Explorez tous les épisodes du podcast WCG Talks Trials

 Study start-up remains one of the most persistent bottlenecks in clinical trials—slowing site activation, delaying patient enrollment, and adding pressure across already stretched teams. In this episode of WCG Talks Trials, host Jamie Harper, Vice President of Site Solutions & Engagement at WCG, is joined by Stephanie Held, Associate Director of Coverage Analysis, and Jody Ingebritsen‑Howe, Director of Contracts & Budgets, to unpack why start-up timelines continue to stall and what can be done to improve them.

Together, they explore how Medicare Coverage Analysis (MCA) serves as the foundation for compliant and efficient study start-up, how downstream processes like budgeting, contract negotiations, and CTMS build are impacted by early decisions, and where “hidden” white space can quietly derail timelines.

The conversation also highlights practical, actionable steps sites and sponsors can take today—from mapping end‑to‑end workflows to better equipping negotiators with the information they need.

Looking ahead, the panel discusses how technology and AI may reshape study activation, while emphasizing the importance of human expertise and alignment across teams. Whether you’re a site, sponsor, or CRO, this episode offers timely insights to help accelerate activation and reduce friction in an increasingly complex trial landscape.

Host:

Jamie Harper, vice president, Site Solutions & Engagement

Guests:

Stephanie Held, associate director, Coverage Analysis

Jody Ingebritsen-Howe, director, Contracts & Budgets

Clinical trial complexity is rising with more procedures, endpoints, and technology, yet sites are turning these pressures into pathways for improvement. In this episode of WCG Talks Trials, host Jenna Goeller sits down with Trevor Cole to unpack practical ways research sites sustain readiness, build resilience, and spark innovation amid frequent protocol amendments and technology overload. Together, they explore what’s changing on the ground and how sites are responding with stronger feasibility reviews, capacity planning, streamlined protocol advocacy, and risk‑proportionate oversight – all grounded in Quality by Design and the updated ICH E6(R3) guidance.

Listeners will hear data‑driven insights on:

• The operational ripple effects of complexity, including resource strain, rework from amendments, and tech support burdens, and what’s working to reduce them.
• Day‑to‑day applications of risk‑based quality management, data governance, and proportionality to protect participant safety and data integrity.
• Culture and maturity for empowering teams, mapping processes before SOPs, continuous training, Correction and Preventive Action (CAPA) discipline, and knowledge sharing across silos.
• How sponsors and CROs can better support sites through integrated technology, protocol simplification, early collaboration, and transparent communications.
• Turning complexity into growth by investing in people and processes, using fit‑for‑purpose tech (including selective AI use), and engaging local communities.

Speakers:

Jenna Goeller, Associate Director, Clinical Trial Insights & Analytics, WCG

Trevor Cole, Program Director, Clinical Solutions & Partnering, WCG

In this episode of WCG Talks Trials, host Gabriella Tost sits down with Latin America regional experts Mercedes Lopez, Camila Santos, and Sebastian Florez to explore how artificial intelligence, telemedicine, and wearable technologies are reshaping clinical research across Latin America. From expanding access through virtual care to empowering patients with biosensors, the conversation highlights how digital tools are breaking longstanding barriers to participation — especially for rural and underserved communities. 

The group dives into the growing role of AI in participant identification, site selection, and overcoming fragmented health records — challenges historically unique to the region. They also discuss rapid regulatory modernization in countries like Brazil, Mexico, and Ecuador, which is accelerating approvals, enabling decentralized trials, and fostering a fertile environment for global investment. 

Looking ahead, the experts paint an exciting picture of what research will look like by 2026: connected data ecosystems, hybrid study models, stronger community engagement, and more inclusive recruitment than ever before. Whether you're a sponsor, site, or technology innovator, this episode offers clear insights into why Latin America is becoming a global leader in digital-forward, participant-centered clinical trials. 

For more into these insights, read their article, “AI and the Digital Future of Health in Latin America: A Sponsor's Opportunity,” in the 2026 Trends & Insights Report.  

In this episode of WCG Talks Trials, Sandy Smith, Sylvia Baedorf Kassis, and Dr. Donna Snyder discuss the critical role of health literacy in clinical research. They explore how clear communication can enhance patient understanding and engagement, the importance of a common language in research, and the introduction of the MRCT Center’s Clinical Research Glossary as a tool to facilitate better communication. The conversation emphasizes the need for consistent terminology and the integration of health literacy practices in clinical research to improve participant experiences and outcomes.

Key highlights:

• Health literacy is crucial for effective communication and participant engagement in clinical research.
• The MRCT Center’s Clinical Research Glossary helps simplify complex terms into plain language, supporting understanding for all stakeholders.
• Consistent terminology and clear communication empower participants, improve data accuracy, and enhance patient advocacy.
• Integrating health literacy practices leads to better retention and experiences for trial participants.

Host:

Sandy Smith, RN, MSN, AOCN, senior vice president, clinical solutions & strategic partnering, WCG

Guests:

Sylvia Baedorf Kassis, MPH, program director, Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

Donna Snyder, MD, MBE, executive physician, WCG

In this episode of WCG Talks Trials, Cristin MacDonald, Doug Mayer, and Tyler Bye discuss how Software as a Service (SaaS) solutions are democratizing the clinical trial landscape. Learn how SaaS platforms are enabling organizations of all sizes to leverage cutting-edge technology, improving collaboration, standardization, and data security throughout the clinical research process. The team shares the benefits of adopting SaaS, practical insights for successful implementation, and highlights the pivotal role of technology partnerships in supporting innovation and research efficiency. Tune in to discover how your organization can optimize clinical trials and accelerate research impact with SaaS technology.

