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Did you ever wonder what it takes to bring a new medical product from the drawing board to the patient's bedside? Developing a new therapeutic, medical device, or diagnostic tool to help patients with their illnesses is not straightforward. In fact, 90% of product ideas fail in clinical trials, not because of safety and efficacy reasons.

Clinical trials are crucial to every scientific development in the healthcare field. The pandemic has brought clinical trials to the forefront of the news, with daily articles about the clinical development of vaccines and novel medications. The media often portrays clinical trials as simple, but the reality is that they are incredibly complex tasks.

Consider the numbers involved in the Pfizer/BioNTech Phase 3 clinical trial. 43,000 people were enrolled in that study alone. As of November 2020, over 6,274 Covid-19 related clinical trials were listed on the WHO site and clinicaltrials.gov. While not all trials require such a large number of participants, it is still a massive undertaking. For example, the Moderna clinical phase 2/3 trial only requires 4,000 participants. But still, to complete all 6,274 trials, over 1.5 million people would need to be enrolled. This number does not include the study personnel, scientific and development personnel, and regulatory personnel required to conduct and conclude the trial.

To shed some light on the complexities of clinical trial management, I have organized a podcast with Heike Schön, CEO of Lumis International. Heike has over 25 years of experience in international clinical research and drug development leadership positions. She deeply understands the clinical drug development processes and regulatory requirements, from first-in-human to market access. Heike and Lumis International have been working to bridge the gap between biopharmaceutical and medical device companies and the European market, providing legal and data representation services and regulatory consulting to companies outside Europe.

Here are three key takeaways from the podcast with Heike Schön:

Start Early with the Planning: Clinical trials are a massive leadership and management exercise, and it's important to start early with the planning. According to Heike, the more people involved in the trial, the more time the leaders must spend putting together the plan and aligning everyone toward the goal. The teams of the study sites must be aligned, and it takes time and effort to keep everything moving forward. A well-crafted plan is a key to success in clinical trials.
Organize the Necessary Structures Early: To reduce the complexity of the project organization, Heike emphasizes the importance of setting up the necessary structures early on. Clinical trials require human beings to deliver the results, and it's crucial to align the people, processes, and protocols early on to ensure a smooth trial.
Managing Expectations is Key to Success: According to Heike, managing expectations is the key to success in clinical trials. When you consider all the stakeholders involved in a trial - investors, public funding organizations, scientists, CROs, personnel at the study sites, and more - aligning expectations can take out a lot of potential friction from the trial.

In conclusion, clinical trials are complex tasks that require careful planning, organization, and management. Heike Schön and Lumis International have the expertise and experience to help companies navigate the challenges of clinical trial management and bring their products to the European market. Join me for this podcast to learn more about the challenges and opportunities in clinical trials and how to succeed in the rapidly evolving world of healthcare.

Podcastnotes

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) Contact

Thanks, Heike Schön

If you enjoyed this session with Heike Schön, let er know by clicking on the link below and sending her a quick note on social media:

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NanoTemper - Tools for Challenging Biophysical Characterizations

From Blue Collar to Biotech: The Incredible Journey of NanoTemper CEO Philipp Baaske and His Search for Investment Amidst Financial Crisis."

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#71: Behind the Scenes of Clinical Trials