Episoder
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Meet Jan Poleszczuk, a mathematician turned healthcare innovator and a CTO of CliniNote. In this episode Maya and Jan talk about:
- The top 3 challenges hindering the quality of RWD
- How CliniNote is helping doctors generate quality data while simplifying their workflow
- The potential of RWD in clinical trials
Tune in to explore the good, the bad, and the ugly of Real-World Data and how innovators like Jan Poleszczuk are working to unlock its full potential to improve patient care and drive healthcare innovation.
Follow Maya on LinkedIn: https://www.linkedin.com/in/mayazlatanova/
Follow Jan on LinkedIn: https://www.linkedin.com/in/jan-poleszczuk-70200117/Learn more about CliniNote: https://clininote.com/
(00:00) - Introduction and Background(02:58) - The issues with RWD(06:47) - The Importance of Medical Notes in Real-World Data(11:34) - Automating Transcription of Doctors' Notes(17:09) - Empowering Doctors to Generate High-Quality Data(19:28) - Focusing on Doctors' Jobs to Improve Real-World Data(21:26) - Conclusion and Future of Real-World Data -
Meet Esther Howard, Mental Health Advocate, Researcher and CEO of Bezyl. In this conversation, Esther shares her unique perspective on the importance of understanding patient journey, not just as a scientific necessity, but as a fundamental human duty for researchers. Esther explores the three critical prongs of patient journey: standard of care, the specifics of the patient's disease, and the often-overlooked aspects of their daily lives. She emphasizes the need for researchers to look beyond the protocol and embrace a more holistic view of patients' experiences, arguing that by embracing our human duty to understand and empathize with patients' experiences, we can not only advance scientific knowledge but also create a more compassionate and patient-centric approach to clinical research.
(00:00) - Introduction and Background(03:22) - Understanding the Patient Journey(11:38) - The Importance of the Patient Journey(18:42) - Patient Needs and Perception(22:22) - The Role of Real-World Data(28:57) - Implications for Clinical Trials
Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Follow Esther Howard: https://www.linkedin.com/in/esther-howard-7352b3b3/
Learn more about Bezyl: https://www.linkedin.com/company/bezyl/ -
Manglende episoder?
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Meet Heidi Floyd, a breast cancer survivor, patient advocate, and champion for transforming clinical trials through authentic patient engagement. In this powerful episode, Heidi shares her remarkable journey of navigating cancer treatment while pregnant.Heidi emphasizes the critical importance of building meaningful relationships between patients, healthcare providers, and clinical trial teams. She discusses the common reasons patients may choose to quit clinical trials and the need for greater understanding and support of patient circumstances.
(00:00) - Introduction and Heidi's Breast Cancer Journey(04:06) - Becoming a Patient Advocate(06:36) - The Importance of Patient Engagement(10:27) - Addressing Financial and Logistical Barriers(15:28) - The Role of Technology in Patient Engagement(19:28) - The Choice for Pregnant Women in Clinical Research
Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Follow Heidi Floyd: https://www.linkedin.com/in/heidi-floyd-b89b179/ -
Meet Travis Caudill, Vice President of Feasibility and Clinical Informatics at ICON, a seasoned expert in the world of clinical trial optimization. Discover how Travis and his team are navigating the complexities of trial feasibility—using data to optimize site selection, understanding local patient journeys, and anticipating changes in the standard of care.Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
(00:00) - Introduction and Background(04:34) - The Access to Data and Tools for Analysis(08:57) - The Focus on Optimizing Clinical Trials(13:01) - The Impact of Data on Geographical Selection(15:46) - The Importance of the Patient Journey(20:07) - Engaging Investigators and Leveraging Data(21:54) - Predicting Clinical Trial Success(24:06) - Simplifying Decision-Making(25:56) - Protocol Variability(27:55) - The Need for Quick Decision-Making(31:52) - Building Comprehensive Platforms(34:42) - Balancing Experience and Protocol(36:56) - Global Access and Data Penetration
Follow Travis Caudill: https://www.linkedin.com/in/feasibility/ -
Ilknur Lechthaler is an expert in clinical operations, research, and startup investments. Ilknur discusses how the industry's awareness of the significance of country-specific standard of care has evolved over the past decade. Together with Maya they dive into the practical aspects of country selection and the factors that influence decision-making, such as regulatory requirements, timelines, and budget constraints.
Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Follow Ilknur Lechthaler: https://www.linkedin.com/in/ilknur-lechthaler/ -
Meet Todd Georgieff - a veteran in drug development and clinical operations with expertise in optimizing global trials. In this episode, Todd and Maya explore the critical aspects of protocol optimization and patient burden quantification. How does understanding local standard of care impact trial success? What are the ethical implications of providing treatments in different healthcare systems? Todd shares insights on these questions and more.
(00:00) - Introduction and Background(03:12) - Understanding the Local Patient Pathway and Standard of Care(10:54) - Making Clinical Trials More Attractive to Patients(19:29) - The Implications of Not Considering Standard of Care(23:37) - Quantifying Patient Burden in Clinical Trials(28:38) - Feasibility of Quantification Method for Global Trials(37:47) - The Future of Clinical Trials: Data Interoperability(41:41) - Predicting the Next Game Changer for Clinical Trials
Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Follow Todd Georgieff: https://www.linkedin.com/in/toddgeorgieff/ -
Meet Kasia Harris - an expert in clinical trial feasibility and planning with experience in both CRO and Pharma. bringing valuable insights into the complexities of global healthcare systems. In this episode, Kasia and Maya delve into the critical role of understanding local standard of care in clinical trial success. They explore feasibility assessments, protocol, country, and site-specific considerations. Kasia highlights how standard of care impacts patient enrollment, country and site selection, and overall trial efficiency. This episode is a must listen for anyone involved in planning or conducting international clinical trials.
Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/Follow Kasia Harris: https://www.linkedin.com/in/kasia-harris-md-16316b44/
(00:00) - Introduction and Background(03:06) - Feasibility Assessment(06:07) - Importance of Understanding the Local Standard of Care(10:40) - Impact of Standard of Care on Patient Enrollment(25:28) - Challenges of Assessing the Standard of Care(27:09) - Standard of Care in Selecting Comparators and Budget Implications -
Meet Annabel de Maria Bosch - the Chief Patient Officer at Alira Health with nearly three decades of experience in patient engagement across the pharmaceutical industry. In this insightful conversation, Annabel shares her unique perspective on the critical importance of understanding the patient journey and its impact on clinical trial success.
Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Follow Annabel de Maria Bosch: https://www.linkedin.com/in/annabeldemaria/
Annabel shares some very curious studies in the episode:1)Stergiopoulos et al., Measuring the Impact of Patient Engagement and Patient Centricity in Clinical Research and Development (2020);
2)Levitan et al., Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI’s Patient Groups and Clinical Trials Project (2018);
3)Getz, Establishing Return-on-Investment Expectations for Patient-Centric Initiatives (2015)
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Meet Joy Milne, a remarkable woman whose unique sense of smell is revolutionizing the world of Parkinson's research. In this episode, Joy shares her personal story of love, loss, and unwavering determination to make a difference in the lives of those affected by Parkinson's, from her groundbreaking work with researchers at the University of Manchester to her advocacy for greater awareness of the challenges faced by women with the disease.
Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
https://www.nytimes.com/2024/06/14/magazine/parkinsons-smell-disease-detection.htmlhttps://www.npr.org/sections/health-shots/2020/03/23/820274501/her-incredible-sense-of-smell-is-helping-scientists-find-new-ways-to-diagnose-di(00:00) - Introduction to Joy Milne and her Advocacy Work(05:40) - Balancing Biotech Work and Caregiving(06:34) - Challenges in Parkinson's Research and Lack of New Medications(10:37) - Differences in Parkinson's Disease between Men and Women(14:18) - Encouraging Early Diagnosis in Parkinson's(16:56) - Variations in Parkinson's Care across Countries(18:43) - The Importance of Patient Engagement in Clinical Trials(21:04) - Challenges in Communication between Researchers and Patient Advocates(23:34) - The Benefits of a Person-Based Approach in Healthcare(25:49) - The Implications of Patient Public Involvement in Research(29:20) - Positive Changes and Future Outlook in Parkinson's Research
Learn more about Joy Milne and her work: -
Meet Ted Trafford - a seasoned clinical research expert with nearly three decades of experience and a passion for driving innovation in the industry. As the Director of Business Development at Probity Medical Research, Ted brings unique insights into the challenges faced by sites, sponsors, and patients in the clinical trial landscape.
Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Follow Ted Trafford: https://www.linkedin.com/in/tedtrafford/Check out Ted's post mentioned in the episode: https://www.linkedin.com/posts/tedtrafford_clinical-trial-marathon-activity-7221841156958011392-tb1e
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Meet Angie Schwab - founder of EZ Research Solutions and a passionate expert in clinical research with a focus on improving trial startup processes. In this episode, Angie and Maya dive deep into the challenges and solutions in clinical trial design and execution. Angie shares her insights on the critical importance of thorough planning, understanding local standards of care, and involving all stakeholders - including patients - in study design. They explore how poor initial planning can set trials up for failure and discuss innovative solutions, including the role of automation and AI in streamlining processes and reducing errors. Angie's vision for the future of clinical trials, emphasizing digitalization, standardization, and intelligent study design from the ground up, offers a compelling look at the evolving landscape of clinical research.
Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
(00:00) - Introduction and Background(02:42) - The Importance of Thorough Planning(07:26) - Understanding the Local Standard of Care(12:38) - Passion for Startup and Problem Solving(17:44) - The Role of Automation and AI(22:41) - The Future of Clinical Trial Startup(25:53) - Moving Towards Digitalization and Standardization
Follow Angie Schwab: https://www.linkedin.com/in/angie-schwab/ -
Meet Begonya Nafria - Head of the Patient Engagement in Research Department at Hospital Sant Juan de Déu Children’s Hospital, championing the cause of paediatric clinical research. In this eye-opening episode, Begonya and Maya delve into the unique challenges of conducting clinical trials for children, especially those with rare diseases. Begonya highlights the startling fact that 95% of rare diseases have no approved treatment, emphasizing the urgent need for increased research investment and improved access to cross-border clinical trials for children and young patients in Europe . This conversation underscores the importance of meaningful patient engagement in designing better trials and ultimately improving care outcomes for children and young people.
Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/Follow Begonya Nafria: https://www.linkedin.com/in/bnafria/
Let’s help Begonya's project on language discrimination in cross-border trials:
If you’re a parent of a child with a rare disease, please collaborate by responding to this survey (available in 22 European languages): https://bit.ly/Survey_Parents_CT
If you’re interested in getting involved as an AMBASSADOR for Begonya’s research project on language discrimination in access to paediatric cross-border clinical trials in Europe, please complete this form: https://bit.ly/CT_Ambassadors
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Dan Sfera really needs no introduction - founder of the Clinical Trials Guru he has been publishing content in the clinical research space since 2010. In this episode, Dan and Maya talk about the challenges of patient recruitment and retention, explore the importance of considering clinical trials as a care option, and the implications of not prioritizing the patient perspective in trial design.
Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/Follow Dan Sfera: https://www.linkedin.com/in/dansfera
(00:00) - Introduction and Background(02:17) - Understanding the Patient Journey(06:01) - Motivations and Expectations of Patients(10:11) - Building trust with the patient(11:44) - Clinical Trials as a care option(19:57) - Implications of Ignoring the Patient Journey -
Meet Robert Joyce - a patient advocate living with multiple chronic illnesses who has turned his experiences into a powerful voice for change in healthcare. In this episode, Robert and Maya explore the complex journey of living with secondary progressive multiple sclerosis, asthma, sarcoidosis, and chronic pain. They discuss the critical importance of including patient voices in clinical trial design, the impact of local standard of care on treatment decisions, and the need for improved communication and transparency in healthcare. Robert's insights shed light on the real-world implications of reimbursement rules, access to treatment, and the diversity of patient experiences in clinical trials.