In this episode of WCG Talks Trials, Silvio Galea, chief data and analytics officer, and Bryan Wayne, vice president of imaging operations, both of WCG, explore the critical role of imaging in clinical trials. Together, they break down industry acronyms, unpack the process of independent image review, and discuss how WCG is contributing to the validation and implementation of AI-driven radiology solutions. Listen in as they share behind-the-scenes insights into core lab operations, the significance of sample size and study design, and how emerging technology is shaping the future of clinical research. Whether you are a clinical trial professional, healthcare innovator, or simply curious about the intersection of AI and research, this episode provides valuable perspectives on driving efficiency, accuracy, and better outcomes in clinical research imaging. 

For more information about WCG’s imaging solutions, visit wcgclinical.com/imaging.  

In this episode of WCG Talks Trials, Sandy Smith, senior vice president, clinical solutions & strategic partnering, WCG, is joined by Tiffany Pierce, director, clinical trials core, Henry Ford Health System, to discuss resilience in clinical research.

As the landscape of clinical trials faces evolving challenges, they explore how organizations and institutions, like Henry Ford Health, are addressing disruptions, uncertainties, and changes at the federal level. Learn about innovative strategies to enhance trial efficiency, including role clarity, flexible workflows, and diversifying research portfolios.

With a focus on maintaining forward momentum in trials and remaining nimble, they discuss actionable solutions to administrative burdens and enhance the efficiency and speed of trial completion. This episode offers invaluable guidance for professionals seeking to stay agile and adapt to ongoing changes in the clinical trials. 

HOST: Sandy Smith

SPEAKER: Tiffany Pearce

Dive into the world of generative AI with Silvio Galea, chief data analytics officer, WCG, and Kyle Miller, lead data scientist, WCG. In this compelling episode of WCG Talks Trials, we explore how Generative AI can improve clinical research workflows from meticulous data entry to efficient data validation. Uncover the technology behind AI’s ability to assist in document updates, highlight transcription biases, and digitize complex data for predictive analytics. Understand the importance of human oversight and practical applications that can optimize how clinical trials are conducted. Whether you’re curious about AI’s role in reading dense documents or leveraging pipelines for innovation, this episode provides the insights you need.

Guests:

Silvio Galea, chief data and analytics officer, WCG

Kyle Miller, lead data scientist, WCG

In this episode of WCG Talks Trials, join Silvio Galea, chief data and analytics officer, WCG, and Melissa Hutchens, vice president of research and benchmarking, WCG, as they discuss the transformative role of AI in clinical trials. Discover how generative AI and other AI technologies are enhancing the quality of clinical trials, reducing cycle times, and cutting costs. The episode covers the benefits, barriers, and concerns associated with AI, and explores its applications in drug discovery, participant recruitment, trial design, and more. Tune in to learn about the latest advancements in AI and how they are shaping the future of clinical trials.  

Guests: 

• Silvio Galea, chief data and analytics officer, WCG 
• Melissa Hutchens, vice president of research and benchmarking, WCG 

Join us for "Breaking Down Site Complexities and Start-Up Barriers in Clinical Trials" as we uncover the complexities of site management and the barriers to effective study start-ups. Discover the top issues impacting research sites and strategies to overcome them, including trial complexity, start-up hurdles, and long initiation timelines.  

Learn how effective communication, teamwork, and clear processes can drive success, and the importance of human connections and inclusivity in clinical research. Get practical advice for improving site readiness and trial efficiency from our expert guests.  

Don't miss this essential episode on navigating the evolving clinical trial landscape at sites. 

Guests:

Jessica Thurmond, program director, WCG 

Pat Harrington, senior vice president, Clinical Solutions & Strategic Partnering, WCG 

Brad Gruener, vice president, Site Services, WCG 

Join us for a compelling episode of WCG Talks Trials where we take a look into the rewarding world of clinical trials and clinical development. In this episode, George Cokenakes, director of clinical services, review solutions, WCG, speaks with Dr. James Januzzi, a renowned cardiologist at Massachusetts General Hospital, and chief scientific officer at Baim Institute for Clinical Research. Dr. Januzzi shares his inspiring journey, highlighting the significance of clinical trial participation and the diverse opportunities that can shape a medical career. 

Learn from Dr. Januzzi's extensive experience in clinical research, including his work on cardiac biomarkers, drug therapy development, and involvement in various therapeutic areas. Discover how career decisions and active engagement in clinical trials can open doors to numerous possibilities and significantly impact patient care. 

Tune in for this insightful conversation and gain valuable advice for budding clinicians and researchers. 

