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)

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/

Learn more about Joy Milne and her work:

• https://www.nytimes.com/2024/06/14/magazine/parkinsons-smell-disease-detection.html
• https://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

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

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/
Follow Angie Schwab: https://www.linkedin.com/in/angie-schwab/

• (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

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

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/