ARC COVID-19 vaccine trial to continue on schedule

In response to recent announcements by the CDC and Pfizer that there might be a COVID-19 vaccine available by late October 2020, questions have been raised about the vaccine trial underway in Austin, conducted by Austin Regional Clinic Clinical Research. ARC has responded in a recent news report on KXAN-TV that the Pfizer COVID-19 vaccine trial will continue. Dr. Anas Daghestani, CEO of ARC has said, “Our timeline is still the same, because we have to go through a very methodical process to ensure we have the right information, we are enrolling the right patient, and we are following all the safety protocols.”

The New York Times has reported that over the past week, both Dr. Anthony S. Fauci, the country’s top infectious disease expert, and Dr. Stephen Hahn, who heads the Food and Drug Administration, have said that a vaccine may be available for certain groups before clinical trials have been completed, if the data is overwhelmingly positive. But, clinical trials will continue as scheduled.

ARC is currently in the enrollment phase of the trial which means we are calling all interested people, confirming by phone that they are qualified for the study and still interested, and booking an appointment for them to come in. We are on track to complete this phase next week, which means we will have all 250 people we need to enroll in the trial.

So far we have had over 3,500 people express interest in participating, and of the people we have spoken to, 88% are both qualified and interested to participate in the study.

Their first visit includes: informed consent (where they learn all about the study), evaluation for inclusion in the study (enrollment), exam and lab tests, Study Intervention (vaccine or placebo which is blinded), and learning all about their responsibilities for using their symptom diary and when to call us if any problems.  They're in the office over 2 hours and are free to decline participation at any point. 

Following the first visit, there is a very strict timeline to follow for the remainder of the study. That will not change.

“There’s an ongoing process whether by phone or by follow up to see if you’ve gotten exposed to the infection, did you get an infection,” explained Dr. Daghestani. ”And then we compare those who have had the vaccine to those who haven’t had the vaccine, so the study could continue for a long time.”

In the meantime, companies like Pfizer continue monitoring data from thousands of participants across the country.

“Because COVID is still active and still with us, I suspect within a month or two we could see early results of how effective it is,” said Dr. Daghestani. “Immune response to the vaccine can be determined in a few weeks.”

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Tags: ARC Clinical Research, Anas Daghestani MD, COVID-19 vaccine trial

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