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 29

Active COVID-19 Trial Starts Hit 1,450 as 60% of Countries See an Increase in Pace of New Cases

More than 1,450 COVID-19 trials have been started in 2020, as the global number of COVID-19 cases reported tops 5.5 million. Of the 139 countries being tracked, 60% have more new cases reported in the last 5 days than in the prior 6-10 days… and those are just for the countries reporting case counts.

Enrollment Recovery Continues, With 23% 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. 23% of sites are now open to enrollment of new participants – another 2 percentage point increase in the past week.

Serious Adverse Event Reaction Reporting Continues to Drop

WCG has detected a 30% drop in both unexpected and expected serious adverse reaction reports between February and April among the pharmaceutical companies and CROs using WCG SafetyPortal. That indicates a slowdown in patient visits since the start of the COVID-19 lockdown. Reporting initially fell 23% from March to April, then an additional seven percentage points by the end of April.


Recent Insights from WCG

Watch Recent COVID-19 Webinars

PART 12: Public awareness of clinical research and the path to diversity in clinical trials

[6/3] COVID-19 and the effort to develop treatments and vaccines for COVID-19 have brought awareness of clinical trials into the public view like never before. What impact is that discussion having on the public’s understanding of clinical trials as part of the drug development process? In addition, there’s been extensive conversation about ensuring COVID-19 treatment studies include an appropriately representative population. How can we advance this important discussion to achieve diversity in research study enrollment?

In this webinar we:

  • Review a recent CISCRP survey examining how COVID-19 has affected awareness, perceptions and understanding of clinical research for the general public
  • Discuss how future understanding of and participation in clinical research may be affected by the pandemic
  • Review the disproportionate impact that COVID-19 is having on minority communities in the U.S. and discuss the need to ensure appropriate representation in COVID-19 clinical trials
 

PART 11: The Impact of COVID-19 on Oncology Research – Immediate and Long-term Effects

[5/27] More clinical trials are conducted for cancer than for other therapeutic areas, and these trials often include participants who have exhausted the available treatment options. So when COVID-19 forced a re-assessment of ongoing and upcoming studies, patients and care providers were placed in a difficult situation. We’ll talk to a leading cancer researcher and a patient who was in screening for a new clinical trial, about the present and future of oncology clinical trials.

Our expert speakers discuss:

  • How did cancer research centers react to COVID-19 and make decisions about continuing or pausing clinical trials, and what are they planning for the near future?
  • What kind of long-term effects might we see in the design and conduct of oncology clinical trials as a result of COVID-19?
  • The patient perspective: How it feels to get the call that your cancer clinical trial has been put on indefinite hold
 

 

 

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

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[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

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[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

Jun 4

Researchers Study Cardiovascular Drugs for COVID-19 Patients

Several common cardiovascular drugs are being studied as potential COVID-19 treatments, with early findings suggesting they pose no increased risks for patients taking them regularly.

Read more

Jun 4

Administration Targets Five Vaccine Candidates Under Operation Warp Speed

The Trump administration has reportedly selected five COVID-19 vaccine candidates from a list of 14 to be evaluated under Operation Warp Speed. The five frontrunners are being developed by Moderna, Johnson & Johnson, AstraZeneca, Merck and Pfizer.

Read more

Jun 4

Hydroxychloroquine Ineffective for Preventing COVID-19, U of M Study Finds

The University of Minnesota has published results from its COVID-19 hydroxychloroquine trial that show the anti-malaria drug is ineffective at preventing coronavirus infection, echoing negative results from other recent studies.

Read more

Jun 4

Leading Medical Journals Question Data From COVID-19 Studies

Two respected medical journals have raised questions about the reliability of data provided by a controversial data analytics company in two different trials done for two COVID-19 treatments.

Read more

Jun 4

UK Researchers Test Ibuprofen Formulation as COVID-19 Treatment

Researchers in the UK are launching a clinical trial to test a unique formulation of ibuprofen for treatment of severe acute respiratory distress syndrome (ARDS) in COVID-19 patients.

Read more

Jun 4

Novavax Partners With AGC Biologics to Manufacture COVID-19 Vaccine Component

AGC Biologics will scale up production of the adjuvant to help increase Novavax’s capacity to deliver vaccine doses this year.

Read more

Jun 4

UK Halts Sales of Fingerprick COVID-19 Antibody Tests

Purchasers who received an antibody test result should not consider the result to be reliable, the agency said.

Read more

Jun 3

Drugmakers Report Zoloft Shortage Amid COVID-19

Makers of Zoloft (sertraline hydrochloride) and its generic versions are reporting shortages linked to increased demand during the pandemic coupled with supply chain issues caused by the impact of COVID-19 on manufacturers of active pharmaceutical ingredients (APIs).

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Jun 3

Lawmakers Outraged Over Ineffectiveness of FDA’s Foreign Inspections Program

Federal lawmakers yesterday criticized the effectiveness of the FDA’s foreign inspections program, expressing outrage that the controversial anti-malaria drug hydroxychloroquine, which has been used to combat COVID-19, came from foreign plants that have never been inspected.

Read more

Jun 3

Hahn Predicts Permanent Changes at FDA Because of COVID-19

The FDA’s changes in response to the COVID-19 outbreak will lead to permanent improvements at the agency, predicts FDA Commissioner Stephen Hahn.

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Jun 3

BerGenBio Doses First COVID-19 Patient With Bemcentinib in UK ACCORD Initiative

BerGenBio has announced that the first COVID-19 patient was dosed with bemcentinib in a phase 2 trial to evaluate the drug as a potential treatment.

Read more

Jun 3

Celltrion’s COVID-19 Antiviral Shows Positive Results in Pre-Clinical Studies

The company plans to begin human clinical trials next month.

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.