Beginner's Mind

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Did you know that almost 90% of all product ideas fail in clinical trials? The most obvious reason that a clinical trial fails is lack of efficacy.

Surprising to me was that lack of efficacy doesn't seem to be the main reason why clinical trials fail in the first place. Other factors are at play, and most of them are manageable risks when the right team is at work.

In this episode, we talk about:

• Strategic considerations for setting up a clinical trial
• Inhouse vs Outsourced Clinical Study Management
• Why do some clinical trials fail?
• Steps to getting your clinical trial back on track
• Future trends of clinical trials
• and much more

Who is the expert in the show?
Heike Schön is the Managing Director and Co-Founder of Lumis International GmbH and Lumis Life Science Consulting GmbH.

She has more than 25 years of experience in leadership positions in international clinical research and drug development.

📞 Book a meeting here: Link

Youtube: https://youtu.be/r0qphO8Qs3o
Shownotes @ Podcastnotes: tbd

Timestamps:
(00:00) Intro
(02:25) Who Is Heike Schön, Lumis International and Lumis Consulting?
(04:20) Topics in the Episode
(04:30) Kick-Off
(05:00) Background to Lumis International and Heike Schön
(10:20) When is the Right Time to Start with the Planning of a Clinical Trial?
(12:10) The Role of a Sponsor of a Clinical Trial
(14:30) Who is Responsible for the Clinical Trial as a Sponsor?
(16:55) When Should a Company Start to Implement Clinical Trial Management in the Organisation?
(18:30) Funding Requirements for Clinical Trials
(20:00) The Reality of Inhouse and Outhouse Clinical Trial Management
(22:15) What to Think About When Planning Oversight Management
(25:00) Relationship and Culture Management in Clinical Trials
(27:25) Budget and Ressource Requirement for Clinical Trials
(28: 45) 3 Steps to a Successful Clinical Trial 
(30:40) The 3 Main Reasons Why Clinical Trials Fail
(33:30) Considerations for Patient Enrollment as a Key Success Factor for Clinical Trials
(37:30) … and when enrolment fails, what are the steps to rescue the trial?
(42:45) Do Inhouse Studies Require Rescue?
(44:30) How to Rescue a Clinical Trial
(48:30) Root Cause Analysis as a Starting Point to Rescue a Trial
(52:25) Preventive Measures to Avoid Failure Early on
(53:30) How Important is Leadership in a Clinical Trial?
(56:30) The 3 Main Reasons to Stop a Clinical Trial – The Point of no Return
(59:00) How are the Cost Calculated for Rescue Study Management?
(01:00:15) Planning of a Clinical Trial – A Key Aspect of a Successful Trial
(01:02:15) How to Plan Realistic Timelines and Numbers
(01:07:15) The Role of Feasibility Studies in Clinical Trials
(01:09:30) How Clinical Trial Management Evolved in the last 30 years
(01:11:15) Upcoming Trends in Clinical Trial Management
(01:13:15) Decentralized Clinical Trials
(01:15:00) Artificial Intelligence And Big Data in Clinical Trial Management
(01:17:55) The Digital Twin
(01:19:15) The Human Factor and Leadership in Clinical Trial Management
(01:21:10) The Patient in Clinical Trials
(01:22:55) Planning and its contribution to clinical trial success
(01:26:55) Summary of What to Do When Clinical Trials Fail
(01:28:35) When is the Right Time to Add a Rescue Team to the Clinical Trial?
(01:31:00) A Risk Management Plan for Clinical Trials
(01:32:00) How to Cont

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