Insights from leaders in clinical research and trial optimization, hosted by the WCG Clinical.
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Mindset Movement”: Empowering conversations exploring the transformative power of mindset in personal growth and achievement. Thank you for listening, and a warm welcome to all first-time listeners joining our journey of growth and discovery.
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Addressing Challenges in Site Feasibility
20:14
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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 sol…
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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 Clinica…
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Addressing Measurement Challenges for PTSD Trials with Technology
21:40
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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 h…
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What Is E-Consent? Interview with Erin Brower
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By WCG
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Creating Partnerships: Aligning Vendor Support for Success in Clinical Research
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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…
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WCG's IRB Policy Change: Harmonizing Consent (Part 2)
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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.By WCG
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WCG's IRB Policy Change: Harmonizing Consent (Part 1)
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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.…
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The Ethical and Safety Considerations of Accelerating Oncology Trials
43:16
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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 …
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Embarking on a Research Revolution – A Conversation with Florence Healthcare
30:37
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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,…
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The CRA’s Evolving Role in a Postpandemic Industry
36:47
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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 cha…
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MAGI@home: Practical Intelligence, Real-life Examples, Actionable Information
29:26
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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 event…
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Diversity & Inclusion with Technology in Decentralized Trials
1:05:05
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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 researc…
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Amplifying Patient Voices to Advance Clinical Research: The Importance of Patient Advocacy
29:38
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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 mos…
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The Importance of Diversity, Equity, Inclusion, and Intersectionality in Clinical Research
36:48
36:48
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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 d…
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Delve into the World of Psychedelic Research and Ethical Inquiry
25:48
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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 explo…
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A 360-degree View on Motivators and Deterrents to Clinical Trial Participation
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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 p…
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Breaking Down Enrollment Barriers: How DE&I, Technology, and Protocol Design Impact Enrollment Success
18:28
18:28
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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, t…
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Unlocking Site Potential: Reducing Site Burden and Enhancing Clinical Trial Efficiency
35:53
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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 w…
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Connecting Patients to Trials: Bernadette Siddiqi of The Michael J. Fox Foundation for Parkinson’s Research
12:27
12:27
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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 b…
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On the Future of Movement Disorder Trials: Part 4 of WCG’s Transforming CNS Trials Series
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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 fourt…
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Prostate Cancer Survivor Bryce Olson’s Message: “Sequence Me!”
24:26
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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 …
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On the Future of Depression Trials: Part 3 of WCG’s Transforming CNS Trials Series
10:51
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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…
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LaTasha H. Lee, PhD, MPH: Advocating for Health Equity, Advancing Sickle Cell Disease Research
26:35
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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 intervi…
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Jeffrey Borghoff: Finding Joy and Purpose after an Early-Onset Alzheimer’s Diagnosis
27:22
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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…
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On the Future of Schizophrenia Trials: Part 2 of WCG’s Transforming CNS Trials Series
10:37
10:37
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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…
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Lisa Deck: Young Stroke Survivor Transforms Life-Altering Challenge into Purpose-Driven Advocacy for Others
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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 diseas…
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The Case for Centralized Monitoring: Optimizing Data Quality and Risk Management with Linda Sullivan and Steve Young
36:14
36:14
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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 manag…
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Michael Poku, MD, MBA: Improving Minority Representation in Clinical Trials
21:19
21:19
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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…
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Dana Deighton: Esophageal Cancer Patient and Persistent Activist For Her Own Survival
24:52
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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. T…
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Striving for Reliability: Optimizing Patient Report Data through World-Class Design Management with Linda Sullivan, Nat Katz, and Art Morales
38:58
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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,…
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The Upside of Centralized Monitoring During a Pandemic: Linda Sullivan, Duncan Hall, and Rachel Oakley on Optimizing Clinical Trials through Innovative RBQM Technology
41:55
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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) a…
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Get Rid of Those Silos: Linda Sullivan, Artem Andrianov, and Johann Proeve on How To Optimize Clinical Trials through RBQM
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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 a…
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Gregory L. Hall, MD: Writing the Book on Health Disparities in African Americans
22:29
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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 commissio…
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Turning Insights Into Action: Linda Sullivan and Ken Getz on How Metrics and Benchmarking Provide a Path To Optimizing Clinical Trials
34:38
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"What impact does a remote clinical team operating model have on clinical trial performance?" That’s one of the hot topics from Ken Getz’s interview with Executive Director of WCG’s Metric Champion Consortium (MCC), Linda Sullivan, MBA. He describes several projects that the Tufts Center for the Study of Drug Development (Tufts CSDD) is currently w…
