Revolutionizing Patient Recruitment in Clinical Trials: Unlocking Access and Accelerating Drug Development with Jill Pellegrino

Transformation in Trials

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הוסף לפני one שנה

תוכן מסופק על ידי Sam Parnell & Ivanna Rosendal, Sam Parnell, and Ivanna Rosendal. כל תוכן הפודקאסטים כולל פרקים, גרפיקה ותיאורי פודקאסטים מועלים ומסופקים ישירות על ידי Sam Parnell & Ivanna Rosendal, Sam Parnell, and Ivanna Rosendal או שותף פלטפורמת הפודקאסט שלהם. אם אתה מאמין שמישהו משתמש ביצירה שלך המוגנת בזכויות יוצרים ללא רשותך, אתה יכול לעקוב אחר התהליך המתואר כאן https://he.player.fm/legal.

Exile

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Episode 10: From Refugee to Radical 44:09

לפני 2 years44:09

הפעל מאוחר יותר

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לייק

אהבתי

44:09

When a young Eva Kollisch arrives as a refugee in New York in 1940, she finds a community among socialists who share her values and idealism. She soon discovers ‘the cause’ isn’t as idyllic as it seems. Little does she know this is the beginning of a lifelong commitment to activism and her determination to create radical change in ways that include belonging, love and one's full self. In addition to Eva Kollisch’s memoirs Girl in Movement (2000) and The Ground Under My Feet (2014), LBI’s collections include an oral history interview with Eva conducted in 2014 and the papers of Eva’s mother, poet Margarete Kolllisch, which document Eva’s childhood experience on the Kindertransport. Learn more at www.lbi.org/kollisch . Exile is a production of the Leo Baeck Institute , New York | Berlin and Antica Productions . It’s narrated by Mandy Patinkin. Executive Producers include Katrina Onstad, Stuart Coxe, and Bernie Blum. Senior Producer is Debbie Pacheco. Associate Producers are Hailey Choi and Emily Morantz. Research and translation by Isabella Kempf. Sound design and audio mix by Philip Wilson, with help from Cameron McIver. Theme music by Oliver Wickham. Voice acting by Natalia Bushnik. Special thanks to the Kollisch family for the use of Eva’s two memoirs, “Girl in Movement” and “The Ground Under My Feet”, the Sophia Smith Collection at Smith College and their “Voices of Feminism Oral History Project”, and Soundtrack New York.…

לפני שנה 29:08

MP3•בית הפרקים

Send us a text

This episode reveals alarming statistics about patient access to clinical trials, highlighting that only 3% of patients currently have access to participate. Our guest, Jill Pellegrino, CEO of Auto Recruitment, shares innovative strategies to engage the other 90% of the patient population and discusses the importance of digital advertising, pre-screening, and patient support in the recruitment process.
• Discussion on the low percentage of patient access to clinical trials
• Barriers for physicians and research sites in patient enrollment
• Strategies to engage patients through digital advertising
• Importance of pre-screening for trial eligibility
• The role of EMR technology in improving recruitment
• Ensuring patient engagement post-initial interest
• Feedback and response from clinical trial sites
• Future plans for wider patient access to clinical trials
• Emphasis on patient-centric approaches in clinical research
This week, if you have any questions about Auto Recruitment or want to connect with Jill, visit https://www.autorecruitment.com.

________
Reach out to Ivanna Rosendal
Join the conversation on our LinkedIn page

פרקים

1. Revolutionizing Patient Recruitment in Clinical Trials: Unlocking Access and Accelerating Drug Development with Jill Pellegrino (00:00:00)

2. Patient Recruitment in Clinical Trials (00:00:18)

3. Patient Engagement in Clinical Trials (00:08:49)

4. Enhancing Clinical Trials Through Patient Recruitment (00:11:42)

5. Revolutionizing Clinical Trial Patient Recruitment (00:23:06)

72 פרקים

#Science #Fitness #Biology #Entrepreneur #Business #Medicine #Sam Parnell & Ivanna Rosendal #Ivanna Rosendal #Sam Parnell

