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At a recent remote meeting of the International Union of Drug Regulators, representatives of ICMRA member agencies considered potential endpoints and agreed on acceptable end points with a view to facilitating rapid and consistent clinical trials of COVID-19 drugs.
The regulators present at the meeting believe that the ideal primary endpoint needs to be clinically significant, focus on patients' ability and survival, and be measurable, and should be sensitive enough to the sample size in real-world situations.
, the bid also asked the bidder to determine the methods used to deal with missing research data, events occurring in the middle of the process, mortality rate.
for moderate or severe COVID-19 hospitalizations, regulators have proposed a number of acceptable major endpoints.
these endpoints should reflect clinical benefit information and support regulatory decisions.
These acceptable main endpoints include rehabilitation time up to day 28/29, improvement in clinical status measured using sequential gauges to two points, mortality within 28 days of randomization, and duration of continuous recovery up to day 90.
regulators at the meeting believed that mortality could be used as a key secondary endpoint in trials that did not use mortality as the primary endpoint.
regulators also discussed the remaining endpoints, including disease progression, days without ventilators and recovery rates, but no consensus has been reached on these issues.
study of patients with mild COVID-19 mild illness, regulators said it was "probably not appropriate" to use mortality as the primary endpoint.
depending on the specific purpose of the study, other endpoints, including the rate of progression to developing a serious illness, or the proportion of patients who do not need to be hospitalized by a predetermined point in time, may be appropriate.
regulators at the meeting agreed that virological endpoints "may be useful for proof-of-concept research".
, it was pointed out that the main endpoint of the Phase 3 study should reflect the main research objectives.
in the design of the program, it is necessary to take into account the development of COVID-19 treatment standards.
references: ICMRA. ICMRA COVID-19 Treatments and Clinical Trials Workshop #2 - Summary. Jul, 2020. Retrieved Jul 31, 2020 from original title: View point of view. International Union of Drug Regulators: What specifics should be included in the end-of-clinical trial of COVID-19 therapeutic drugs? ▽ concerned about the public number of WeChat.