Week 4 online and Testreach exam

Dear course participants,

Last week most of you passed the halfway mark of the online course Question Based Clinical Development – good job!
Some of you still need to finalize week 3 but most are right on track. Be sure to keep up since the course will move on and work will pile up. Week 4 is now available!

QUESTIONS!
In episode 4 Claire initially faces skepticism from Frank and Peter. She came up with some pretty good key questions, but now she needs to incorporate the costs and the probability of answering the key questions successfully. In addition, she needs to define the most optimal order of addressing these key questions and describe this in a clinical development/investigation plan. How will she go about that?

IT IS GETTING REAL
So far, you have learned how to define scientific questions that need to be answered throughout the development of novel medical interventions. We provided you with some generic questions and the QOC, a handy tool to arrange them. Now it’s time to use this approach on real-world cases. Week 4 offers exercises based on two real-world cases. Remember; there is no right or wrong is estimating costs and success probabilities -it is all about where you think development risks lay and how you would need to divide the efforts needed to successfully answer the development questions. Together, these define the optimal path. The QOC is there to help you with that. After creating priority lists of questions, you will need to translate these questions to a development outline and suggest how you would face the uncertainties associated with the case study. After you have completed each case exercise, we describe in the topic “What really happened” the actual situation that took place for these cases and their clinical trials.

DASHBOARD
Have a look at the dashboard to see the activity stream of this course and read back some of the comments made by your fellow participants. It’s valuable to see and react to each other’s assignments and comments! The dashboard is also available for you to answer questions posed by others or react to comments. We aim to provide you with an optimal learning experience. The assignments you will upload will also be discussed in the on campus part of the module in much more detail so don’t forget to sign up for on-campus or on campus extended if you haven’t already! The on campus course will start June 21 2022 in Leiden (4 days) and the extended continues the following week.

TESTREACH
The company Testreach did send an email last week with information about the final exam. You can choose one of the two timeslots for the exam and they provide information about their software. This needs to be installed and tested before the exam. Please do because if you experience any trouble, they can assist in advance. Test the software on the location where you want to do the exam. If you did not receive an email, please let us know by replying to this email.

Enjoy working on the case studies!
Saco