News & Events Recognizing the Regulatory Agencies Supporting the Fight Against COVID-19

Recognizing the Regulatory Agencies Supporting the Fight Against COVID-19

May 28, 2020

The COVID-19 pandemic has spotlighted the courageous work of health care workers, first responders, delivery people, grocery store clerks and stockers, and others in the supply chain providing care, food, and medical supplies to people all over the world.  These essential workers have been selfless in their efforts, and we will forever be indebted to them.

There is another group of essential workers that has not been spotlighted, but whose recent work needs to be recognized and applauded. They are the FDA reviewers – those working at the US Food & Drug Administration whose job it is to review applications for new clinical trials before they begin, as well as medicines and devices before they are approved.  
       
Going Above and Beyond
CTI has been part of more than a dozen different submissions to the FDA and other regulatory authorities across the globe for specific COVID-19 treatments.  We have submitted pre-IND (Investigational New Drug) and EIND (Emergency Investigational New Drug) applications, as well as compassionate/expanded access use programs (which is when a new, unapproved drug can be approved to treat a seriously ill patient when no other treatments are available).
In this unprecedented time, FDA personnel have provided thorough, thoughtful, and helpful reviews of the documents needed to start clinical trials in timeframes that have previously been not thought possible. We have received responses from FDA reviewers as late as 10-11pm, and have participated in phone calls and email conversations every day, including over weekends. These reviews have occurred across multiple FDA divisions including anti-viral, pulmonary, critical care, and infectious disease.  In all cases, FDA personnel have been professional, encouraging, and fully engaged in wanting to help these programs progress as quickly as possible within safety standards.  

Throughout this rapidly changing environment, the FDA has worked closely and consistently across divisions and across clinical studies, frequently providing guidance on study design issues, such as inclusion/exclusion criteria, concomitant therapies, and appropriate endpoints. In cases where extensive pre-clinical and clinical data did exist, the agency has been very helpful in cross-referencing existing INDs or consulting with members of other divisions to expedite reviews, providing the timeliest comprehensive guidance.  In other cases in which limited or no clinical data is available, FDA reviewers have provided counsel and guidance with designing initial proof-of-concept trials. They have also ensured considerations are given to other global regulatory agencies like the European Medicines Agency and the World Health Organization.  
 
           
Special Accolades
Special recognition should be given to FDA team members supporting compassionate COVID-19 treatment requests for individual patients and larger protocol driven expanded access programs. In many cases, these are literal “Hail Mary” requests where hospitals, physicians, and institutional review boards are making concerted efforts to offer critically ill patients any treatment that might benefit  them.  Turn-around time on these requests have been nothing short of sensational, and many patients have  benefited from these quick decisions.  
       
   
The concentrated efforts of the FDA during this pandemic has some similarities to the early days of the HIV epidemic, where early treatments were tested, reviewed, and, in many cases, approved in record time for that era – saving many HIV infected patients’ lives. Both of these scenarios highlight the good practices and excellent outcomes that can occur when there is partnership between motivated healthcare workers, researchers, and government officials. If all parties are completely aligned, treatments and preventions can be developed as fast as possible.

The hope is that all those developing COVID-19 vaccines or treatments against this virus will see similarly accelerated responses from the FDA, without compromising quality. We have seen the first example of this with the swift emergency authorization of remdesivir at the beginning of May and the rapid progress on the first vaccines as they move into patient testing.

A real opportunity exists for the most promising treatments to receive expediated reviews of their New Drug Applications and Biologics License Applications when promising trials meet their primary and secondary endpoints.  It is possible to dramatically accelerate the typical review timelines and provide conditional approvals with substantial post-approval commitments. Ultimately, the FDA will be approving the final vaccines and treatments for years to come to battle COVID-19. 

We will not be able to conquer this pandemic without viable treatments and preventions, and the FDA is a vital component in getting these solutions to the public. 

To Commissioner Stephen Hahn and the FDA, on behalf of researchers across the US, please pass our extensive gratitude to your team and their families for the incredible time and effort shown to this point.

Want to be part of a future COVID-19 vaccine trial?

If you'd like to help further clinical research of a COVID-19 vaccine, you can sign up to be considered for a future trial at ctifacts.com/signup. You can also do so by calling us at 513.721.3868 or texting us at 513.854.3370.
 

Are you a site looking to be part of a COVID-19 clinical trial?

If you are a clinical research site interested in being a part of one our our COVID-19 programs, please contact us at CTIcovid19studies@ctifacts.com.


Do you need help with your current or planned COVID-19 clinical trial?

For more information about CTI's work on COVID-19 and how we can help you, visit our website
 
COVID-19 Training Series with Dr. Rodrigo Athanazio
 

The Year of Hope

CTI Cares - Providing Hope to our Communities
The CTI Cares program was established in response to the great interest of our employees who want to give back to society, and in part due to the prior success we’ve had in charitable giving programs.  Each month, one or more employee-nominated charities is spotlighted and supported by our employees and the company as a whole. This month, in lieu of a single organization, we are encouraging all those that are able to make a donation to support their local charities and nonprofits that are providing aid to those affected by COVID-19.

Looking for a great COVID-19 cause to support? CTI is proud to contribute to Horizon Community Funds of Northern Kentucky's Coronavirus Relief Fund. The donations they receive will go directly to local, nonprofits that are experiencing increased demand for resources in response to the coronavirus. To find out more about the Horizon NKY Coronavirus Relief Fund and to donate, visit 
https://www.horizonfunds.org/coronavirus-relief-fund
 

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