COVID-19 Therapy Acceleration
For sponsors of investigational products that may be relevant to diagnosing, preventing, treating, or managing the symptoms of COVID-19, FDA has created a new Coronavirus Treatment Acceleration Program (CTAP) to move new treatments to patients as quickly as possible.
Members of the Veristat regulatory team have already interacted with this group and can share a few preliminary takeaways:
- The CTAP team at FDA is extremely responsive. Requests for feedback on clinical study designs and other development questions have received responses in as little as 3 days.
- Sponsors seeking to access this program should be “ready to go.” Sponsors seeking feedback on early development questions or encountering manufacturing challenges should expect to file a traditional pre-IND meeting request.
- For products with existing INDs for other indications, FDA has been requesting submission of new INDs for COVID-19-related indications, rather than allowing an amendment to the existing IND to add the new COVID-19 indication.
- Looking for some guidance? Take a look at our COVID-19 Success Guide: Success Strategies for Conducting Clinical Trials During the Pandemic
For sponsors of products in clinical trials that are not directly connected to the COVID-19 response, the global regulatory agencies have issued numerous guidance documents related to the conduct of trials which are outlined in the blog posts below:
- Veristat Blog: EMA Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic
Regulatory Agency COVID-19 Sites and Guidance On Clinical Trials During COVID-19 Outbreak
|Management of clinical
trials during the COVID-19
pandemic: Notice to clinical
|Guidance on the
Management of Clinical
Trials during the COVID-19 (Coronavirus) pandemic
|Managing clinical trials
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