Speakers: 

George Cokenakes, PMP, director of clinical services, review solutions, WCG 

James Januzzi, MD, FACC, cardiologist, Massachusetts General Hospital and chief scientific officer, Baim Institute for Clinical Research 

In this episode of "WCG Talks Trials," host Geoffrey Schick, director of strategic site partnerships, WCG, is joined by fellow MAGI@home 2024 speakers Sandy Smith, Jess Thompson, and Wesley Warren. They share their unique perspectives and key takeaways from this year's virtual conference, including discussions on contract negotiations, the evolving role of advanced practice practitioners, and the collaborative panels featuring both site and sponsor/CRO insights. The episode also recaps the impactful session on the FDA's Diversity Action Plan and what it means for the future of clinical trials. Tune in to hear about the dynamic energy, valuable connections, and innovative challenges that make MAGI and MAGI@home standout events in clinical research. Don't miss out on the exciting plans for MAGI 2025 in Boston, where trends will continue to evolve and new opportunities will emerge. 

Guests: 

• Geoffrey Schick, MBA, CHRC, Director of Strategic Site Partnerships, WCG  
• Sandy Smith, RN, MSN, AOCN, Senior Vice President, Clinical Solutions & Strategic Partnerships, WCG 
• Jess Thompson, MS, MBA, PMP, Founder, ACRPM.org 
• Wesley Warren, J.D., Executive Director, Research Strategy & Partnerships, City of Hope 

In this episode of WCG Talks Trials, host Sandy Smith, senior vice president of clinical solutions and strategic partnering at WCG, dives into the highlights of the Florence Healthcare Research Revolution event. Sandy is joined by industry experts Andrea Bastek, vice president of innovation at Florence, and Lauren Sobocinski, senior vice president of strategic alliances at WCG, to discuss transformative insights from the event. Discover the latest trends shaping clinical research, including site engagement, protocol complexity, and effective sponsor-site relationships. Tune in for a compelling discussion on how collaborative efforts and innovative technologies are driving positive change in the clinical trial landscape. 

In this episode of WCG Talks Trials, host Kelly FitzGerald sits down with Dr. Currien MacDonald, Medical Chair Director at WCG, and Sara Reed, a participant in two psychedelic clinical trials, to explore the evolving landscape of psychedelics research. Dr. MacDonald shares his expertise on the growing acceptance of psychedelics in clinical settings, recent FDA updates, and the inner workings of ongoing trials. Later, Sara provides a firsthand account of her experiences as a trial participant, offering unique insights into how psychedelics are being tested as potential therapeutic options. Tune in to learn more about aligning clinical practice with patient experience in this emerging field.

In this episode of WCG Talks Trials, Geoff Schick, director of strategic site partnerships, joins our host Sandy Smith, senior vice president of clinical solutions and strategic partnering, to discuss the expansion of research site cancer portfolios.

Join Desiree Underwood-Williams, director of project management organization at WCG and guest Steve Smith, CEO of SteveSmithPlans LLC and facilitator of the WCG Patient Forum, as they recap the latest Patient Forum Focus Session on breakthrough science and community engagement. Discussion highlights include:

• The impact of medical diagnoses on families with Sickle cell disease and melanoma.
• New research in cell and gene therapy that’s directly impacting Sickle cell  disease and melanoma patients.
• New diversity laws shaping the future of drug development.
• Community engagement and how patients can get involved in their care.
• And more insights into the WCG Patient Forum, now in its fifth year.

Tune in to learn more about clinical research, community engagement, and the latest developments in patient care.

 In this episode of WCG Talks Trials, we are joined by host Joanne Thomas, clinical reviewer and patient advocate at WCG, along with our guest Currien MacDonald, medical chair director at WCG. This episode covers the roles of IRB in ethical clinical research, frequently asked questions, and a general overview of the IRB’s role in clinical trials.

This episode of WCG Talks Trials addresses site feasibility challenges impacting the clinical trials industry. Join Michelle Yu, associate director of clinical strategy at WCG, and our guest Trevor Cole, director of client delivery, site and strategic operations for WCG, as we discuss approaches to adopt innovative feasibility and site start-up solutions.

Here are links to documents referenced in this episode:


Recommendations to Streamline and Standardize Clinical Trial Site Feasibility Assessments: An ASCO Research Statement

• Main Article: https://ascopubs.org/doi/10.1200/OP.20.00821  
• PDF Data Supplement: https://society.asco.org/sites/new-www.asco.org/files/content-files/about-asco/documents/2020-ASCO-Site-Feasibility-Assessment-Statement-Data-Supplement-for-JCO-OP.pdf 

Join our Chief Analytics Officer Silvio Galea, along with Dr. Donna Snyder & Dr. Barbara Bierer to discuss opportunities on the ethical and regulatory challenges regarding artificial intelligence in clinical trials. The discussion is focused through the lens of the IRB review, and how a multi-stakeholder task force led by the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women's Hospital and WCG will address the growing need for guidance in this rapidly evolving area of research.

In this episode of WCG Talks Trials, we are joined by WCG clinical science experts as they discuss traditional measurement challenges for PTSD trials and how the use of an electronic CAPS-5 scale is improving administration and scoring errors. 

Tune in as we discuss the CAPS-5 scale, the opportunities and benefits of using an electronic version to help standardize scale administration and scoring across clinical research, and the promising results to date. 

In the most recent episode of WCG Talks Trials, we are joined by three industry experts, Amy Thue and Shelby Ward from WCG, and Russell Lampman from Merck to discuss the topic of optimizing vendor support, and ultimately the success, of clinical trials.

Listen in as we dive into feedback and perspectives from both the sponsor and vendor side of the table—for valuable take-aways and insights into how vendor support is best aligned across all stakeholders.

