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