Addressing Challenges in Site Feasibility

WCG Talks Trials

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circa un anno fa 20:14

81 episodi

#Business #Clinical Trials #Pharmaceutical #Drug Development #Science #Fitness #Biology #Medicine #WCG

Addressing Challenges in Site Feasibility

WCG Talks Trials

published circa un anno fa

MP3•Pagina principale dell'episodio

81 episodi

#Business #Clinical Trials #Pharmaceutical #Drug Development #Science #Fitness #Biology #Medicine #WCG

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WCG Talks Trials

1
AI in Clinical Trials: Unlocking the Potential 27:54

6 weeks fa27:54

27:54

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…

WCG Talks Trials

1
Breaking Down Site Complexities and Start-Up Barriers in Clinical Trials 25:44

9 weeks fa25:44

25:44

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…

WCG Talks Trials

1
From Patient Care to Discovery: A Clinician's Journey into Research 19:45

20 weeks fa19:45

19:45

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…

WCG Talks Trials

1
Inside MAGI: Innovation, Education, and Industry Trends 29:19

22 weeks fa29:19

29:19

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…

WCG Talks Trials

1
Revolutionizing Clinical Research Through Collaboration and Innovation 28:54

25 weeks fa28:54

28:54

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.…

WCG Talks Trials

1
Have a Safe Trip: Clinical and Patient Alignment in Research with Psychedelics 23:27

29 weeks fa23:27

23:27

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.…

WCG Talks Trials

1
Breaking Barriers: Reasons to Expand Site Cancer Trial Portfolios 28:53

32 weeks fa28:53

28:53

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.

WCG Talks Trials

1
Patient Advocacy Advancing Breakthrough Science and Community Engagement 28:54

32 weeks fa28:54

28:54

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.…

WCG Talks Trials

1
Guarding Research Integrity: The IRB's Essential Role 27:27

33 weeks fa27:27

27:27

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.…

WCG Talks Trials

1
Addressing Challenges in Site Feasibility 20:14

35 weeks fa20:14

20:14

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…

WCG Talks Trials

1
Ethical Review and AI in Clinical Trials 39:43

44 weeks fa39:43

39:43

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.…

WCG Talks Trials

1
Addressing Measurement Challenges for PTSD Trials with Technology 21:40

46 weeks fa21:40

21:40

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.…

WCG Talks Trials

1
What Is E-Consent? Interview with Erin Brower 9:35

1 year fa9:35

9:35

WCG Talks Trials

1
Creating Partnerships: Aligning Vendor Support for Success in Clinical Research 20:56

1 year fa20:56

20:56

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.…

WCG Talks Trials

1
WCG's IRB Policy Change: Harmonizing Consent (Part 2) 8:06

1 year fa8:06

8:06

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.

WCG Talks Trials

1
WCG's IRB Policy Change: Harmonizing Consent (Part 1) 6:06

1 year fa6:06

6:06

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.…

WCG Talks Trials

1
The Ethical and Safety Considerations of Accelerating Oncology Trials 43:16

1 year fa43:16

43:16

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.…

WCG Talks Trials

1
Embarking on a Research Revolution – A Conversation with Florence Healthcare 30:37

1 year fa30:37

30:37

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.…

WCG Talks Trials

1
The CRA’s Evolving Role in a Postpandemic Industry 36:47

1 year fa36:47

36:47

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…

WCG Talks Trials

1
MAGI@home: Practical Intelligence, Real-life Examples, Actionable Information 29:26

1 year fa29:26

29:26

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.…

WCG Talks Trials

1
Diversity & Inclusion with Technology in Decentralized Trials 1:05:05

1 year fa1:05:05

1:05:05

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…

WCG Talks Trials

1
Amplifying Patient Voices to Advance Clinical Research: The Importance of Patient Advocacy 29:38

1 year fa29:38

29:38

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…

WCG Talks Trials

1
The Importance of Diversity, Equity, Inclusion, and Intersectionality in Clinical Research 36:48

2 years fa36:48

36:48

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…

WCG Talks Trials

1
Delve into the World of Psychedelic Research and Ethical Inquiry 25:48

2 years fa25:48

25:48

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.…

WCG Talks Trials

1
A 360-degree View on Motivators and Deterrents to Clinical Trial Participation 30:32

2 years fa30:32

30:32

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…

WCG Talks Trials

1
Breaking Down Enrollment Barriers: How DE&I, Technology, and Protocol Design Impact Enrollment Success 18:28

2 years fa18:28

18:28

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…

WCG Talks Trials

1
Unlocking Site Potential: Reducing Site Burden and Enhancing Clinical Trial Efficiency 35:53

2 years fa35:53

35:53

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…

WCG Talks Trials

1
Connecting Patients to Trials: Bernadette Siddiqi of The Michael J. Fox Foundation for Parkinson’s Research 12:27

4 years fa12:27

12:27

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.…

WCG Talks Trials

1
On the Future of Movement Disorder Trials: Part 4 of WCG’s Transforming CNS Trials Series 9:34

5 years fa9:34

9:34

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.…

WCG Talks Trials

1
Prostate Cancer Survivor Bryce Olson’s Message: “Sequence Me!” 24:26

5 years fa24:26