What specifics should be included in the end of clinical trials of COVID-19 therapeutic drugs?

The regulators present at the meeting believed that the ideal primary endpoint needed to be clinically meaningful, focused on patient performance and survival, measurable, and sufficient sensitivity to the sample size in real-world situations.
, the bidders were also asked to identify methods for dealing with missing research data, events occurring in the middle of the process, and mortality.
for moderate or severe COVID-19 inpatients, regulators have proposed a number of acceptable key endpoints.
these endpoints should reflect clinical benefits and support regulatory decisions.
These acceptable major endpoints, including recovery time up to day 28/29, clinical improvement measured on a sequential scale of up to two points, mortality within 28 days of randomization, and duration of rehabilitation up to day 90.
regulators believe that mortality can be used as a key secondary endpoint in trials that do not use mortality as the primary endpoint.
regulators also discussed the remaining endpoints, including disease progress, days without a ventilator 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 a serious illness, or the proportion of patients who do not need to be hospitalized at a predetermined point in time, may be appropriate.
at the meeting agreed that the end point of virology "may be useful for proof-of-concept research".
at the same time, it was pointed out that the main endpoints of the Phase 3 study should be able to reflect the main objectives of the study.
the development of COVID-19 treatment standards must be taken into account in programme design.
references: iCMRA. ICMRA COVID-19 Treatments and Clinical Trials Workshop #2 - Summary. Jul, 2020. Retrieved Jul 31, 2020 from original title: View point . International Union of Drug Regulators: What specifics should be included in the end of clinical trials of COVID-19 therapeutic drugs?