The Inter-Agency Task Force on Emerging Infectious Diseases (IATF-EID) recently approved several recommendations made by the Sub-Technical Working Group (TWG) on Vaccine Trials as chaired by the Department of Science and Technology (DOST), upon consultation with the Philippines Health Research Ethics Board (PHREB), the national policy making body in health research ethics in the country.
The recommendations:
- All applications for clinical trials should first be submitted to the Vaccine Expert Panel, reviewed by the designated Ethics Boards and submitted to the Food and Drug Administration (FDA) for review and approval for conduct of clinical trials;
- Zoning guidelines on vaccine clinical trials must be issued by the sub-Technical Working Group on Vaccine Development to avoid competition for sites;
- Local government units should prioritize the World Health Organization Solidarity Trial over independent trials;
- The Philippine Health Research Ethics Board (PHREB) should review the Ethical Guidelines for the COVID-19 clinical trials and standardize compensation of trial participants both for the WHO Solidarity Trial and independent clinical trials.
DOST said that the recommendations were made to address some concerns on COVID-19 vaccine clinical trials.
This includes the conflict/competition between the WHO Solidarity Trial and independent trials, as it is expected that the latter may still be conducted in the country as funded by the vaccine developer/manufacturer or their respective government sponsors.
Private companies and clinical research organizations have already started recruiting trialists outside the Solidarity Vaccine Trials.
It was also meant to address the zoning guidelines/assignment of areas to avoid competing trial sites; as with the standardization of compensation for clinical trials.