This course will look into methodologies of patient partnering and patient engagement before and during the design of your clinical trial.
The focus will be on remote / decentralized trials. Still, the conclusions will be transferable to most other aspects of patient input into clinical trial design.
The course will navigate you through materials, methodologies, procedures and tools that can be used in real-practice to follow recent FDA guidance for PFDD (patient focused drug development) and recommendations of the EMA.
The following key elements will be part of the programme:
- ‘Patient focused drug development’ regulatory landscape
- Challenges with clinical trial designs and how to overcome these with Patient Engagement
- Differentiating between hype and actual patient value of remote/decentralized parts of clinical trials
- Defining different methodologies to obtain practical patient insights to improve decentralized/hybrid designs and conventional designs
- Best practice and typical traps
- Case studies
Clinical Operations, Clinical Development, R&D Strategy, Patient Affairs/Relations, Patient Experts, Medical Affairs, R&D Project Management belonging to pharmaceutical, biotech companies and academia.
Basic knowledge on clinical development and in particular clinical trials is preferred.
In case of no patient engagement experience, following the course Introduction to Patient Engagement in Clinical Drug Development is advised, but not mandatory.
Case studies, procedures and methodology tools for use in practice
Moderated exchange of practical experience regarding challenges and solutions
Interactive training course, to put learning into practice