Week 1 available online!

Hi everybody,

Just a quick note to let you know that the first week of your course is now available online! Also; have a look at the course dashboard to meet your class.

We’ve had a couple of late entries in the course last week; Welcome to Paul Janssen Futurelab Leiden! Your online course ‘Clinical Development Online’ starts today. My name is Saco de Visser and I will be your teacher in this course.

In this online course, we will not address regulations such as Good Clinical Practice (GCP), nor will we cover how to write a full research protocol for a clinical trial. Instead, we will focus entirely on an approach called Question-Based Clinical Development (QBCD). QBD can help you establish the most efficient route for developing your novel medical intervention such as medicinal products (or drugs), medical devices, and medical nutrition. Furthermore, QBCD supports a rational development of these novel medical interventions.

The QBCD approach is based on Real Option Theory, which is derived from finance options procedures. QBCD begins with the formulation of key scientific questions that must be answered during the development program. In addition, QBCD takes into account the costs associated with answering these key scientific questions, the risk of failure, and the value of the research project. In the course, we will provide you with a robust tool that will help you identify the optimal order in which to address your key questions. You will be introduced to the QBCD approach in a step-by-step fashion through discrete weekly learning objectives.

Be advised to schedule at least 5 hours each week to do assignments (especially in the last 2 weeks), study the course material and discuss topics with your classmates (meet them in your online classroom) and/or with me. This online course works via ‘the content-dripping principle’, meaning each week on Monday, a new lesson will become available. Try to keep up to avoid having to catch up in the end!

I hope you’ll find it a meaningful experience and look forward to reading your assignments and discussing the topics in the next five weeks. Please feel free to contact me at anytime if you need me. We are excited to start the course again with this new group, hope you are too! Hope you will all enjoy this week’s learning activities and let me know if you need any help!

Saco