(00:00) - Introduction and Background(03:43) - The Importance of Including the Patient Voice(07:31) - Challenges in Accessing Treatment and Standard of Care(10:47) - Cultural and Systemic Differences in Patient Engagement(17:26) - Choosing between clinical trial and Standard of care(22:17) - Choosing Between Established Treatment and Clinical Trials(25:20) - The Impact of Standard of Care on Clinical Trial Participation(28:15) - The Need for Transparent Communication and Patient Involvement
Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Follow Robert Joyce:Facebook: https://www.facebook.com/A30MinuteLife
Twitter: https://twitter.com/A30MinuteLife
Blog: https://www.A30MinuteLife.com
Instagram: https://www.instagram.com/A30MinuteLife/
YouTube: https://www.youtube.com/channel/UC4QT-lK_dIzrHLdqGqatZ_g
LinkedIn: https://www.linkedin.com/in/a30minutelife/
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Meet Dr. Lorna Pender - a passionate patient advocate and engagement expert dedicated to amplifying patient voices in healthcare. In this episode, Lorna and Maya explore the vital role of patient engagement in shaping the clinical trial landscape. Lorna highlights how early patient engagement can drive the success of clinical trials and stresses the importance of industry creating accessible, tailored programs that optimize the patient journey.
Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
(00:00) - Introduction to Lorna Pender and Patient Engagement(02:28) - Incorporating Patient Voices and the Local Standard of Care(06:27) - Reaching Diverse Patient Populations(09:46) - The Importance of Understanding the Patient Journey(12:13) - Patient Engagement: Driving Successful Clinical Programs(15:18) - Challenges in Patient Access to Treatment
Follow Dr. Lorna Pender: https://www.linkedin.com/in/dr-lorna-pender-14a458107/ -
Meet Martin Krauss - the CEO of FGK Research, an expert in clinical research with a mission to advance medical treatments and improve patient outcomes. One year after their last episode together, Martin and Maya meet again to talk about the current challenges and developments in the clinical research landscape. Why is there a decline in biotechnology investments globally and how is that affecting the dynamics of the market? What are the challenges in implementing the Clinical Trial Information System (CTIS) in Europe? How is the new Medical Research Act in Germany going to increase efficiency and benefit patients?
(00:00) - Introduction of Martin Krauss(01:43) - Challenges and Decline in Investments in Clinical Research(03:24) - The Challenges and Improvements of the CTIS in Europe(17:05) - The Impact of the Medical Research Act in Germany(28:35) - Promoting Clinical Research and Raising Awareness(33:16) - Making Clinical Trials More Efficient and Cost-EffectiveFollow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Follow Martin Krauss: https://www.linkedin.com/in/martin-krauss-460b489/ -
In this episode, Maya meets Dr. Oren Cohen, who brings more than 30 years of healthcare, research, and clinical development experience to his role, including several senior medical and operational leadership positions at a biotechnology company and another global CRO.
Oren is President at Fortrea Inc which has patient-friendly clinical research units in US and the UK. A hot topic is the unit in Leeds. It’s state of the art as Oren himself describes it. Created with patients in mind, this center is a true example in the industry. Would it resolve the patient recruitment challenge? Has Fortrea paved the way for the future of clinical trials?
Maya and Oren unravel the secret sauce to success and much more in the latest episode. Watch it to learn about:
(0:55) What’s Dr. Oren Cohen’s Professional Experience
(2:37) Why Is Fortrea’s Unit in Leeds So Special
(8:20) How Critical Is the Unit’s Structure to Trials Efficiency
(14:10) Can We Replicate Fortrea’s Success in Leeds Elsewhere
(16:57) Lessons Learned from Building a Patient-Friendly Pharmacological Unit
(22:14) The #1 Thing to Make Trials More Patient-Friendly
Maya Zlatanova, CEO of TrialHub
Dr Oren Cohen, President, Clinical Pharmacology Services and Chief Medical Officer at Fortrea Inc.
(00:55) - What’s Dr. Oren Cohen’s Professional Experience(02:37) - Why Is Fortrea’s Unit in Leeds So Special(08:20) - How Critical Is the Unit’s Structure to Trials Efficiency(14:10) - Can We Replicate Fortrea’s Success in Leeds Elsewhere(16:57) - Lessons Learned from Building a Patient-Friendly Pharmacological Unit(22:14) - The #1 Thing to Make Trials More Patient-Friendly
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Meet Carole Scrafton, a passionate patient advocate and founder of Flutters and Stutters, a patient organization dedicated to improving the lives of those affected by chronic illnesses and rare diseases. In this episode, Carole and Maya explore how Standard of Care shapes the patient journey and experience throughout healthcare, going beyond just access to treatment.