In Part 2 of this discussion, Currien MacDonald, MD, CIP Medical Chair Director for WCG's IRB, discusses new FDA regulations for waiver of consent with Kelly Fitzgerald, PhD, WCG's IRB Executive Chair and VP IBC Affairs. 

In Part 1 of this discussion, Currien MacDonald, MD, CIP Medical Chair Director for WCG's IRB, discusses a policy change that is going into effect for WCG IRB with Lindsay Abrahams, Regulatory Chair Director. 

Lindsay and Currien discuss the concise summary and its application to consent forms, especially for WCG.

In this episode of WCG Talks Trials, our expert panel discusses various ethical, safety, and logistical challenges in accelerating clinical trials for gene and cell therapies in oncology. The conversation explores the role of Institutional Review Boards (IRBs), Institutional Biosafety Committees (IBCs), Endpoint Adjudication Committees (EACs), and Data Monitoring Committees (DMCs) in overseeing these trials, addressing issues such as patient safety, complex trial designs, and emerging biosafety concerns. Our panelists emphasize the importance of transparent communication and collaboration between IRBs and IBCs, highlighting the need to balance the urgency of advancing research with ethical considerations. Additionally, the podcast explores unrealized ethical and safety issues, such as the pace of technological advancements and potential risks associated with gene editing. The speakers also touch upon future opportunities in oncology research, including precision medicine, artificial intelligence, wearable devices, and accelerated regulatory pathways.

In episode 10 of WCG Talks Trials, we are joined by Catherine Gregor, the Chief Clinical Trial Officer at Florence Healthcare, to discuss Florence’s recent Research Revolution event and the importance of site enablement in clinical research. Listen in as we recap Research Revolution, share insights on emerging clinical trial trends and innovations, and have a candid conversation about what stands in the way of successful site enablement in clinical research. 

In this episode of WCG Talks Trials, we are joined by Elizabeth Weeks-Rowe, CCRA, author of The CRA’s Guide to Monitoring Clinical Research, 6th Edition.

Led by WCG Director of Publications and Content, Leslie Ramsey, the discussion will delve into the ways the clinical trials industry has become more complex and technologically focused and the challenges clinical research associates (CRAs) face as monitors of clinical trials.

Host: Leslie Ramsey, Director of Publications and Content, WCG

 Participant: Elizabeth Weeks-Rowe, Independent Clinical Research Consultant

In this episode of WCG Talks Trials, we are joined by MAGI@home Steering Committee members, Jennifer Peterson, Director, Head of Clinical Quality at M3 Wake Research, and Geoffrey Schick, Director, Strategic Site Partnerships at WCG. 

Led by Carmin Gade, Chief Marketing Officer at WCG, the discussion will delve into the insights and value MAGI events provide that enable attendees to achieve success in their roles and professional development.

This episode of WCG Talks Trials, hosted by Kelly Fitzgerald, Executive IRB Chair and Vice President of IBC Affairs at WCG, dives into the topic of diversity and inclusion with technology in decentralized clinical trials (DCTs). The episode explores the transformative opportunities that DCTs present for addressing diversity gaps in clinical research. The discussion features a panel of experts, including Otis Johnson, former Chief Diversity, Inclusion, and Sustainability Officer at Clario; Archana Sah, a seasoned clinical development leader with a focus on oncology and healthcare technology; and Ken McCann, a physician with a background in pediatrics and a keen interest in social determinants of health. The panelists share insights on how DCTs can improve accessibility, overcome barriers, and enhance representation in clinical trials, emphasizing the potential for these trials to be a game-changer in making clinical research more equitable and inclusive. 

Guests:

• Archana Sah MS (Pharm.) PMP 
• Otis Johnson, PhD, MPA
• Ken McCann, MD 

Listen to the latest episode of WCG Talks Trials to hear from experts on the importance of patient advocacy in clinical research and key takeaways from WCG's 2023 Patient Forum. We'll summarize how the patient forum elevates the voices of those changing drug development for the better and recap breakthroughs and best practices shared during the most recent event.

Discover more about patient and researcher collaboration, expanding diversity, equity, and inclusion in trials, and the latest advocacy-driven technology, science, and policy breakthroughs leading to modernized clinical research.  

Guests:

• Desiree Underwood-Williams, PMP, CLSSBB, Director, Project Management Office, WCG
• Steve Smith, President, Patient Advocacy, WCG 

Listen to the latest episode of WCG Talks Trials to hear from experts on the importance of diversity, equity, and inclusion in clinical research and how intersectionality plays a role in promoting DE&I. We'll discuss why diversity is pivotal for comprehending the full spectrum of clinical care mechanisms and review effective DE&I strategies being deployed today. Discover how communities can be more actively engaged in clinical research and hear real-world examples of success stories in promoting diversity, equity, and inclusion within clinical research.

Moderator:

• Scott J. Hunter, PhD - Senior Scientific Expert, Neurodevelopmental and Rare Pediatric Diseases, WCG

Speakers:

• Sonya Dinizulu, PhD - Associate Professor of Psychiatry and Behavioral Neuroscience, University of Chicago 
• Desiree Underwood-Williams, PMP, CLSSBB – Director, Project Management Office, WCG 

Join WCG Talks Trials podcast host Kelly Fitzgerald, PhD, in a riveting dialogue with guest expert Currien MacDonald, MD, as they unravel the nuances of "Psychedelics in Research: Ethical and Medical Perspectives." 

