2020 in Review: Celebrating the Successes of the Clinical Research Community After A Difficult Year

[12/2] This past year, impacted so greatly by the COVID-19 pandemic, has been a difficult year for the clinical research community. But we’ve also seen the pressures of the past year translated into remarkable achievements in how we design and conduct clinical trials. In this webinar, we’ll review what happened in 2020, and look at some of the metrics. Several of WCG’s clinical research experts will also talk about the changes they saw across different parts of the clinical research ecosystem in 2020, how the stressors brought about positive changes, and why they are optimistic about the future as we move into 2021.

Statistical Concepts in COVID-19 Clinical Studies: Understanding the Design of, and Data from, Randomized Trials

[11/18] The public is more aware than ever of randomized clinical trials because of the news about therapies and vaccines for COVID-19. Details of study design, conduct of trials, and interpretation of data are in the daily news. Prior to COVID-19, when would we see the timing of interim analyses discussed so broadly? In fact, when we would even hear the words “interim analysis”? This public discussion has made many people who are not usually involved in the statistical details of trial design more curious about how these concepts and practices work. In this webinar, Dr. Janet Wittes, an internationally recognized expert in the statistics of drug development, will answer questions many people are asking themselves:

• The study question: Can we look at several different outcomes in a single clinical trial?
• What are interim analyses?
  • What are “stopping rules” and how can they protect the safety of participants?
  • Why can’t investigators look at the data during the trial? And who does look at ongoing data?
  • What does “stopping for futility” and “stopping for overwhelming efficacy” mean?
• If a vaccine study randomizes tens of thousands of people, how can it declare “overwhelming efficacy” with fewer than 40 cases of COVID-19?

Focusing on Safety: Challenges in the Interpretation and Communication of Clinical Safety Reports – and How Technology Can Help

[11/4] With so much attention focused on the development of therapies and vaccines for COVID-19, the details of clinical trial design and conduct – including the reporting and interpretation of safety data – are suddenly a topic of public discussion. While there are regulatory structures around the collection of safety data in clinical trials, the interpretation of that data can be challenging. How do you assess the relationship of an event to a study drug when the data are still blinded? How do you look at adverse events that turn out to have been in people taking a placebo? How do you communicate the safety information in an ongoing study to all the investigators in a way that is informative but not overwhelming – especially in extremely large studies?

In this webinar, experts in clinical safety and safety data technology will join us to talk about both the art and the science of interpreting clinical safety information and about improving the way we communicate safety information.

• How are safety data collected and who is looking at that data to protect the research participants?
• What are the challenges of interpreting safety data in clinical trials?
• How can technology be used to facilitate the communication of safety information to study sites and oversight agencies especially in large and multi-national studies?

How to Generate Reliable Clinical Trial Results: An Increasing Challenge in the COVID Era

[10/21] Current regulatory guidance requires that sponsors ensure the reliability of data generated by clinical trials. Yet, the concept of reliability is not defined in these guidance documents, nor is it made clear how to determine whether reliability has been achieved. The concepts of accuracy and reliability in other arenas of measurement science have been well-defined – and these concepts can be applied to clinical trials, to drive the reliability of critical processes and measurement activities within the trial. Unfortunately, during the COVID-19 crisis problems in critical processes that can impact study results are more likely- and require even greater attention than before, particularly where study endpoints are subjective.

In this presentation, Dr. Nathaniel Katz, WCG’s Analgesic Solutions Chief Scientific Officer and expert on clinical research methodology and former FDA Advisory Committee chair, will present a systematic approach to evaluating and ensuring reliability of data in clinical trials, including:

• Defining the concepts of accuracy and reliability of clinical trial data
• Determining what drives reliability
• Presenting evidence-based options for ensuring trial data reliability
• Discussing several considerations regarding the relationship between the COVID pandemic and trial reliability, including new threats to clinical data reliability and the need to protect the reliability of subjective endpoints in clinical trials of treatments for COVID-19

COVID-19 and ‘Pandemic Exceptionalism’: The Tension Between Taking Quick Action and Collecting Data in Urgent Medical Settings

[10/7] Early in the COVID-19 pandemic, a series of basic and important clinical questions arose regarding the repurposing of available therapies (such as hydroxychloroquine and tocilizumab), the use of convalescent plasma, and the value of different approaches to supportive care. The US healthcare system has a large, pre-existing research infrastructure, enormous financial investments, and the world’s largest COVID-19 outbreak, yet has failed to clearly answer many of these questions.

In this webinar, Dr. Jonathan Casey, an intensivist and clinical trialist with an expertise in comparative effectiveness research and experience leading clinical trials for COVID-19, will discuss the complex topic of clinical research in urgent medical settings, including:

• The need to avoid pandemic exceptionalism, which is the idea that our usual standards of science and evidence-based medicine don’t apply in a pandemic setting
• The rapid adoption of unproven therapies such as hydroxychloroquine and convalescent plasma as treatments, and the ethical and clinical controversies that emerged as controlled clinical trials added to our collective knowledge
• Considering a learning healthcare system as a model for more rapid and efficient generation of knowledge in the future.

Diversifying Clinical Trial Participation: Effective Strategies for Identifying and Recruiting Diverse Patient Participants

[9/23] To ensure that approved medications benefit all populations, it is essential that the participant population in clinical trials represent the applicable patient population. But ethnic and racial minorities continue to be systematically underrepresented in clinical research. As this issue is finally being recognized and discussed, sponsors and sites are looking for ways to ensure appropriately diverse enrollment into clinical trials. In this webinar, speakers will discuss:

• How do we do a better job bringing awareness and accessibility about clinical trials to a diverse racial/ethnic patient population?
• What are some specific, concrete ideas that can be employed to increase enrollment of diverse participant populations?
• How will the increasing role of mobile data collection tools impact the diversity of clinical trial populations as we adjust to the “new normal” of clinical trials post- COVID-19?

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

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[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

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[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