Follow Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
(00:00) - Introduction and Importance of Standard of Care(02:22) - Standard of Care from a patient's perspective(05:50) - Carole's patient journey(11:00) - Factors Influencing the Decision to Join a Clinical Trial(21:49) - Standard of Care Across Countries(25:47) - The Role of Patient Engagement in Clinical Trial Protocol Development
Follow Carole Scrafton: https://www.linkedin.com/in/fibroflutters-655756108/
Flutters & Stutters: https://www.facebook.com/FibroFlutters https://www.linkedin.com/company/flutters-and-strutters/posts/?feedView=all -
In this episode, Maya meets Daniel Schwarz, a co-founder and CIO at the Institute of Biostatistics and Analyses Ltd., a spin-off from Masaryk University, Brno, Czech Republic. With a robust background in biomedical engineering, neuroimaging, and clinical data management, Daniel's work focuses on leveraging advanced data management systems to support significant healthcare projects.
Maya and discuss the following topics:
(1:04) Get to know Daniel Schwarz
(4:34) What’s the secret sauce to a modern EDC
(6:58) Why companies shouldn’t underestimate data management
(8:58) What are the regulatory expectations in data management
(11:04) The main challenge in starting an EDC from scratch
(17:33) The role of AI in EDC and data management
(19:40) What can make trials more patient-friendly
Follow our LinkedIn page for more insights from the world of clinical trials.
Maya Zlatanova, CEO of TrialHub
Daniel Schwarz, Co-Founder and CIO at the Institute of Biostatistics and Analyses Ltd.
(01:04) - Get to know Daniel Schwarz(04:34) - What’s the secret sauce to a modern EDC(06:58) - Why companies shouldn’t underestimate data management(08:58) - What are the regulatory expectations in data management(11:04) - The main challenge in starting an EDC from scratch(17:33) - The role of AI in EDC and data management(19:40) - What can make trials more patient-friendly -
In this episode, Maya meets Moe Alsumidaie, who is the Chief Editor of The Clinical Trial Vanguard. Moe holds two decades of experience in the clinical trials industry.
The Clinical Trial Vanguard is an online platform that provides comprehensive information, analysis, and news related to clinical trials. It caters to a wide audience, including researchers, healthcare professionals, investors, and industry enthusiasts, aiming to keep them informed about the latest developments in clinical trials.
Maya and Moe delve into the world of clinical trials, discussing decentralized clinical trials, the role of AI, regulatory trends, and patient-centric design. Moe shares insights on how to enhance the success and efficiency of clinical trials, emphasizing innovations like digital twins, digital biomarkers, and the need for trust and collaboration in the field.
(02:42) Meet Moe Alsumidaie
(04:29) Is the Momentum for DCT's Dying
(09:02) Current Trends and Future Outlook of Decentralized Clinical Trials
(14:00) The Role of AI in Clinical Trials
(22:13) How Digital BiomarkersTransform Clinical Trials
(25:35) Examples of Patient-Centric Approaches in Clinical Trials
Follow our LinkedIn page for more insights from the world of clinical trials.
Maya Zlatanova, CEO of TrialHub
Moe Alsumidaie, Chief Editor of The Clinical Trial Vanguard
Must-reads from The Clinical Trial Vanguard
Your Guide to Validate Clinical Trial DHTs
The Future of DCTs
Stanford’s New Leap in Personalized Medicine and Trials
Digital Twins: The Future of Clinical Trials
(02:42) - Meet Moe Alsumidaie(04:29) - Is the Momentum for DCT's Dying(09:02) - Current Trends and Future Outlook of Decentralized Clinical Trials (13:00) - The Role of AI in Clinical Trials(22:13) - How Digital BiomarkersTransform Clinical Trials(25:35) - Examples of Patient-Centric Approaches in Clinical Trials
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