Dr. MacDonald, with a solid foundation in family medicine and clinical trials administration, guides listeners through a grounded exploration of psychedelic substances. In this episode, they demystify the realm of psychedelics, encompassing both dissociative and classic varieties, such as LSD and MDMA. 

As the conversation delves into ongoing research, the potential applications of these compounds in treating mental health challenges like depression, anxiety, and post-traumatic stress disorder come to the fore. The dialogue doesn't shy away from probing the ethical dimensions surrounding psychedelic research, addressing concerns about study design, potential abuse, and the intricate balance between benefits and risks. This insightful podcast offers an engaging journey into the evolving field of psychedelic research, shedding light on its medical potential and the ethical considerations that guide its path.

In episode three of WCG Talks Trials, two WCG experts discuss key findings from the 2023 Avoca State of the Industry Report, which provides a 360-degree view on motivators and deterrents to clinical trial participation.

Listen in as we dive into feedback from perspectives across all clinical research stakeholders — sponsors, providers, sites, and patients — for valuable take-aways and insights into the trial experience.

Speakers:

Crissy MacDonald, PhD, Vice President, Client Delivery, WCG Avoca

Gina DiCindio, Associate Director, Industry and Client Research, WCG Avoca

In episode two of WCG Talks Trials, we are joined by two WCG experts to discuss overcoming common enrollment challenges and how DE&I, technology, and protocol design factor into enrollment success.

Listen in as we delve into the critical topic of common enrollment barriers in clinical trials, how to improve enrollment by focusing on DE&I efforts, the importance of site-centric and patient-centric technologies, and how thoughtful protocol design plays a significant role in enrollment success.

Speakers:

• Dawn Sauro, Chief Growth Officer, WCG
• Jamie Harper, MHA, CCRP - Vice President, Site Solutions & Engagement at WCG
• Tyler Bye - Director, Site Solutions & Product Strategy at WCG

In the first episode of our new podcast series, WCG Talks Trials, we are joined by three industry experts, Lisa Ballance from Virginia Commonwealth University, John Musser from Florida Cancer Specialists and Research Institute, and Dan Otap from Genentech, to discuss the topic of overcoming site challenges and addressing site burden.

Listen in as we discuss the results of WCG’s recently published 2023 Clinical Research Site Challenges Survey Report, gain insights from our guests on solutions their organizations have implemented to reduce site burden, and share perspectives on how sites, sponsors, and CROs can work to improve site and trial efficiency.

Speakers: 

• Sandy Smith, RN, MSN, AOCN 
  Senior Vice President, Clinical Solutions and Strategic Partnerships at WCG Clinical
• Lisa Richman Balance
  Associate Vice President for Research Strategy and Regulatory Affairs at Virginia Commonwealth University 
• John Musser
  Senior Director, Clinical Research Administration at Florida Cancer Specialists & Research Institute
• Dan Otap
  Principal, Alliance and Partnerships Lead at Genentech

Bernadette Siddiqi, associate director of research partnerships at The Michael J. Fox Foundation for Parkinson’s Research talks about how they give members of the public access to the Fox Trial Finder. This clinical trial search tool that allows anyone to search for Parkinson’s disease clinical trials. More than 300 are listed on the site.

It’s a bottleneck in clinical research. Patients are eager for a cure, but it can be difficult for them to connect to trials and for researchers to connect to volunteers.

Bernadette speaks of why it is critical to the foundation’s mission to provide an easy way to make this connection. Just as important, she says, is educating people about research. Fox Trial Finder provides both. Roughly 700 people visit the site each month.

The Michael J. Fox Foundation for Parkinson’s Research is dedicated to finding a cure for Parkinson’s disease through an aggressively funded research agenda.

Movement disorder trials have always been demanding. Now, sponsors face an additional challenge: How do you ensure data integrity in the era of remote clinical trials? In this podcast, Bob Dagher, MD, WCG MedAvante-ProPhase’s Chief Medical Officer, addresses this in conversation with Steve Smith, WCG President of Patient Advocacy. This is the fourth episode in our series, “Transforming CNS Trials During COVID-19—and Beyond.”

Sponsors planning to restart movement disorder programs need to be clear-eyed and realistic, Dagher counsels. “When it comes to remote assessments, we have to be vigilant and aware of what we can do and also about what we really cannot do.” Some assessments simply cannot be performed remotely. This means sponsors will need to figure out how to account for variability and missing data in their statistical plan before locking the database.

FDA guidance on the conduct of trials during COVID-19 helps provide a roadmap. For example, in the case of anticipated missing data the guidance clearly states to capture specific information in the case report form that explains the relationship to COVID-19.
But it also requires in-depth scientific and clinically-informed knowledge so that the quality of the data captured isn’t sacrificed as direct result. Accordingly, WCG has been working with clients to tailor remote assessments for sponsors’ trials, yielding assessments that are as close as possible to the in-person versions (minus those particular items that cannot be done remotely).

Dagher’s message? “Ensuring data integrity at every step of the process should be the primary guide for any decision-making process when deciding to restart your study.”

