Page 13 - Palliative Care, Trials and COVID-19 Tribulations: First-hand experience shared by the experts at ground zero

Clinical Trial Innovations

I would like to say that the innovations were so great in this study because this was the first
study to allow virtual consent taking.

We only have one hard copy of the consent form for the patient. Once the patient understood
and signed the consent, we taught the patient to use a mobile phone - scanner app to take the
photo of the consent and save as a PDF file. Then the patient sent the file to our mobile
phones, and we uploaded the PDF consent form to the electronic Case Report Form (eCRF)
website. Hence, this way, we can minimize COVID-19 exposure of the investigators without
compromising the Good Clinical Practice (GCP) principles at the same time.

This trial was one of the largest trials of COVID-19. We have contributed about 200 over
patients out of 12,000 patients globally. It had a fast-tracked record in approval.

We had regular meetings with the international counterparts. All the countries agreed to meet
because it is a global trial. Some of us had to sacrifice our nighttime because of many
countries with different time zones like European countries etc. Every Wednesday at 9:30PM
Malaysian time, all the investigators would meet on the Zoom platform. Then we discussed
issues about investigational products, re-distribution, eCRF issues, sharing difficulties and
success stories among each of the countries.

Monitoring was done by pharmacists and experienced ICR study monitors. We went through
a stringent monitoring record as well.

Regarding the web-based CRF, we used Castor’s EDC (Electronic Data Capture), a simple
data entry system. It started with inclusion criteria of eligibility, then consent file upload.
Next, we chose the available investigational product on our site. It has a simple medical
history, classification of the COVID-19 disease severity data entry fields. Then,
randomization. Later on, we keyed in the treatment outcomes. That’s about it. So, it was very
adaptive and simple trial data entry without going through the nitty-gritty of traditional long
clinical trial paperwork.