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