DOH waives Phase 4 clinical trials for COVID-19 drugs, vaccines
The Department of Health said on Friday, Aug. 21, that it will do away with the fourth and final phase requirement of clinical trials for coronavirus disease-2019 drugs and vaccines in a bid to accelerate the national response to the pandemic.
The fourth phase of clinical trials require further testing of a drug or vaccine in a bigger population, that could possibly take years after approval.“Accelerated clinical trials and regulatory approvals in response to threats such as Ebola and Meningitis contributed to mitigating the spread of Ebola and decline in the incidence of Meningitis in the sub-Saharan belt,” it added.
Instead of the fourth phase of the clinical trials, the health department said it will conduct safety and effectiveness surveillance and keep a database of recipients of the drugs or vaccines, who will be informed of the risks and benefits of the vaccination.
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