Page 9 - Palliative Care, Trials and COVID-19 Tribulations: First-hand experience shared by the experts at ground zero

The Success Part of This Trial

The success of this trial was that it streamlined all the trial initiation due to public health
emergencies. We know that this pandemic is spreading fast, and we need to come up with a
solution, whether it works or not.

This trial managed to get the fastest ethics clearance by the Medical Research and Ethics
Committee (MREC) within five days, thanks to Dato’ Dr. Goh Pik Pin, former director of
Institute for Clinical Research (ICR) and the ICR team’s effort. The trial also received
fast-tracked Clinical Trial Import Licence (CTIL) clearance by the National Pharmaceutical
Regulatory Agency (NPRA), Malaysia within seven days, evaluated by eight reviewers from
the NPRA working day and night.

We also received RM81,000 study grant. Centre for Clinical Trial (CCT), ICR located in
Ampang Hospital has distributed all the investigational products efficiently to all study sites
in four days. Thanks for the teamwork.

Streamlining the Clinical Trial Process

I would like to share with you the timeline (Figure 1). As you can see, none of our clinical
trials will get approval this fast. For MREC approval we applied in early April, and we
obtained the approval 4 days later. NPRA approval was achieved within seven days. We
managed to distribute all the investigational products to the clinical sites within 4 days.

Figure 1: Timeline for Solidarity Trial.

We recruited a total of 217 patients; 63 of them were on Remdesivir, 30 of them were on
Hydroxychloroquine, 47 on Lopinavir/Ritonavir, 5 on Interferon, and 72 of these patients
were on the standard of care.

We received very good support from nine major MOH hospitals led by Datuk Dr. Suresh
Kumar, Infectious Disease (ID) Physician with nine ID Physicians as trial investigators.
There were a total of 62 co-investigators facilitated by researchers from the ICR.