Title: Clinical Trials in the Era of COVID-19: The Changes You Need to Make Now
Date and Time: March 18th at 2-3:30 PM ET
NIH guidance for federally funded clinical research (3/16/19)
DOWNSTREAM - - - -
It is early days still, and not the time to deal with this; but some who experienced the flu epidemic a few years back saw elective surgeries cancelled at hospitals, as the beds were full. This economic impact was severe to healthcare institutions.
The downstream impact for clinical research departments and professionals at UAB at that time was:
1. Hiring freezes
2. Replacements of open positions due to attrition- closed.
3. Salary freezes
Important to anticipate how COVID-19 may have a downstream effect, so that proactive, rather than reactive, measures by those who are experienced in the field can be put in place.
We don't do very well quantifying effects of a dampened clinical research system. And not my aptitude to tackle, but important to think about as we use this crowdsourced space to learn about COVID-19 response and the future.
Emotional Coping Strategies for COVID-19 (Focus on Nurses): https://voice.ons.org/news-and-views/emotional-coping-strategies-for-covid-19?utm_source=email&utm_medium=email&utm_content=template_id&utm_campaign=Voice_Newsletter_Member
Interesting twitter discussion by ID doctors on hydroxycloroquine usage in COVID and a rapid enrolling RCT about this.
Check out #hct; @boulware_dr
In Minnesota, they rapidly enrolled 479 patients in sort order. Would love to hear from this study coordinator/CRN there about process!
FDA has just issued a guidance document, for public comment on COVID-19 clinical research.
Located at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic?utm_source=FOMAT+NEWSLETTER&utm_campaign=757628d360-EMAIL_CAMPAIGN_2020_03_25_09_49&utm_medium=email&utm_term=0_d20063e347-757628d360-306330045
hi everyone: Harvard has put our study on hold until at least the beginning of May, and since I don't think we are going to be out of the woods then, I would not be surprised to see that extended till after Memorial Day.
I hope you are all taking care of yourselves, and to those of you on the front lines of this disaster, please stay safe and know that we are all with you in spirit.
Our regulatory director drafted a memo to the IRB regarding practices we wanted to utilize for all trials during this period. It included activities such as virtual visits and shipping oral study drug. The IRB approved the memo. We also developed a checklist for shipping oral study drug- who needs to be contacted for approval.
International Association of Clinical Research Nurses
2331 Rock Spring RoadForest Hill, MD 21050, USA443-640-1041 (Phone)443-640-1031 (Fax)firstname.lastname@example.org