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.

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COVID-19 Clinical Trial Tracker

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

WCG COVID-19 Trial Matching Tracker

67

investigators matched to sponsors
for participation in COVID-19 trials

Participate in WCG’s COVID-19 Trial Matching Service:

COVID-19 Trial Matching for Institutions

COVID-19 Trial Matching for Sponsors


COVID-19 Trial Insights from the WCG Knowledge Base™

About WCG Trial Insights

The WCG Trial Insights series brings you weekly insights on trial activity throughout the COVID-19 crisis, based on the extensive services we provide to life science clients and supported by our proprietary and powerful WCG Knowledge Base™.

See all COVID-19 data analysis

WCG COVID-19 Advisory Services

Need help interpreting critical data to navigate the impact of COVID-19 on trials and sites? We leverage insights and benchmark data from the WCG Knowledge Base to guide best practices for trial performance during this unprecedented time.

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Insights from May 22

New Enrollment Recovery Continues, With 21% of Sites Now Open to Enrollment

WCG is tracking more than 1,400 sites in 29 countries to understand how quickly total trial enrollment is being affected during this pandemic. The four countries showing the largest amount of clinical trial restart activity in the past week are the U.S., Israel, Poland and Ukraine.

21% of sites are now open to enrollment of new participants, an increase of 10 percentage points in the last three weeks. We anticipate this trend to continue as countries reopen.

Global Investigator Restarts Focused on Ongoing Trials

Investigator restart comes in two forms – being open to enrollment of ongoing studies, and being open to enrollment of both ongoing and new trials. Very early data show that of the global sites that are restarting enrollment activity, 37% are open only to restarting ongoing trials, while 57% are open to enrollment of ongoing and new trials. 6% of sites are only open to new trials at this time.

That means that more than a third of investigators are still not willing to take on new trials that have been waiting to start since the COVID-19 outbreak. We will have more information on this next week.

Investigators Starting Trials in the U.S. Down Almost 50% in the Last 30 Day

New investigators study starts are down an average of 45.6% across the U.S., based on a comparison of investigator study starts from January 15 to February 15, versus starts in last 30 days.


Recent Insights from WCG

Watch Recent COVID-19 Webinars

Part 10: Unique Challenges and Opportunities for Emerging Biopharma Companies with Focused Pipelines

[5/20] In this webinar, we turn our focus to the challenges unique to our innovative colleagues in the emerging biopharma space. With smaller and focused-pipeline organizations making up over 50% of clinical trials activity pre-COVID-19, these sponsors represent the potential for enormous advances in development, but also shoulder the challenges of keeping projects moving in highly concentrated pipelines during this time. Our expert speakers discuss:

  • How the agile nature of emerging biopharma has uniquely enabled them to pivot quickly and map to new methodologies to sustain and manage ongoing trials during the pandemic
  • How organizations with focused pipelines or single assets are facing development and commercial realities going forward

We’ll speak with leaders from emerging biopharma organizations with assets in different therapeutic areas and in various phases of development and commercialization; and about the evolving resources that address biopharma needs during this time.

 

 

Part 9: The Challenges of Developing Vaccines and Treatments for COVID-19

[5/13] In this webinar, our expert speakers turn their attention to challenges of doing research on the COVID-19 pandemic. They discuss:

  • The remdesivir development pathway and the experience of designing and conducting clinical trials in a brand-new disease without the benefit of medical guidance or regulatory precedent
  • The status and future of prophylactic vaccine development for COVID-19
  • The ethical issues of human challenge studies, which can speed vaccine development timelines but require careful consideration because they would intentionally expose study volunteers to COVID-19
 

 

Part 8: The Realities of Restart

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[5/6] In this webinar, we turned our focus to the realities of restarting clinical trials by examining WCG data spanning the clinical trials ecosystem. We talked to leaders at research sites to understand their key issues and we’re helping sponsors understand what they should be aware of as they prepare to re-engage. We speak with our expert panel about the following:

  • WCG is evaluating data and trends based on a panoramic view of the clinical trials ecosystem and supported by our proprietary WCG Knowledge Base™ decision engine. We will highlight critical data points and share what today’s trends are telling us about what to expect next.
  • From there, we’ll transition to on-the-ground perspective from sites about the challenges, concerns and opportunities posed by this moment.
  • Finally, we’ll consider how those challenges translate into readiness considerations for sponsors and CROs.
 

Part 7: Imagining the Future State of Clinical Research

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[4/29] In this webinar, our expert, Ken Getz of Tufts CSDD, explores 3 facets of this transitional period:

  • What the clinical research world was really like in 2019, by drawing from the rich data of the Tufts Center for the Study of Drug Development (CSDD).
  • What the clinical research world may look like in 2021 and beyond, and the potential changes to the ways we design protocols, select clinical sites, and operationalize studies.
  • Whether the public discussion of the development of COVID-19 therapies could potentially be a turning point in the public’s understanding, awareness and engagement with clinical trials.
 