Revolutionizing Patient Recruitment in Clinical Trials: Unlocking Access and Accelerating Drug Development with Jill Pellegrino

Transformation in Trials

published לפני שנה

שתפו

MP3•בית הפרקים

Send us a text

________
Reach out to Ivanna Rosendal
Join the conversation on our LinkedIn page

פרקים

1. Revolutionizing Patient Recruitment in Clinical Trials: Unlocking Access and Accelerating Drug Development with Jill Pellegrino (00:00:00)

2. Patient Recruitment in Clinical Trials (00:00:18)

3. Patient Engagement in Clinical Trials (00:08:49)

4. Enhancing Clinical Trials Through Patient Recruitment (00:11:42)

5. Revolutionizing Clinical Trial Patient Recruitment (00:23:06)

72 פרקים

#Science #Fitness #Biology #Entrepreneur #Business #Medicine #Sam Parnell & Ivanna Rosendal #Ivanna Rosendal #Sam Parnell

כל הפרקים

1
Championing Diversity to Transform Clinical Research with Shelli Pavone 32:07

לפני 3 ימים32:07

32:07

Send us a text Join us for a conversation with guest Shelli Pavone, co-founder of Inlightened, to uncover the untapped potential of diversity in clinical trials. Discover how historical mistrust, structural barriers, and exclusion criteria continue to hinder diverse patient recruitment. Shelli sheds light on the transformative impact inclusive trials have on scientific integrity, safety, and the generalizability of results. By embracing diversity, not only do we align with regulatory expectations, but we also pave the way for innovation and trust in our healthcare systems. This episode promises to expand your understanding of why diversity in trial participation is a scientific necessity rather than just a moral obligation. Explore the importance of diversifying clinical trial staff to boost trial success and enrollment rates. Shelli discusses breaking the mold of traditional investigator homogeneity by incorporating minority physicians, which fosters trust and enhances trial outcomes. Her insights into the creation of Inlightened reveal a passion for revolutionizing access to healthcare expertise, championing diverse voices, and pushing for equitable innovation. Uncover how Enlightened endeavors to challenge the constraints of conventional investment patterns and encourages the industry to embrace ideas that promise greater societal benefits. This episode covers: • Exploration of historical mistrust in clinical trials • Challenges faced in diversifying patient recruitment • Benefits of having diverse voices in clinical research • The FDA's evolving stance on diversity in clinical trials • The role of diverse investigators in influencing patient enrolment • Strategies to reduce barriers and increase participation • Shelli's journey and passion for healthcare innovation • The overarching need for change in the clinical trial landscape Shelli Pavone: https://www.linkedin.com/in/shelli-pavone-a729b2/ Inlightened: https://getinlightened.com/ ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

1
Revolutionizing Neurological Care: Andreas Forsland and Gregg Johns on Assistive Technology and Brain-Computer Interfaces 56:23

לפני 16 ימים56:23

56:23

Send us a text In this episode we dive into Brain-Computer Interface (BCI) technology, where the brain's faint signals are harnessed to create life-changing applications. Andreas Forsland and Greg Johns emphasize the importance of community-driven innovation, guided by the Brainiac Council—a unique assembly of patients, caregivers, and experts. This collaborative approach ensures that the solutions developed address real-world challenges, improving communication and independence for those with severe impairments. The discussion also highlights a groundbreaking clinical trial with the University of Waterloo, showcasing how AI-enhanced devices can reduce social isolation and enhance quality of life. We also cover: • Importance of user feedback in product design • Communication technology for ALS, Parkinson's, and more • The regulatory challenges of medical device development • Integrating AI to improve user experience and interaction • Future vision for accessible health technology • Ethical considerations surrounding brain-computer interfaces Guests: Andreas Forsland: https://www.linkedin.com/in/andreasforsland/ Gregg Johns: https://www.linkedin.com/in/gregg-johns-product-leader/ ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

1
Revolutionizing Patient Recruitment in Clinical Trials: Unlocking Access and Accelerating Drug Development with Jill Pellegrino 29:08