Prior to joining WCG MA-PP, Dr. Dagher, was the Chief Medical Officer of Cadent Therapeutics in Cambridge, Mass. Before that, he served in many leadership roles at small and large biopharmaceutical and clinical research organizations, including GlaxoSmithKline, Genzyme, Sanofi and Covance, among others. Dr. Dagher has fostered the development of multiple products in different indications and development platforms and advanced several small molecules and biologics across all stages of clinical development. His background includes therapeutic experience in psychiatry, neurology and rare diseases.

As a global strategist for Intel’s Health and Life Sciences Group, Bryce Olson had an up close view of innovation happening in the lab—especially in terms of genomic sequencing and gene therapy. As a man diagnosed with aggressive stage 4 prostate cancer at 44, he had as well an up close view of how that innovation was not being translated into the clinic. 

He was started on a one-size-fits-all standard of care. It didn’t work, and chemo made him ill. In this podcast episode, he talks about how he demanded—and received—DNA sequencing. That data led him to find the right trial and the right medicine for his type of prostate cancer.

He’s now a very vocal advocate of sequencing. Among other endeavors, he founded Sequence Me (www.sequenceme.org), a patient-driven movement to accelerate access and adoption of new genomic sequencing innovations for cancer.

In major depressive disorder, researchers have used remote assessments for decades. As a result, many of these studies have had an easier time adapting to the new clinical trial landscape. But that doesn’t mean they are pandemic-proof.

So what are the critical success factors for clinical depression programs—especially now? 

In his conversation with WCG President of Patient Advocacy Steve Smith, Mark Opler, PhD, MPH, Chief Research Officer at WCG MedAvante-ProPhase offers his insights on the future of clinical depression trials. This is the third episode in our podcast series, “Transforming CNS Trials During COVID-19—and Beyond.”

We’re headed in the right direction by enabling more patient-friendly evaluation, but – especially in light of the pandemic – we must continue to refine these systems and make sure that we have the input of patients, caregivers, and of course, investigators.

Among his recommendations: Ensure clinicians have the right depression-assessment tools and that they are using them correctly.

It’s also critical, he says, to have a solid remote assessment methodology in place. This means not only incorporating the right tools, but also establishing a way of continuously protecting data quality, such as WCG's Study Insight Analytics Platform.

Mark Opler, PhD, MPH, is Chief Research Officer at WCG MedAvante-ProPhase. Dr. Opler was the founder of ProPhase and served as its CEO and Chief Scientific Officer, among other roles. He serves as adjunct assistant professor of psychiatry at New York University and assistant professor of clinical neuroscience at Columbia University’s College of Physicians and Surgeons. He is also leading the development of the forthcoming edition of the PANSS Manual.

LaTasha Lee, PhD, MPH’s path to becoming a sickle cell disease (SCD) researcher and policy advocate began as a child. Because the SCD trait ran in her family, she became a patient advocate while still small. Today, she is Vice President, Social and Clinical Research & Development, at the National Minority Quality Forum. In this wide-ranging interview, she touches on an array of issues affecting the SCD community. Among them: adult patients who end up in the emergency room, the increased number of available therapeutics and the robust pipeline of SCD therapies.

Of particular concern is the challenge of accessing pain medication — both in the ER and in primary care practices. “Individuals with this disease often aren’t believed. They are considered drug seekers when they aren’t.”

She also makes a passionate call for increased minority participation in healthcare and in research to enhance equity and improve outcomes.

Dr. Lee is responsible for the oversight and implementation of research projects and programs focused on reducing patient risk and identifying optimal care to reduce health disparities and bring about health equity at the National Minority Quality Forum. Before that, she served as Senior Manager of Partnership Engagement of the Sickle Cell Disease Clinical Trials Network (SCD CTN) at the American Society of Hematology (ASH) Research Collaborative. She was responsible for establishing, implementing and maintaining effective partnerships with stakeholders including patients, academic medical centers, other clinical research sites, industry, and federal agencies regarding their interests in SCD CTN. As an experienced research manager at ASH she was tasked with the development of a patient engagement strategy and clinical trials network for SCD. While at ASH, Dr. Lee was also responsible for the day-to-day management and implementation of projects, programs and activities related to ASH’s Call to Action on Sickle Cell Disease.

At 51, Jeffrey Borghoff was diagnosed with Alzheimer’s disease. What would devastate many people turned Borghoff into an advocate. The former software architect and developer is now a national spokesperson for the Alzheimer's Association and board member of the Greater New Jersey chapter.

In this podcast, he talks about how the diagnosis forced him to reprioritize his life. “I've been pretty successful at that. I've been leading a very purposeful, engaging, joyful life.” With his care partner—his wife, Kimberly—he travels around the country making the case for research funding—and for clinical trial participation. 

That’s critical because important Alzheimer’s trials focus on younger-onset AD patients. Unfortunately, many people who are beginning to show signs at a very young age want to deny they have the disease. They won’t go into trials or even get a diagnosis. His messages to them: This disease does not define who you are, and research is important.

Remote assessments have become a necessity across CNS trials, but some areas are more complicated than others. Schizophrenia provides one such example; the risk of variability is high, and sponsors are concerned. In this podcast, Mark Opler, PhD, MPH, Chief Research Officer at WCG MedAvante-ProPhase, sits down with WCG President of Patient Advocacy Steve Smith to discuss the topic. This is the second episode in our podcast series, “Transforming CNS Trials During COVID-19—and Beyond.”