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Lisa Carlton, PhD: Fighting Rare Diseases as a Mother, Patient Advocate and Regulatory Affairs Professional
22:13
22:13
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Lisa Carlton, PhD, understands rare childhood diseases both professionally and personally. She was already a scientist specializing in rare diseases when her daughter was diagnosed with one: tuberous sclerosis. As VP of Global Regulatory Affairs for a biotech drug developer she is involved in development of treatments for other rare diseases too. T…
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Peter A. DiBiaso, MHA: Taking on the Ironman, Mount Kilimanjaro and Parkinson’s disease: a clinical trials patient recruitment expert speaks about his own life as a patient
19:06
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Pharmaceutical executive Peter A. DiBiaso, MHA, a triathlete who has successfully completed the grueling Ironman, learned at age 49 he had early-onset Parkinson’s disease. He shares his experiences—and triumphs—in this episode. What started as a small tremor in his right hand and a stiffness in his right ankle ended up changing his life. It was a b…
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Now Is the Time: Making Your Clinical Trial More Resilient
32:13
32:13
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In this episode, host Linda Sullivan, MBA, Executive Director of WCG's Metric Champion Consortium (MCC) chats with Laurie Halloran, founder of the Halloran Consulting Group, about how she developed an on-demand drug development team that can fill in gaps in the clinical trial process for life science companies, whether these involve regulatory stra…
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Hong Liu, PhD, Making Chicago a Healthier City for Asian Americans
27:35
27:35
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To fully engage Chicago’s medically underserved Chinese and other Asian communities and to help them address their own health issues, Dr. Hong Liu’s Midwest Asian Health Association reaches out in Mandarin, Cantonese and other languages—and does so in culturally appropriate ways. The result is better access to healthcare for many low-income, often …
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Roslyn Daniels, Black Health Matters Founder and President, on Health Disparities and Exciting Communities About Health
20:49
20:49
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In this episode, Roslyn Daniels, the founder and president of Black Health Matters, talks about how her organization educates and motivates African-American communities about taking care of one’s own health. Seeing her own grandparents die too soon and recognizing that, in many communities, people are forced to choose between rent and healthcare, s…
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Dorelia Rivera: Health Disparities, a Career in Advocacy, and Saving Her Daughter’s Life
24:21
24:21
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Our guest this episode, patient advocate Dorelia Rivera, improves access to healthcare services and clinical trials for the underrepresented, including her own Hispanic community. Her advocacy ranges from community volunteer work, to jobs for a state health and human services department, a payor, and a rare disease drug company. She advocates on Ca…
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Christopher Gantz, Building Trust and minority enrollment in clinical trials at Thomas Jefferson Hospital in Philadelphia
21:58
21:58
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“Our research population should match our community population.” That’s one of the takeaways from Christopher Gantz’s interview with WCG President of Patient Advocacy Steve Smith. He describes several programs that help connect researchers with minority communities to increase engagement and access enrollment in clinical trials. Gantz is senior dir…
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Communicating the Value of Clinical Trials to Underserved Minority Communities
21:39
21:39
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In this episode, we learn about CISCRP’s AWARE for All campaign, which builds awareness of, creates access to and encourages participation in clinical trials. Ellyn Getz, Associate Director of Development and Community Engagement at CISCRP, The Center for Information and Study on Clinical Research Participation, discusses AWARE for All. CISCRP's fl…
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People, Process and Technology: The Right Combination for Successful Expert Committees
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44:43
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Independent expert committees provide essential validation of clinical data. Without their insights, sponsors risk missed signals, conflicts of interest and costly delays. But establishing a successful expert committee can be tricky. It requires the right combination of people, process and technology. In this three-part podcast, Lakshmi Sundar, hea…
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Bringing Clinical Trials Closer to Home: Smaller, Local Sites Build Trust & Provide Access to Local Communities
17:56
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In this episode, Dolly Niles, executive director of QUEST Research Institute, talks about the role of small research sites and the value of community outreach. QUEST, a multi-specialty independent research site in metro Detroit, has conducted more than 350 phase 1-4 trials since it was established in 1996. Niles talks about the role of agile smalle…
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Raise Your Voices: Social Network Provides Safe Place for Patients to Share Stories and Influence Research
15:45
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In this episode, Brian Loew, founder and CEO of online patient portal Inspire, talks about the value to patients and caregivers of providing a safe and trustworthy online social network--a “peaceable kingdom,” as he calls it. Millions of patients representing 3,500 diseases--including many rare ones --come to Inspire.com for online community discus…
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Here I talk about the 5am club book & why I joined the 5am club & how you can too!
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Brian Loew, The INSPIRE social network platform provides a safe place for patients to meet, learn, and influence research
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In this episode, Brian Loew, founder and CEO of online patient portal Inspire, talks about the value to patients and caregivers of providing a safe and trustworthy online social network: a “peaceable kingdom,” as he calls it. Millions of patients representing 3,500 diseases—including many rare ones—come to Inspire.com for online community discussio…
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Frank Sasinowski, MS, MPH, JD Hymen Phelps & McNamara: Rare Disease Regulatory Transformation: 1983 AIDS Crisis to Present
37:08
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Drug policy has transformed to bring transformative improvement to the way rare diseases are developed resulting in more FDA approved treatments. This transformation came about because of collaboration across stakeholders: patient advocates, the FDA, Congress, drug developers, researchers, and legal specialists. Profound change came in the mid 1980…
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Thomas Farrington: Cancer Survivor’s Prostate Health Network gets African American Communities Talking About Prostate Cancer
21:55
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In this podcast, Thomas Farrington, founder of the Prostate Health Network, speaks with WCG President of Patient Advocacy Steve Smith. Mr. Farrington discusses his experience with the healthcare system, coupled with his own research on prostate cancer, which led him to become a vocal advocate for prostate cancer patients and survivors. His advocacy…
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We Should Not Be Surprised: COVID-19 Disparities Lay Bare What’s Been There All Along
22:06
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In this episode, former Assistant FDA Commissioner Jonca Bull, MD, discusses racial disparities in healthcare, how COVID-19 has made them impossible to ignore, and how this highlights the need for diversity in clinical trials. Low-income minority communities are being hit disproportionately hard by COVID-19. Dr. Bull isn’t surprised: The current cr…
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