Clinical Studies

How do I apply to the FDA’s Coronavirus Treatment Acceleration Program (CTAP)?

You can go the FDA website on the CTAP program here: https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap Send your proposal to covid19-productdevelopment@fda.hhs.gov Advice for sponsors seeking to develop agents for the treatment of COVID-19: The overall benefit-risk of this approach for the treatment of COVID-19 has not been established. The variability of individual clinical courses in COVID-19 and the incomplete […]

How does COVID-19 impact clinical studies?

Regulators recognize that COVID-19 may impact clinical trials of drugs, devices and biological products.  Programs for COVID-19 are taking precedence over some other programs, which may experience delays.  Biopharmaeutical companies may also prioritize their programs for COVID-19.  Regulatory agencies are releasing guidance documents for the conduct of clinical trials during the COVID-19 pandemic.  See resources […]

Where should I go for research publications on COVID-19?

Below are resources for the latest research, articles, clinical reports, and commentary on COVID-19.       Resources COVID-19 Open Research Dataset (CORD-19) Dimensions.ai World Health Organization’s Database of Publications on Coronavirus Centers for Disease Control and Prevention – Listing of COVID-19 Publications Cell Press Coronavirus Resource Hub The Lancet Coronavirus Resource Centre New England […]

How do I enroll in a clinical study for COVID-19?

Choosing to participate in a study is your personal decision and an important one. Talk with your doctor and family members or friends before deciding to join a study. To learn  about clinical studies for COVID-19, please go to clinicaltrials.gov.  If you identify a study in which you would like to participate, you or your […]

What are the clinical trials that are being conducted for COVID-19?

The number of clinical trials for COVID-19 continues to grow around the world, and an increasing number of therapeutics are being evaluated.  For the most updated list, please use the resources below. Below are just a few of the clinical trials that are in progress now: Study to Evaluate the Safety and Antiviral Activity of […]