לפני 5 weeks29:08

29:08

Send us a text This episode reveals alarming statistics about patient access to clinical trials, highlighting that only 3% of patients currently have access to participate. Our guest, Jill Pellegrino, CEO of Auto Recruitment, shares innovative strategies to engage the other 90% of the patient population and discusses the importance of digital advertising, pre-screening, and patient support in the recruitment process. • Discussion on the low percentage of patient access to clinical trials • Barriers for physicians and research sites in patient enrollment • Strategies to engage patients through digital advertising • Importance of pre-screening for trial eligibility • The role of EMR technology in improving recruitment • Ensuring patient engagement post-initial interest • Feedback and response from clinical trial sites • Future plans for wider patient access to clinical trials • Emphasis on patient-centric approaches in clinical research This week, if you have any questions about Auto Recruitment or want to connect with Jill, visit https://www.autorecruitment.com. ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

1
Navigating the Shift: From SAS to R in Clinical Trials with Sunil Gupta 34:59

לפני 14 weeks34:59

34:59

Send us a text Why has SAS been the cornerstone of clinical trials for decades, and what is causing the shift to R now? Join us on "Transformation in Trials" as we explore this pivotal transition with Sunil Gupta, a seasoned programmer who has navigated both worlds. Sunil elaborates on SAS's long-standing dominance due to its robust programming capabilities and ease of use for FDA reviewers. However, the landscape is changing as R garners attention for its graphical prowess and collaborative potential. The conversation highlights the growing trend of new graduates versed in R and Python, which alleviates the shortage of SAS programmers and signifies a modernization wave in clinical trials, ultimately aiming to accelerate drug development. Our discussion takes a deep dive into the collaborative spirit driving this transition, particularly through initiatives like Pharmaverse. This specialized extension of Tidyverse is designed to optimize clinical data workflows within the pharmaceutical industry. Sunil shares insights into how clinical programming is evolving, focusing on standardized data models and the unification of CDISC standards. The conversation underscores the importance of collaboration and resource sharing, allowing organizations to tackle complex challenges efficiently and improve patient outcomes while adapting to R's open-source environment and its growing acceptance in pharmaceutical submissions. Transitioning from SAS to R is not just about adopting a new tool; it's about mastering new skills and embracing change. Sunil discusses the challenges he faced when learning R, from understanding its functional approach to navigating intricate syntax. He offers personal anecdotes that reflect his journey and the broader industry shift, emphasizing the importance of validation processes and resource optimization. As we conclude this episode, we express gratitude for the platform to discuss these transformative changes and invite listeners to engage with us on future topics, continuing to share success stories that inspire more organizations to embrace the power of R. ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

1
Enhancing Vendor Oversight and Communication Strategies in Clinical Trials with Jessica Cordes 47:18

לפני 15 weeks47:18

47:18

Send us a text Prepare to transform your understanding of vendor oversight in clinical trials as we welcome Jessica Cordes, a senior consultant and trainer at the Clinical Excellence Consultancy. Jessica brings her wealth of experience to highlight the intricate responsibilities that sponsors must navigate when outsourcing tasks. Our conversation promises to equip you with insights on maintaining control, mitigating risks, and leveraging technology like AI and machine learning to future-proof your oversight strategies. Metrics are more than numbers—they're a lifeline in managing vendor relationships. Learn how robust oversight can impact patient safety and compliance metrics. We’ll explore the necessity of tailoring KPIs to specific risks and the importance of a risk-based approach that starts from vendor selection and continues through ongoing management. Jessica’s emphasis on creating a standard operating procedure framework will guide you in ensuring consistency and accountability in sponsor-vendor interactions. Effective communication is the cornerstone of successful clinical trials. Through personal anecdotes and practical advice, we tackle the challenges of unit-based contracts and introduce milestone-based contracts for enhanced efficiency. From vendor selection to team building, Jessica shares her consultancy insights tailored for small and mid-sized biotech and pharma companies. We also consider the upcoming ICH E6 R3 guidance, emphasizing fit-for-purpose procedures in quality management systems, all while advocating for improved collaboration among stakeholders to enhance patient-centricity and accelerate drug development. ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