PANSS—the gold standard rating scale for schizophrenia primary outcomes—is based largely on face-to-face interviews; it wasn’t developed for remote assessments. Is it still usable? Yes, says Dr. Opler. “I’m pleased to report that the anecdotal experience, as well as available data, suggests assessments conducted with patients with schizophrenia via video can be done reliably and can be done in a way that produces valid data.”

It can be done—the tools exist. But it’s the way sponsors and CROs approach remote assessments that can make or break data integrity—and he delves into that topic in this podcast. In particular, he shares how sponsors and CROs can leverage remote assessments in their next clinical trial.

Mark Opler, PhD, MPH, is Chief Research Officer at WCG MedAvante-ProPhase. Dr. Opler was the founder of ProPhase and served as its CEO and Chief Scientific Officer, among other roles. He serves as adjunct assistant professor of psychiatry at New York University and assistant professor of clinical neuroscience at Columbia University’s College of Physicians and Surgeons. He is also leading the development of the forthcoming edition of the PANSS Manual.

Lisa Deck was a healthy 21-year old a week away from college graduation when her first stroke put her in the hospital. She barely made it to her graduation ceremony. She suffered two more strokes before she turned 25, and after that, a fourth stroke.

After serious misdiagnosis and incorrect treatments, she was finally diagnosed with Moyamoya disease, a rare condition without a cure, but it does have a surgical treatment.
 
In this podcast, she shares her diagnostic odyssey, her commitment to advocacy and the value of peer and family support. She also talks about the importance of staying positive and why patients must advocate for themselves.

How can CROs and sponsors detect potential problems and issues in clinical trial conduct and data quality? That’s one of the critical issues discussed in Steve Young’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Young, Chief Scientific Officer at CluePoint, discusses how risk-based quality management (RBQM) methodology, data analytics, and data surveillance are being utilized today to go beyond just ferreting out fraud.  Now, Young says, clinical trial stakeholders are deploying advanced statistical engines to detect quality and data breaches in investigational studies. According to Young, while there are still instances, to varying degrees, of major misconduct in clinical trials, CROs and sponsors are increasingly turning to online solutions to risk planning. It’s important, he adds, that when risks are discovered, the solutions are integrated into the workflow of clinical trials. In fact, Young asserts, one of the biggest challenges facing the industry today is to embrace change and accept the use of centralized monitoring data to aid in the discovery and resolution of risk.        

Interested in attending the MCC Clinical Trial Risk and Performance Management vSummit Sept. 8-10? Visit https://www.centerwatch.com/mcc-summit-2020.
If you subscribe to this podcast, you can use the code POD15 to receive 15% off your registration fee. 

For many of the same reasons underrepresented populations lack access to appropriate healthcare services, they are also left out of clinical trials. The problem is widely known, but solutions have been hard to come by. In this episode, Michael Poku, MD, MBA, biopharma medical director at Signify Health, explains why this is the case and then shares some approaches he and his colleagues have successfully used to remove the barriers to clinical trial participation.

An important aspect is understanding the larger picture—that inequality is due to in large measure to longstanding and systemic issues. He discusses how unmet social needs rarely occur in isolation. Addressing those needs together can lead to better representation in clinical trials. 

“Sponsors are incredibly excited about opportunities to make their trials more representative and to have underrepresented minorities participate,” he says.

In addition to his work at Signify Health, Dr. Poku is on clinical faculty at Methodist Dallas Medical Center and the University of Texas Southwestern Medical Center, where he cares for patients as an internist and teaches trainees and medical students. Prior to his role at Signify Health, Dr Poku was a consultant at McKinsey & Company.

Dana Deighton, an esophageal cancer survivor, shares her diagnostic odyssey of false starts and life-threatening detours.

Deighton had always been healthy—she didn’t smoke, didn’t drink and exercised every day. Then came a joint pain that wouldn’t go away, visits to numerous doctors, a series of misdiagnoses, invasive tests, and growing symptoms. The correct diagnosis of stage 4 esophageal cancer “was not the diagnosis anyone wants.” But she refused to accept physicians’ recommendations for palliative care as a solution.

She describes her persistent advocacy to convince doctors to consider her as an individual different from expectations and generalizations. She asked the hard questions and had the hard discussions, resulting in an outcome better than expected.

She recommends physicians and patients do the homework, energetically collaborate and consider the individual patient in the quest for a solution. “Don’t be a passive patient.”

Dana Deighton works for the online patient community provider Inspire.com that helps connect patients with others experiencing the same disease, for a wide variety of diseases and over 4 million members.  She also serves as an Executive Board Member of the Esophageal Cancer Action Network (ECAN), is a patient representative on the Locally Advanced Esophageal Cancer Guideline Panel for the American Society of Clinical Oncology (ASCO), a member of NCI Patient Advocate Steering Committee and NCI Esophago-Gastric Task Force and serves on the Esophageal and Stomach Cancer Project Patient Advisory Committee, a project led by the Broad Institute of MIT and Harvard. She lives outside of Alexandria with her husband and three teenagers.

