Session (CTI)

Purpose: • The goal of this workshop will be to provide an overview of the value of real world studies (RWS) for clinicians while identifying gaps in RWE knowledge and opportunities for improvement. Description: The following topics and questions will be covered during the session: • What is the role of RWE in clinical practice:? o Transition from ‘ideal” RCT study subject to real world patient: - Understanding factors that provide discrepant results when comparing RCTs to RWS : •Demographics •Comorbidities •Concomitant medications •Access to care •Patient concerns and preferences •Compliance with treatment •Adherence to management regimen (example diet, habits etc.) - Distinguish between modifiable and non – modifiable factors that affect patient outcomes: •Focus on modifiable factors that can yield maximum benefits to each patient o Knowledge gaps addressed by RWS: - Patient subgroups - Factors affecting response to treatment in clinical practice - Safety and rare adverse events - Comparative effectiveness - Patient satisfaction and preferences The speakers will present examples of RWS from specific therapeutic areas: oncology, autoimmune diseases (dermatology, gastrointestinal and rheumatology), hypertension and diabetes. Interactive Component: •Audience will be presented with hypothetical situations where clinical decision making can be influenced by RWE to supplement results of RCTs. o Audience will be polled on the clinical practice decision and will participate in a discussion about how RWE may have affected the decision. o Audience will participate in a discussion on the barriers (hesitations) to incorporating RWE in clinical decision making. •Audience will be polled about the value of RWE for: o Individual patient management o Modification of clinical practice patterns o Health care policies o Reimbursement decisions