1
Navigating Cell and Gene Therapy: Insights and Challenges with Dr. Bruce Levine 34:42

לפני 29 weeks34:42

34:42

Send us a text How do you navigate the complexities of manufacturing cell and gene therapies that are tailored to individual patients? Find out as we sit down with Dr. Bruce Levine from the University of Pennsylvania to unpack the intricacies of clinical research in this groundbreaking field. From the unique emphasis on chemistry, manufacturing, and controls (CMC) to the logistical hurdles of sourcing and modifying patient-derived cells, Dr. Levine offers an expert's perspective on the challenges and advancements that set these therapies apart from traditional drugs. We also shine a light on the vital role of the International Society for Cell and Gene Therapy in driving forward these innovative treatments. In another riveting segment, we delve into the recent FDA investigation into cases of T-cell malignancies following CAR T-cell therapy. With data gleaned from voluntary reporting databases, we scrutinize causality, immortal time bias, and the need for improved reporting standards. Dr. Levine shares his thoughts on the importance of thorough patient follow-up and effective communication of risks and benefits. We also explore the evolution of cell and gene therapy, tracing Dr. Levine's journey from his early days in immunology research to his pivotal role in shaping the field. This episode is a must-listen for anyone interested in the dynamic and ever-evolving world of cell and gene therapy. ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

1
Reconnecting with Purpose: Transforming Job Satisfaction and Patient Care in Life Sciences with Jill Donahue 40:53

לפני 32 weeks40:53

40:53

Send us a text What if re-engaging with your purpose could revolutionize your job satisfaction and mental health? Join us for our conversation with Jill Donahue, a leader in life sciences whose personal journey through psychology, behavioral science, and a profound personal tragedy has fueled her mission to improve communication and trust within the healthcare community. Jill opens up about how these experiences led her to create initiatives like her book "A Dose of Inspiration" and the Aurora Project, both aimed at fostering a deeper sense of purpose among life sciences professionals. Step into the world of Johnny, a shuttle bus driver in Phoenix, who discovered how focusing on spreading happiness could significantly transform his work experience and income. This inspiring tale serves as a powerful reminder that a purpose-driven mindset can make a difference in any role, from healthcare to pharma and beyond. Jill and our hosts discuss practical strategies for connecting with your "why" and engaging audiences during presentations through personal motivations and stories, highlighting how genuine connections can enhance both professional and personal experiences. The conversation shifts to the pharmaceutical industry’s much-needed transformation towards patient partnership. Jill passionately advocates for a shift from product-centric to patient-centric narratives, emphasizing the importance of presenting treatment options and building expertise in specific disease states. This approach, she argues, not only improves patient care but also makes the role of pharma representatives more fulfilling. Tune in to hear Jill's excitement about her book, "A Dose of Inspiration: 100 Purpose Stories from Pharma Leaders," and her dream of igniting a sense of purpose in everyone within the industry. Notes: A Dose of Inspiration: 100 Purpose Stories from Pharma Leaders can be found on Amazon or as a free download at www.excellerate.ca/freebook More information about The Power of Purpose can be found here Jill can be reached here on LinkedIn ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

