Resource Center: COVID-19 and Clinical Trial Operations

COVID-19 Webinar Series

Join the next COVID-19 Webinar

Join thousands of your peers in WCG’s weekly online panels, where clinical trial and public health experts provide the latest insights on COVID-19 and discuss the biggest questions and topics you submit.

Register for the next webinar

Submit a topic or question

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Part 2: Clinical Trials in the Era of COVID-19: Changes You Need to Make Now

[3/25] Our panelists cover how clinical sites and institutions are making decisions about what research should continue during COVID-19, what resources site teams are utilizing to shift study visits to virtual and remote assessments, and what changes are being made to protocols based on site policies and precautions. Also presented is the participant perspective: how we can manage fear, change, and messages about “non-essential” research priorities.

 

Part 1: Clinical Trials in the Era of COVID-19: Changes You Need to Make Now

[3/18] From protocol amendments to participant recruitment and retention, the impact of COVID-19 could be enormous. What can you do to minimize the disruption to your ongoing, or upcoming, clinical trial? Our panel of experts from NYU Langone Medical Center and WCG discuss ways to reduce the impact of this pandemic on your studies to keep them on track.

 

COVID-19 Preparedness for Health Care Institutions

[3/13] In this webinar, experts from the FDA and Massachusetts General Hospital discuss what we know, and don’t know, about the nature and epidemiology of COVID-19, what’s happening as we work to develop vaccines and therapeutic agents, and how health care institutions are preparing for COVID-19 across different divisions.

key takeaways from Dr. Paul Biddinger

key takeaways from Dr. Scott Gottlieb

 

Recent Insights from WCG


COVID-19 Clinical Trial Tracker

Monitor the progress of clinical trials for COVID-19 treatments and vaccines, leveraging data from the WCG Knowledge Base™.


Recent news on COVID-19 and clinical trials

News provided by WCG FDAnews and WCG CenterWatch

Mar. 26

FDA Issues Emergency Use Authorization for Ventilators

The FDA issued an Emergency Use Authorization (EUA) for certain 510(k) cleared ventilator devices in response to the COVID-19 outbreak.

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Mar. 26

Mesa Biotech Gains FDA’s Emergency Clearance for Coronavirus Test

Mesa Biotech has received an Emergency Use Authorization from the FDA or its Accula novel coronavirus diagnostic.

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Mar. 26

Mologic Begins Accelerated Validation of COVID-19 Test Prototype

Mologic announced that is accelerating early validation of its COVID-19 diagnostic test designed for home use.

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Mar. 26

DOJ Targets Fake COVID-19 Vaccine Kit Website

The Department of Justice has taken its first enforcement action for fraud related to COVID-19 vaccine kits, taking a website operator to court for allegedly conducting a wire fraud scheme.

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Mar. 26

Pfizer and Mylan Delay Merger Due to COVID-19

Mylan’s merger with Pfizer-subsidiary Upjohn has been pushed back to the second half of 2020 because of the COVID-19 outbreak.

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Mar. 26

Bristol-Myers Squibb Says MS Drug Launch Delayed due to COVID-19

Bristol-Myers Squibb is delaying the launch of its multiple-sclerosis drug Zeposia (ozanimod) due to the COVID-19 pandemic.

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Mar. 25

Novacyt’s COVID-19 Test Earns Emergency Use Authorization

The FDA granted Novacyt’s Primerdesign COVID-19 diagnostic an emergency use authorization for use in hospitals and laboratories.

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Mar. 25

FDA Grants Emergency Use Authorization for bioMérieux’s COVID-19 Test

BioMérieux has received an emergency use authorization from the FDA for its Biofire COVID-19 diagnostic for use in certain clinical laboratories.

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Mar. 25

Qiagen Ships Coronavirus Test Kits to U.S.

German devicemaker Qiagen announced that it is sending its QIAstat-Dx coronavirus diagnostic tests to the U.S. after the FDA adopted a new policy to accelerate COVID-19 test availability.

