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 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

View recent webinars


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.

Schedule a consultation

Insights from October 23

12 Repurposed Agents Are Currently Being Tested For COVID-19 Efficacy

There are 12 agents currently in COVID-19 trials that were originally studied for other conditions and potential uses. Those products are currently in 43 monotherapy and 12 combination COVID-19 trials that have been initiated, and 12 monotherapy and 3 combination trials planned.

 

Multiple Vaccine Technologies Being Studied for COVID-19

An increasing number of vaccines are in clinical trials for the prevention of COVID-19. Some of the vaccines are modifications of platforms that are the basis of previously approved vaccines for other infectious diseases. Others, like the mRNA-based vaccines, are new vaccine technology.


Recent Insights from WCG

Watch Recent COVID-19 Webinars

Site/Sponsor Partnerships in the New Normal – How Sanofi’s SMILE Program Drove the Changes We Need Now

[9/9] Now, more than ever, the partnership between sites and sponsors is essential, as we all navigate the changing site environment and workflows necessitated by COVID-19. With its acclaimed “SMILE” (Sanofi Making Investigator Lives Easier) program, Sanofi led the industry in building up those critical partnerships in 2019. Now, in mid-2020, resumption of clinical research comes with new considerations for on-site safety and screening requirements, new technologies and operating models, and new financial and logistical considerations. Building strong, transparent relationships between sites and sponsors will be critical to determining balance in everything from protocol requirements, funding, new tools and engagement strategies, and secure data collection in this new era. What can we all learn from Sanofi’s efforts? In this webinar, we will:

  • Hear how Sanofi’s renowned SMILE initiative has eased burden on clinical trial sites since its launch in 2019 and helped sites address challenges arising from the COVID-19 pandemic
  • Talk with LMC Manna Research about needs and expectations from sponsor partnerships in this new era and how its involvement in Sanofi’s external advisory committee helped shape the design, approach and solutions of the SMILE program
  • Discuss how sites and sponsors can practically align to manage peaks in activity and set a new standard for processes and resources
 

The True Problem of COVID-19 Misinformation: How the Spread of Inaccurate Information Harms our Progress toward New Therapies

[8/19]The problem of the spread of scientific misinformation is very real. We’ve probably all seen stories on social media about COVID-19, or anonymous testimonies from alleged healthcare providers, some of which seem obviously untrue. But we can’t dismiss the impact that misinformation is having on our ability to combat COVID-19, in terms of mistrust of the scientific community, resistance to following COVID-19 precautions, hesitancy to participate in clinical trials and predicted concerns about wide-spread agreement to COVID-19 vaccine use. In this webinar, the speakers will:

  • Discuss a recent study looking at how willing people are to share COVID-19 news on social media, and the intervention that reduced the spread of false information
  • Consider how misinformation about clinical trials, treatments and vaccines disproportionally impacts minority communities, including willingness to participate in research and seek treatment
  • Provide suggestions for how our clinical research community can help to stop the spread of misinformation
 

COVID-19 Ethics: Looking at Scientific Data Dissemination, Vaccine Development and Access to New Therapies Through an Ethical Lens

[8/5] The COVID-19 pandemic has brought accessibility to scientific and clinical trial data and information to the general public. But with this eagerness for scientists to share and for media to amplify new information, sometimes even before it has been vetted by other scientists, we also have ethical challenges. In this webinar, our expert bioethicist guests will discuss:

  • The complex ethical questions of the quickly evolving COVID-19 vaccine development landscape
  • How the rush to quickly share scientific information can potentially disrupt progress in clinical trials, and create a minefield for front-line healthcare providers
  • That this unprecedented access to information creates a tsunami of demand for access to unapproved and sometimes barely tested potential therapies and the regulatory system designed to manage that process
 

 

 

Clinical Trials Transformation & Easing the Patient Burden – How COVID-19 is Moving Us Into A Future Where Trials Are More Accessible and Convenient

[7/22] There is so much discussion going on across all of clinical research – operations, regulatory, compliance and patient advocacy as it relates to how we’re all handling the COVID-19 environment. We’ve seen adaptations to telemedicine, shipping study drugs to participants, remote endpoint assessments and laboratory testing collected locally or at home. But how many of those changes will stick when the “new normal” comes? The changes that allowed studies to continue through COVID are many of the ones that patients have been asking for to decrease participant burden and expense, and to make trial participation available to a broader and more diverse population. In this webinar, we’ll discuss:

  • Was this the shock that will finally lead to change?
  • Why are these changes to study conduct so important to participants?
  • How can biopharma sponsors use what was learned to make important and lasting changes?
 

Conducting Research at Institutions Post-COVID-19 – Exploring New Norms in the Conduct of Sponsored Clinical Research

[7/8] The resumption of Clinical Research is underway, with new precautions and procedures in place for the protection of research participants and research staff. As institutions resume clinical research and initiate new clinical trials, there is growing stress on the internal resources necessary to support key study-related activities for both COVID-19 and non-COVID-19 trials – including data entry, monitoring, and patient enrollment and engagement. There is growing concern that sites, CRAs and other critical resources will be unable to absorb the volume of work required in the short-term to make up for lost time.