1
Revolutionizing Clinical Trials: The Promise of AI and Predictive Analytics with Vinodh Balaraman 29:40

לפני 33 weeks29:40

29:40

Send us a text When nine out of ten clinical trials don't cross the finish line, it's time to ask tough questions and seek innovative answers. That's exactly the journey we embark on with Vinodh Balaraman from KolateAI in our latest podcast episode. Together, we unravel the complex knot of challenges that lead to clinical trial failures, from flawed study designs to enrollment obstacles and the unexpected curveballs thrown by the approval of competitor drugs. But it's not all doom and gloom; we shine a light on the potential of AI to bring about much-needed predictive capabilities, paving the way for trials that are as efficient as they are effective. Ever wondered how big data and predictive analytics could be the game-changers in drug development? Our conversation takes a deep dive into the role of AI in forecasting how patients will respond to treatments, potentially transforming the hit-and-miss nature of clinical trials into a targeted approach. We discuss the transformative power of a SaaS business model and shared knowledge bases, considering how they could overhaul the pharmaceutical landscape. Despite the industry's tentative steps toward data sharing, we explore the gradual shift as medical professionals begin to wield these cutting-edge tools to make smarter, data-driven decisions. Bringing a dose of humanity to the tech talk, I share my personal motivation stemming from a family member's battle with rheumatoid arthritis—a catalyst for my commitment to pushing the envelope in clinical development. The episode concludes with a reflection on how AI stands on the brink of revolutionizing medical affairs and real-world studies, but is often met with skepticism. By fostering a culture open to change and innovation, we envision a future where clinical trials become more successful and efficient. Join us as we discuss the landscape of trials and the untapped potential that KolateAI brings to this critical field. Guest: Vinodh Balaraman ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

1
Exploring Patient-Centric Innovations in Digestive and Women's Health with Ariadna Maso 38:24

לפני 39 weeks38:24

38:24

Send us a text Navigating the tumultuous sea of inflammatory bowel disease (IBD) is no small feat, and Ariadna Maso of Sanno Health is our compass on this voyage. As the mastermind behind a company that's reshaping how we understand and manage gut health, Ari shares her intimate understanding of the patient's struggle, from the stinging uncertainty of diagnosis to the often overlooked psychological toll. Our conversation goes beyond the standard medication narrative and into the realm of holistic care, where anti-inflammatory diets and mental health support take center stage. Ari's insights into ongoing research illuminate a path for integrating these lifestyle modifications into patient care, offering a beacon of hope for those navigating these often-rough waters. When it comes to personalizing patient care, digital biomarkers are the wayfinders charting a course through the previously uncharted territories of healthcare. But the journey is fraught with challenges: data diversity, operational hurdles, and the sheer volume of information from tools like wearables. In this episode, Ariadna navigates us through these operational storms, detailing how Sanno Health evolved from an app into a comprehensive platform that's not only tracking patient health but is actively engaging them in their treatment. We also probe into the stark disparities between industry perceptions of patient-centric care and the realities patients face, unveiling the transformative potential of incorporating patient feedback directly into clinical trial designs. Join us as we explore the diverse therapeutic landscapes that stand to benefit, including digestive health and the burgeoning realm of women's health, and the far-reaching implications of data-driven medical advancements. Guest Ariadna Masó ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

1
Large Language Models in Clinical Trials with Eirini Schlosser 34:17

לפני 47 weeks34:17

34:17

Send us a text This week we sit down with Erini Schlosser, CEO of Dyania Health, and chart the pioneering advancements in large language models within healthcare. This episode promises to reveal how the shift from simple entity recognition to sophisticated reasoning models has revolutionized drug discovery and the curation of electronic medical records, all while unpacking the challenges of data privacy, computational demands, and the hunt for specialized AI talent. Discover the fusion of technology and medicine where the collaborative potential for real-world data utilization in evidence-based studies emerges as a beacon for innovation amidst the complexities of modern clinical trials. As we explore the parallels of AI training to medical education, you'll be enthralled by stories of AI models undergoing meticulous fine-tuning by our in-house physicians, echoing the rigorous journey of medical residents. Irene lifts the veil on her own path, which led from a lineage steeped in medicine, through the worlds of biochemistry and investment banking, to the groundbreaking integration of NLP into healthcare at Dyania Health. Our conversation shines a light on the future of automating clinical research, where AI not only answers but justifies with evidence, promising an unprecedented era in the management and interpretation of medical data. Tune in for an intimate look at the challenges overcome and the milestones achieved in teaching machines to navigate the intricacies of human health. Guest: Eirini Schlosser ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

