#71: Heike Schoen - How To Rescue Your Clinical Trial When at Risk to Fail

2022-03-28

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Did you know that almost 90% of all product ideas fail in clinical trials? 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:Strategic considerations for setting up a clinical trialInhouse vs Outsourced Clinical Study ManagementWhy clinical trials failSteps to getting your clinical trial back on t...

Did you know that almost 90% of all product ideas fail in clinical trials?

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:

Strategic considerations for setting up a clinical trial
Inhouse vs Outsourced Clinical Study Management
Why clinical trials fail
Steps to getting your clinical trial back on track
Future trends of clinical trials

Who is the expert in the show?
Heike Schön, Lumis International GmbH with more than 25 years of experience in international clinical research and drug development.

📞 Book a meeting here: Link

📰 Article: Medium

Youtube: https://youtu.be/r0qphO8Qs3o
Podcast notes: Link

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 succ