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Mar. 24

Regeneron Finds Hundreds of COVID-19 Antibodies, Says Trials Could Start Soon

Regeneron plans to select the top two antibodies for a cocktail treatment.

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Mar. 24

DiaCarta Earns CE Mark for Coronavirus Test

DiaCarta has received CE Mark certification for its QuantiVirus SARS-CoV-2 diagnostic test validated at its Richmond, California lab.

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Mar. 23

Eli Lilly Delays Most New Clinical Trials

Study participants currently enrolled in Lilly clinical trials should continue following study protocols, the company said.

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Mar. 23

FDA Says No Evidence NSAIDs Aggravate COVID-19 Symptoms

The Medicines and Healthcare Products Regulatory Agency also said Friday that there is currently no research linking ibuprofen to the likelihood of contracting the virus or worsening the symptoms.

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Mar. 23

HHS Gives Liability Cover for Coronavirus Countermeasures

A manufacturer creating a vaccine will be exempt from liability claims alleging negligence.

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Mar. 23

FDA Clears Cepheid’s On-Demand Coronavirus Test for Emergency Use

The test expands the availability of testing and rapid results.

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Mar. 23

FDA Eases REMS Requirements During Coronavirus Outbreak

Sponsors who fail to meet certain Risk Evaluation and Mitigation Strategy (REMS) requirements won’t face FDA action during the COVID-19 outbreak, the agency announced.

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Mar. 23

States Begin Limiting Prescriptions of Potential COVID-19 Treatments

State pharmacy boards in Idaho, Ohio, Nevada and Texas are restricting prescriptions of certain drugs that may hold potential in treating the coronavirus, including chloroquine and hydroxychloroquine, following a spike in demand.

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Mar. 23

COVID-19 Puts Trials on Hold

Dozens of clinical trials are being put on hold as the clinical trial industry grapples with the fallout from COVID-19. The outbreak has put the brakes on virtually all new trials being planned, except those focused on COVID-19 vaccines and treatments.

Read More

View additional COVID-19 news at FDAnews.com and CenterWatch.com

Expert insights on clinical trials and COVID-19

As we navigate COVID-19 together, our clinical trial experts are engaged to address the biggest questions. To submit a topic or question, use the form at the bottom of the page.

Lindsay McNair, MD, MPH, MSB
Chief Medical Officer, WCG

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Mike Cioffi
Senior Vice President, Clinical Solutions and Strategic Partnerships, WCG

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David A. Borasky Jr., MPH, CIP
Vice President, IRB Compliance, WCG

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Janet Wittes, PhD
Founder and President, WCG StatCollab

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Jill Johnston
President, Study Planning and Site Optimization Division, WCG

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David Forster, JD, MA, CIP
Chief Compliance Officer, WCG

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Jonathan Seltzer, MD, MBA, MA, FACC
Chief Scientific Officer, WCG

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Jonathan Zung, PhD
Executive Vice President, WCG

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Suzanne Caruso
Vice President, Clinical Solutions, WCG

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Lori Abrams
Senior Director, Advocacy

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Mark G. A. Opler, PhD, MPH
Chief Research Officer, WCG MedAvante-ProPhase

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Bindi K. Shah, MD
Chief Medical Officer, WCG ACI Clinical

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Stuart Horowitz, PhD, MBA
President, Institutions & Institutional Services

Christopher Randolph, PhD, ABPP-CN
Chief Scientific Officer, WCG MedAvante-ProPhase

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Submit a COVID-19 question or topic to be considered in future webinars

Please note: protocol-specific questions for studies under the oversight of a WCG IRB should be submitted through your IRB contact person, not through this form.

Disclaimer: All information available on this site is intended for your general knowledge and is not for the purpose of providing regulatory advice, medical advice, or a substitute for institutional review board review. You should not use this information to determine compliance with any applicable laws or regulations governing institutional review boards and human subjects research.