Roundtables will happen in two waves: four topics at 1:00 pm, and four topics at 2:00 pm (and will repeat on Fri,, Oct. 2). Each attendee may choose one Roundtable Discussion to attend per day. Space is limited! Register early!HEOR/RWE in Publication Planning & Publication Development – NEWHealth economics and outcomes research (HEOR) data are important in demonstrating product value; and real-world data generation (and the resulting real-world evidence; RWE) is acknowledged by the FDA as important in expanding the use of a drug. Since results of clinical trials are not necessarily representative of real-world use of a newly launched drug, RWE plays an important part in closing the gap between clinical trials and real-world outcomes, and is an increasingly important component of HEOR for pharma companies.
Randomized controlled trial (RCT) data are typically gathered on highly selective populations managed in tightly controlled settings, to answer specific research questions. RWE leverages multiple sources of observational data, including electronic health records, health insurance information, data from product and disease registries, and patient-generated data to determine how a wide range of health care professionals and patients use medicines in diverse settings.
Attendees will hear and discuss how RWE complements evidence from RCTs, to provide a much richer knowledge base around the efficacy and effectiveness of medical interventions. Participants will explore the similarities and differences of planning and developing publications that report results of real-world studies vs those from traditional RCTs.
LEARNING OBJECTIVES:- Understanding and challenging traditional levels of evidence when it comes to assessing, interpreting and evaluating RCT data and RWE data
- Reinforce the concept that RWE complements RCT data, rather than competing with it, and therefore serves to provide a richer evidence base for the healthcare decision-maker.
- Understanding how the diversity of the audience for RWE creates both multiple publication options ..and challenges
- Recognizing the challenges to RWE publication planning
- Differentiate between processes for developing publications based on RWE observational studies vs traditional RCTs
- Identify and understand reporting guidelines for RWE publications, including STROBE, RECORD, MOOSE, etc., and how these compare to the guidelines for RCTs (CONSORT)