Part 6: Going Remote During COVID-19: Considerations When Moving Studies Out of the Clinic Setting

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[4/22] In this webinar, our panel of experts discuss what you need to know about the impact of COVID-19 on your clinical trials:

  • Informed consent: what’s allowed and what’s practical in obtaining consent remotely, where does electronic consent come in, and whether participant compensation needs to be modified
  • How do IRBs consider the review of “virtual” clinical trials?
  • What do sponsors consider when deciding whether study visits can be conducted remotely, both when planning ahead, and when reacting to urgent issues?
 

Part 5: Maintaining Data Collection and Data Validity Amidst Major Study Changes

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[4/15] In this webinar, our panel of experts discuss what you need to know about the impact of COVID-19 on your clinical trials:

  • How do you continue to collect data and preserve your study?
  • Considerations for your endpoints; are your outcome measures still valid if you go remote?
  • What is the impact on interpretation of outcomes; can you combine pre-event and post-event data and baselines?
 

Part 4: Planning for Recovery: How Research Sponsors and Research Sites are Thinking Ahead to Restart Research

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[4/8] Our panel of experts discuss what you need to know about the impact of COVID-19 on your clinical trials:

  • What are sponsors doing now to plan ahead and to position studies to return to full activity as precautions release?
  • How can sites prepare for the wave of study restarts? What can be done now- even remotely- to maintain contact with participants, sponsors and vendors?
  • What will be different about our research studies, procedures and practices as we move into a post-COVID world?
 

Part 3: Evaluating Study Status and Leveraging Data Monitoring Committees to Make Study Decisions

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[4/1] Our panelists discuss best practices for:

  • Evaluating whether there is enough reliable data to draw meaningful clinical study conclusions
  • Assessing the status of each clinical study – what challenges and opportunities are presented based on study characteristics and timeline?
  • Determining how studies can be designed now to build in future flexibility in schedules, procedures and analysis plans
  • Leveraging DMCs/DSMBs to play a role in the assessment and modification of studies
  • Revisiting safety data collection and reporting during the COVID-19 crisis
 

Part 2: The Necessary Changes that Sites, Institutions and Research Participants are Considering During the COVID-19 Crisis

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[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

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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 news on COVID-19 and clinical trials

News provided by WCG FDAnews and WCG CenterWatch

May 26

Full NIH Data on Remdesivir Supports Early Positive Report

NIH Friday confirmed preliminary remdesivir trial data showing that the drug delivered a median recovery time of 11 days compared with 15 on placebo, establishing it as the standard of care for patients with moderate to severe disease.

Read more

May 26

CanSino Biologics’ COVID-19 Vaccine Shows Promise in Humans

A leading COVID-19 vaccine candidate has shown promise as being safe and effective in humans and produced an immune response against the coronavirus, according to preliminary data from a phase 1 trial of 108 healthy adults in China.

Read more

May 26

Large Study Links Hydroxychloroquine to Increased Risk of Death

Another study — the largest to date — has shown that anti-malaria drugs hydroxychloroquine and chloroquine have no benefit in treating COVID-19, in fact have a negative effect on patient survival and are associated with an increase in ventricular arrhythmias.

Read more

May 26

STERIS Gets Emergency Use Authorization for Steam Sterilizer

Currently, there are no FDA-approved devices for decontaminating N95 respirators.

Read more

May 26

New Reagent Available to Support COVID-19 Diagnostics

The reagent contains coronavirus genetic material used to confirm that a test is working correctly.

Read more

May 26

IMV Selects COVID-19 Vaccine Candidate for Human Trials

IMV expects to initiate a phase 1 trial testing the vaccine in 84 healthy volunteers this summer.

Read more

May 22

Large Hydroxychloroquine Study Gets Under Way

Enrollment for a large, global trial of chloroquine and hydroxychloroquine for the prevention of COVID-19 is getting under way in the United Kingdom.

Read more

May 22

TriNetX, Harvard Pilgrim Health Care Institute to Monitor COVID-19 Drug Usage

TriNetX is partnering with the FDA’s Sentinel Operations Center at the Harvard Pilgrim Health Care Institute (HPHCI) to monitor priority drugs used for treating hospitalized COVID-19 patients.

Read more

May 22

FDA Adds Morphine, Epinephrine to COVID-19 Compounding List

The FDA added morphine sulfate and epinephrine to the list of compounded drugs under the agency’s temporary policy that allows outsourcing facilities to produce the drugs during the COVID-19 pandemic.

Read more

May 22

AstraZeneca Receives $1.2 Billion BARDA Contract for COVID-19 Vaccine

AstraZeneca has nabbed an HHS contract worth up to $1.2 billion to speed development and production of the University of Oxford’s promising COVID-19 vaccine candidate. The deal also would lock in the distribution of 300 million doses of the vaccine for the U.S.

Read more

May 22

BioMérieux’s COVID-19 Antibody Tests Obtain CE Mark

The presence of antibodies in a patient means that they likely had COVID-19 at some point and may suggest they have some degree of immunity.

Read more

May 22

Fujifilm Begins Research on AI Tech for COVID-19 Pneumonia

The company is involving local Japanese medical institutions in its project, beginning with Yokohama’s Kanagawa Cardiovascular and Respiratory Center.

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.