard of care” arm was one of the major challenges that we
had. The standard of care means nothing at all versus an investigational product. Hence, it
tends to have a selection bias. The clinicians will try not to recruit the very severe or the
critically ill ones as much as possible. As a result, most of the patients recruited were those
with milder severity, like on nasal prongs Oxygen. None of our patients recruited were
mechanically ventilated from the beginning.

So, we had to overcome these challenges. We had discussions in the team, and shared
experiences, and made sure everything was running well.