1
The Evolution of Clinical Trials Through Wearable Devices with Wessam Sonbol 33:13

לפני 48 weeks33:13

33:13

Send us a text Uncover how the seamless fusion of wearables with patient data is revolutionizing clinical trials in our latest conversation with Wessam Sonbol, the Founder and CEO of Delve Health. We navigate the transformation from cumbersome paper reporting to the sophisticated use of Patient Reported Outcomes and the continuous insights wearable technology offers. As we dissect the benefits and hurdles of this evolving data landscape, you’ll get an insider perspective on the intricacies of managing vast health metrics and setting benchmarks for impactful analysis. Plus, Wessam shares his knowledge on the reliability and strategic employment of wearables in clinical research, offering a glimpse into how these devices are altering the way we approach health monitoring. In our discussion, the concept of 'wearables as a service' emerges, a trailblazing model crafted by Delve Health to elevate the clinical study experience for both patients and researchers. Wessam delves into the rigorous process of selecting wearables that align with trial goals, sharing how gadgets like Fitbits undergo efficacy evaluation. Be prepared to discover how innovations like automated compliance and concierge teams are mitigating study site burdens and boosting data quality. We also tackle the broader spectrum of challenges and advancements in clinical research, contrasting the swift advancements in wearable tech with the methodical progress of drug trials. Join us to envision a future that prioritizes patient-centric care, reduced tool burden, and heightened automation, and don't miss Wessam's call to action for ongoing dialogue that aims to reshape the patient experience in the health and life sciences arena. Guest: Wessam Sonbol ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

1
Innovating Clinical Trial Design with Pierre Colin and Boaz Adler 1:07:03

לפני 50 weeks1:07:03

1:07:03

Send us a text Unlock the secrets of clinical trial design with industry experts Pierre Colin and Boaz Adler as they join us for a deep dive into the early-stage planning that shapes the future of pharmaceuticals. They provide a look at the collaboration between clinicians, statisticians, and regulatory experts that's critical for determining the right patient populations, dosages, and study endpoints. With their guidance, we explore how statistical software and scenario planning play pivotal roles in estimating patient numbers, study durations, and costs, transforming clinical trial design into a fine art. As we navigate through the evolution of statistical methods, our guests share their insights on the need for adaptability in clinical trial designs, especially in areas like oncology with unique endpoints such as overall survival. They spotlight the importance of cross-company collaborations and direct FDA discussions in driving innovations. The conversation also illuminates the ever-growing contributions of R-coding, a testament to the individuality of each study, allowing for customized and cutting-edge approaches to trial design. To wrap up, we spotlight the dynamic landscape of drug development where biostatistics paves the way for groundbreaking designs. Our guests emphasize how feedback from scientific communities influences new methodologies, shifting the focus from traditional success measures to concepts like assurance and power in the promising zone. They also highlight the invaluable role of Bayesian designs, as exemplified by COVID-19 vaccine trials, in ethically accelerating drug development. As we close, remember that this field is ripe with diverse opportunities, and we invite you to reach out with your curiosities and follow-up questions. Join us for this episode that's not just about the science of trials, but the transformation they undergo, ensuring the journey of drug development continues to revolutionize patient care. Guests: Pierre Colin: https://www.linkedin.com/in/pierre-colin-11139028/ Boaz Adler: https://www.linkedin.com/in/boazadler/ ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

1
Mastering the Art of Clinical Trial Partnerships: Insights from Jason Gubb on Outsourcing and Co-Creation 36:36

לפני 51 weeks36:36

36:36

Send us a text Embark on a journey through the dynamic landscape of clinical trial outsourcing with Jason Gubb, the co-founder of ClinOps Clarity and Emergent Teams. As we navigate the historical shift from predominantly in-house operations to the intricate web of external partnerships, Jason sheds light on the critical decision-making processes that shape the pharmaceutical and biotech industries. Grapple with the challenges and opportunities presented by R&D budget constraints and learn how emerging biotech firms are steering through fluctuating funding currents. Discover a world where the right choice of vendors can make or break a clinical trial, and how companies balance the scales of internal project management and external collaboration. With Jason's sage guidance, gleaned from his tenure at GSK and his entrepreneurial ventures, we dissect the artistry behind cultivating successful clinical trial partnerships. He shares insights on the transformative effects of smart decision-making and the vigour of challenging established practices while ensuring that every partnership is rooted in open communication and shared goals. Jason also illuminates the impact of a patient-focused ethos and addresses the nuances between co-creation and mere collaboration. So tune in to expand your understanding of the pivotal role that culture and relationships play in shaping the outcomes of clinical trials and to witness the emergence of alliances that are as resilient as they are innovative. ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