Can patients be trained to report their symptoms more accurately? That’s one of the key topics discussed in Nat Katz’s and Art Morales’ interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Katz, the Chief Science Officer of WCG-Analgesic Solutions and Morales, Vice President, Technology Solutions at WCG, assert that, with proper design and implementation, you can structure clinical trials, such as pain management studies, so that patients learn how to better report their symptoms. With proper training, patients learn to accurately report their symptoms, resulting in more reliable data, according to Katz and Morales. During COVID-19, they add, sponsors have had the opportunity to examine ways to introduce new technologies, such as telehealth, to clinical trial operations and to use more science-based tools for evaluating the performance of clinical trials. COVID-19 also has accelerated the scientific evaluation of clinical sites by optimizing the analysis of patient data. The result: Clearer and more reliable data collected during the conduct of study — without unblinding the data. 

Interested in attending the MCC Clinical Trial Risk and Performance Management vSummit Sept. 8-10? Visit https://www.centerwatch.com/mcc-summit-2020. If you subscribe to this podcast, you can use the code POD15 to receive 15% off your registration fee. 

How are clinical trial companies pivoting to implement Risk-Based Quality Management programs during the pandemic? That’s one of the deep dives explored in Duncan Hall’s and Rachel Oakley’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Hall, founder and CEO of Triumph Research Intelligence (TRI) and Oakley, Vice President of RBQM Services at TRI, note that, when the COVID-19 pandemic first hit, CROs and sites performed risk assessments on their existing studies. Then those organizations took advantage of innovative technology that had a key tool for optimizing clinical trials — centralized monitoring. According to Hall and Oakley, that tool enables critical oversight and monitoring of investigational sites, even when in-person visits are not feasible. They point out that regulatory agencies are issuing new guidance during the pandemic, and that sponsors, CROs, and sites need to figure out how to comply with both those new mandates as well as existing rules. According to Hall and Oakley, there has been a renewed sense of community in the industry in dealing with the pandemic as stakeholders try to stay current through a variety of trusted sources, including MCC’s weekly COVID calls. Finally, they note, one component for optimizing clinical trials is taking center stage — training, especially in the area of RBQM.

Interested in attending the MCC Clinical Trial Risk and Performance Management vSummit Sept. 8-10? Visit https://www.centerwatch.com/mcc-summit-2020. 

If you subscribe to this podcast, you can use the code POD15 to receive 15% off your registration fee.

What’s the secret to success for implementing a world-class holistic approach to a Risk-Based Quality Management (RBQM) system? That’s one of the key topics from Artem Andrianov‘s and Johanna Proeve’s interview with Executive Director of WCG’s Metric Champion Consortium (MCC), Linda Sullivan, MBA. Andrianov, CEO, and Proeve, Chief Science Officer at Cyntegrity emphasize the importance of developing a clinical trial platform that enables your organization to manage the entire quality management cycle rather than continuing with traditional silo-based approaches. This comprehensive approach, they explain, enables pharmaceutical companies to become more efficient in reducing risk, which is especially important during the current pandemic. In addition, they note, in the COVID-19 era, more organizations have had to turn to holistic risk-based quality management systems because, for example, Excel doesn’t always work for managing RBQM, especially in larger clinical trials. Today, both CROs and sponsors are implementing innovative RBQM technology and asking for additional training to deal with data quality deterioration and other issues brought about by the onslaught of the pandemic, according to Andrianov and Proeve. Listen to this episode to find out how COVID-19 has magnified festering clinical trial shortcomings and why it’s essential that pharmaceutical company leaders become “data scientists.”

Interested in attending the MCC Clinical Trial Risk and Performance Management vSummit Sept. 8-10? Visit https://www.centerwatch.com/mcc-summit-2020. 

Ever since elementary school, Gregory L. Hall, MD, knew he would be a doctor. In this interview, he shares that journey and how he came to write the book—literally—on health disparities for African Americans.

His focus on disparities began more than 30 years ago with his appointment to the Ohio Commission on Minority Health—the first such commission in the country. Eventually, when he became the chairman, he had to give quarterly reports. The research he conducted on disparities for those reports opened his eyes, he says.

“I naively believed that providers and physicians didn’t contribute to health disparities. I thought it was just poverty and a lack of insurance. I didn’t know that, actually, providers contribute to it, health systems contribute to it.” He was shocked, and what he learned led to him write his book, Patient-Centered Clinical Care for African Americans: A Concise, Evidence-Based Guide to Important Differences and Better Outcomes. It is for physicians and clinicians and is a guide outlining specific differences in communication, clinical therapies, medications, protocols and other critical approaches to the care of African Americans.

The book discusses a wide range of disorders that affect African Americans It includes clinical pearls, but it also provides the background clinicians need to understand just what drives disparities.

Providers don’t want to exacerbate disparities, but they are often unaware. If you don’t know what you’re doing wrong, you can’t fix it, he says. He is helping with both. 

Even when providers do a better job addressing the specific needs of African-American patients, hurdles remain, he says. For example, lack of trust remains a huge issue among African-American patients; the shadow of historic discrimination in medical settings looms large. Almost half of African Americans report low trust of healthcare providers—and what’s interesting, he notes, is that this distrust extends to providers of all races. As a result, African Americans often don’t seek out the care they need, and they are wary of clinical trials.

In addition to being a practicing primary care physician in Cleveland, Dr. Hall has a dual appointment on the teaching faculty at Northeast Ohio Medical University College of Medicine as associate professor of both internal medicine and integrative medical sciences. He also has an assistant clinical professor appointment at the Case Western Reserve University School of Medicine.