In this webinar, we will:

  • Provide insights around what the clinical research world is doing to expeditiously resume studies that were paused, and start initiation of delayed studies
  • Understand how external resources can be leveraged by clinical sites to get back to research-readiness, given resource constraints
  • Learn how sites are preparing to manage the bolus of monitoring and study activities that will hit as research resumes
 

COVID-19 Changed Everything – Now Contracts and Budgets Need to Catch Up

[6/24] As clinical trials shift quickly and necessarily from in-person to hybrid trials, remote visits, and virtual experiences and support, new opportunities and challenges emerge. While the industry figures out how to best navigate these new challenges, and much remains unresolved, we do know this: Sites and sponsors will be recalibrating everything, especially contract terms and budgets for either new components of trials or changes to clinical research. Site budgets for ongoing studies will need to be recalculated, amended and renegotiated, and contracts and budgets for new studies will have new considerations. In this webinar, we’ll explore:

  • How sponsors and sites are managing revisions of agreements for existing studies where visits, tasks and activities have changed
  • What sponsors and sites are thinking about with regard to new COVID-19-related expenses and contracting requirements (e.g., coverage of site-mandated COVID-19 screening or required PPE)
  • How to build flexibility into contracts and budgets so that significant shifts in study conduct can be managed without requiring major revisions to budget or legal terms
 

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

Download Key Takeaways

[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

Download Key Takeaways

[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

Download Key Takeaways

[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

Download Key Takeaways

[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

Download Key Takeaways

[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

Download Key Takeaways

[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

Download Key Takeaways

[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

Download Key Takeaways

[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

Download Key Takeaways

[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

Download Key Takeaways

[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

Download Key Takeaways

[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

Download Key Takeaways

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

Oct 23

Gilead’s Remdesivir Gains Full FDA Approval for COVID-19

The FDA on Thursday granted full approval to Gilead Sciences’ Veklury (remdesivir) to treat hospitalized COVID-19 patients, making it the first approved COVID-19 treatment in the U.S.

Read more

Oct 23

AstraZeneca’s COVID-19 Vaccine Delivers Strong Immune Response, Study Confirms

AstraZeneca’s COVID-19 vaccine candidate, AZD1222, currently being evaluated in phase 3 global trials, delivers a strong immune response, according to a new UK study.

Read more

Oct 23

In Ongoing Hahn-Azar Feud, Azar Denies Plotting Hahn’s Ouster

HHS Secretary Alex Azar denies a report that he and colleagues are plotting the ouster of FDA Commissioner Stephen Hahn over Hahn’s holding fast to stricter, more time-consuming rules for makers of novel COVID-19 vaccines than what the White House wants.

Read more

Oct 23

FDA Vaccines Advisory Committee Reviews EUA Requirements, Postmarket Studies

The FDA’s Vaccines and Related Biological Products Advisory Committee took no action Thursday after a lengthy discussion of the agency’s COVID-19 vaccine requirements, considerations for continuing blinded phase 3 trials after an Emergency Use Authorization (EUA) is issued and postmarket studies.

Read more

Oct 23

New Report Sounds Alarm on Pandemic-Induced Drug Shortages

The COVID-19 pandemic is worsening a pre-existing problem of drug shortages in the U.S., University of Minnesota researchers report in a new analysis.

Read more

Oct 23

Moderna Finalizes Enrollment for Phase 3 COVID-19 Vaccine Trial

CEO Stéphane Bancel said the company’s COVID-19 vaccine won’t be available for widespread distribution until Spring 2021.

Read more

Oct 23

Roche Forges Deal With Atea for COVID-19 Antiviral Pill

The drug works by interfering with the viral RNA polymerase, responsible for replication.

Read more

Oct 22

Researchers Urge Greater Transparency for Government-Funded Vaccine Trials

More than two dozen researchers and experts have penned a letter to HHS Secretary Alex Azar, National Institutes of Health (NIH) officials and pharma company executives, imploring them to shed more light on the clinical trial designs for federally funded COVID-19 vaccine studies.

Read more

Oct 22

Brazil’s President Bolsonaro Says No Deal With Sinovac for COVID-19 Vaccine

Brazil’s President Jair Bolsonaro announced Wednesday that his government will not purchase a COVID-19 vaccine developed by Beijing-based Sinovac, just one day after the country’s health minister announced it would be placing an order.

Read more

Oct 22

EU Finalizes Deal With J&J for 400 Million Doses of COVID-19 Vaccine

Johnson & Johnson has finalized a deal with the European Commission for 400 million doses of its COVID-19 vaccine candidate, Ad26.COV2.S.

Read more

Oct 22

Brazilian Regulator Announces Patient Death in AstraZeneca Vaccine Trial

Brazil’s health regulator ANVISA (Agência Nacional de Vigilância Sanitária) disclosed Wednesday that a participant had died in AstraZeneca’s Brazilian late-stage COVID-19 vaccine trial, though the UK drugmaker said the incident was not grounds for stopping the study.

Read more

Oct 22

California Will Independently Verify COVID-19 Vaccine

California Governor Gavin Newsom has named an 11-person scientific review panel to verify the safety of any FDA-approved COVID-19 vaccine before it is distributed in the state.

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

View Bio

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

View Bio

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

View Bio

Janet Wittes, PhD
Founder and President, WCG StatCollab

View Bio

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

View Bio

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

View Bio

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

View Bio

Jonathan Zung, PhD
Executive Vice President, WCG

View Bio

Suzanne Caruso
Vice President, Clinical Solutions, WCG

View Bio

Lori Abrams
Senior Director, Advocacy

View Bio

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

View Bio

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

View Bio

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

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

View Bio

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.