1
Breaking Barriers for Diversity in Clinical Trials with Sam Whitaker 41:34

לפני 1 year41:34

41:34

Send us a text In this conversation with Sam Whitaker, we delve into the pivotal issues faced by underrepresented groups—particularly those from lower-income backgrounds—highlighting the disparity in current demographics and the consequences it bears on the reliability of drug efficacy and safety data for diverse populations. We go beyond the surface to examine the complexities surrounding compensation for trial participants, debunking the myth that stipends serve as an incentive and instead revealing the net financial loss many endure. With Sam's expertise, we explore why the current compensation structures pose significant barriers for those in lower-income brackets. Sam Whitaker's insights prompt us to question the ethical responsibilities of Institutional Review Boards (IRBs) in safeguarding participant welfare, particularly in terms of payment evaluation. The conversation scrutinizes the pressing need for standardized compensation practices, emphasizing the potential financial harm and barriers these present to willing participants. Our discussion raises awareness about the delicate balance between the pursuit of scientific knowledge and the imperative of ethical consideration in the realm of human testing. Lastly, we shine a light on the legislative efforts aiming to dismantle the financial hurdles that deter diverse participation in clinical trials. Tax implications for low-income participants and the risks to their welfare benefits take center stage, with bipartisan support emerging as a beacon of hope in the push for reform. Sam shares the impactful work being done through Mural Health, including the Portrait Project, which seeks to humanize and democratize the clinical research process. Join us to understand how these initiatives are not just transforming patient involvement, but reshaping the landscape of clinical trials for the betterment of all. Guest: Sam Whitaker Mural Health ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

1
“Adaptive Clinical Trial Design: Large-Scale Study Simulation to Design for Results with Boaz Adler 38:34

לפני 1 year38:34

38:34

Send us a text This week we speak to Boaz Adler from Cytel's Software Division. This episode promises to illuminate the intricacies of trial design through the lens of Monte Carlo simulation, revealing how this potent approach crafts trials resilient to a myriad of scenarios. Boaz delves into the pivotal roles of interim monitoring and strategic market positioning post-trial, offering a masterclass in the art of clinical trial conception that withstands the test of uncertainty. As we navigate the vast landscape of clinical trial simulation, the topic of scale takes center stage. The conversation orbits around pioneering software platforms like Solara and East, which are reshaping trial design by integrating a kaleidoscope of variables and uncertainties. This episode pulls back the curtain on the potential of cloud computing to revolutionize simulations, providing a glimpse into the future where clinical trials are executed with unparalleled speed and precision. With Boaz' expertise, we ponder the industry's readiness to trust probabilistic outcomes and how regulatory bodies are warming up to the simulation-based approaches that these software platforms enable. Finally, we bridge the gap between biostatistics and market access, highlighting the increasing influence of health outcomes research on clinical trial design. The discourse delves into the balancing act of incorporating quality of life measures for regulatory and reimbursement decisions, the finesse required to blend standard software with bespoke coding, and the imperative of enhanced inter-departmental synergy. My own path to life sciences underscores the episode's reflective tone, leading to a broader examination of Cytel's extensive contributions to the field, from their roots in Monte Carlo simulation software to a comprehensive suite of services that spans the full spectrum of statistical programming and evidence-based research. Join us for this enlightening episode to gain an insider's perspective on the dynamic confluence of biostatistics and pharmaceutical innovation. Guest: Boaz Adler ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

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