MODULE 1 | Introduction to Patient Engagement in Clinical Drug Development
11 October 2022 from 9:30 am to 1:00 pm CEST
This module will look into the overarching principles, available guidelines and initiatives in Europe on Patient Engagement in Clinical Drug Development as well as an outlook for the future.
It will highlight the importance of Patient Engagement and provides for a basic understanding of Patient Engagement throughout the drug development lifecycle, also following the recent FDA guidance for PFDD (patient focused drug development) and recommendations of the EMA.
- Principles, guidelines & initiatives in Europe (from history to future outlook)
- Overview of best practices / processes to achieve patient relevance in clinical development
- Different roles of patient organizations /communities to drive clinical drug development
- Case studies
MODULE 2 | Patient Engagement and Decentralized Clinical Trial Designs
21 October 2022 from 9:30 am to 1:00 pm CEST
This module 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.
- ‘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
MODULE 3 | Patient Engagement and Clinical Trial Recruitment and Retention
09 November 2022 from 9:30 am to 1:00 pm CET
This module will give insights in the current reality of recruitment and retention challenges for clinical trials and how Patient Engagement can play a key role into (partly) overcoming these challenges. Insights in finding the right balance between technology, digital apps and human interaction to support patients to fit their needs will be addressed.
This course will navigate you through materials, methodologies, procedures and tools that can be used in real-practice to address recruitment and retention challenges for clinical trials.
- Overview of current reality of clinical trial recruitment and retention
- Role of Patient Engagement to improve recruitment and retention
- How to empower, enable and assist patients to fit their needs (appropriate use of technology, digital apps and human interaction)
- Practical guidance and approaches how typical recruitment and retention issues can be resolved in a patient relevant way
- Case studies
MODULE 4 | Patient Engagement and Enhancing Diversity in Clinical Trial Participation
22 November 2022 from 9:30 am to 1:00 pm CET
This module will give insights in the history, current situation and future possibilities and needs regarding diversity in clinical trials. In a step-wise approach several of the challenges associated with diversity in clinical trials will be addressed from a Patient Engagement perspective with practical tools / methodologies that could be implemented.
- History, status quo and outlook for diversity in clinical trials
- Regulatory initiatives to enhance diversity
- Understanding of different types of diversity & associated needs of patients (underprivileged groups, ethnic minorities, age and health sub-groups)
- Practical guidance and approaches towards enhancing diversity in clinical trials through patient / citizen engagement
- Do’s and Don’ts / typical traps for addressing diversity aspects
Other senior staff members from admedicum and internationally renowned patient representatives may be added to the team.
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.
No previous experience in patient engagement is necessary. Basic knowledge on clinical development is preferred.
Case studies, procedures and methodology tools for use in practice.
Moderated exchange of practical experience regarding challenges and solutions.