WCG Talks Trials

Latest Episodes:

The Importance of Diversity, Equity, Inclusion, and Intersectionality in Clinical Research Oct 27, 2023

Show notes

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

Delve into the World of Psychedelic Research and Ethical Inquiry Sep 26, 2023

Show notes

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.

A 360-degree View on Motivators and Deterrents to Clinical Trial Participation Sep 11, 2023

Show notes

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

Breaking Down Enrollment Barriers: How DE&I, Technology, and Protocol Design Impact Enrollment Success Aug 16, 2023

Show notes

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

Unlocking Site Potential: Reducing Site Burden and Enhancing Clinical Trial Efficiency Jul 16, 2023

Show notes

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

Connecting Patients to Trials: Bernadette Siddiqi of The Michael J. Fox Foundation for Parkinson’s Research Dec 16, 2020

Show notes

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.

On the Future of Movement Disorder Trials: Part 4 of WCG’s Transforming CNS Trials Series Oct 21, 2020

Show notes

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.

Prostate Cancer Survivor Bryce Olson’s Message: “Sequence Me!” Oct 08, 2020

Show notes

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.

On the Future of Depression Trials: Part 3 of WCG’s Transforming CNS Trials Series Sep 30, 2020

Show notes

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 H. Lee, PhD, MPH: Advocating for Health Equity, Advancing Sickle Cell Disease Research Sep 29, 2020

Show notes

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.

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