Congress Aims

Design the Best Study

Choose the best end point study that provides answers and that has a high probablilty of achievement
Design studies that provide high quality data and can be used for decision making
Include criteria that enable fast recruitment of patients; Choose design elements and inclusion/exclusion criteria that increase the probability of success for the study
Ensure the best retention rate

Improve Regulatory Process; Better understanding of how to collaborate with regulatory authorities

Help the regulatories develop a fast track approval for clinical studies on all levels (EMA/FDA, Country level, Institute level)
Encourage off label to label studies
Enable collaboration between regulatories, payers, industry and academia, to ensure high probability of successful drug marketing

Involvement of Digital Medicine

Design RCT’s using electronic charts
Use electronic chart to study real world efficacy and safety of drugs and device

Power Post-Marketing Surveillance

Ensure Proper Data Collection
Improve Critical AE reporting