Co-Chairs:
Marc Berger, MD
Vice President, Real World Data and Analytics
Pfizer
New York, NY, USA
Daniel Mullins, PhD
Professor, Pharmaceutical Health Services Research
School of Pharmacy University of Maryland
Baltimore MD, USA
Leadership Group:

Diana Brixner, RPh, PhD , University of Utah, Salt Lake City, Utah, USA
Hans-Georg Eichler, MD, EMA, London, UK
Wim Goettsch, PhD, EuNetHTA JA3, Diemen, The Netherlands
David Madigan, PhD, Columbia University, New York, NY, USA
Harold Sox, MD, PCORI, Washington, D.C., USA
Rosanna Tarricone, MSc, PhD, Bocconi University, Milan, IT
John Watkins, MPH, PharmD, Premera Blue Cross, Mountlake Terrace, WA, USA
Richard Willke, PhD, ISPOR, Lawrenceville, NJ, USA

Co-Chairs:
Sebastian Schneeweiss, MD, ScD
Division of Pharmacoepidemiology and Pharmacoeconomics
Brigham and Women’s Hospital, Harvard Medical School
Boston MA, USA
Shirley V. Wang, PhD, ScM
Division of Pharmacoepidemiology and Pharmacoeconomics
Brigham and Women’s Hospital, Harvard Medical School
Boston MA, USA
Leadership Group:

Jeffrey Brown, PhD, Department of Population Medicine, Harvard Medical School, Boston MA, USA
Ian Douglas, PhD, London School of Hygiene and Tropical Medicine, London, UK
Joshua J. Gagne, PharmD, ScD, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Harvard Medical School, Boston MA, USA
Olaf Klungel, PhD, Department of Pharmaceutical Sciences, University of Utrecht, Utrecht, Netherlands
Jeremy A. Rassen, ScD, Aetion Inc., New York, NY, USA
Liam Smeeth MSc, PhD, London School of Hygiene and Tropical Medicine, London, UK

Note: the ISPOR and ISPE paper co-chairs will participate in both papers.
Objective:

This joint Special Task Force will focus on:

  1. good procedural practices for the conduct of RWE studies that can enhance the confidence of health care decision makers to factor these studies into their decision-making; and
  2. good practices to improve reporting details in a structured way so that database studies become reproducible as a step to instill confidence in RWE.
Background:

The volume and diversity of real-world data (RWD) available for analyzing health care decision-making has been growing prodigiously of late. While randomized clinical trial (RCT) evidence remains the gold standard for treatment efficacy evaluation, the potential and interest is also growing for converting RWD into real-world evidence (RWE) by a wide variety of stakeholders through careful analysis and interpretation of RWD to inform a variety of other health care decisions. Nevertheless, the standard concerns about RWE – such as lack of randomization, data quality, potential for spurious results due to data-mining, and the complexity of coding that can make reproducibility of results difficult – continue to cast shadows on its credibility and use among decision-makers of all types, particularly regulatory decision-makers.

Full details can be found in the "Revised Joint ISPOR-ISPE STF proposal"

Activities:

22nd Annual International Meeting, May 20-24, 2017, Boston, MA, USA

JOINT ISPOR–ISPE SPECIAL TASK FORCE ON REAL WORLD EXPERIENCE IN REGULATORY DECISION MAKING: WILL TRANSPARENCY IMPROVE ACCEPTABILITY? (Invited Issue Panel) – Monday, May 22, 11 am - 12 noon

Released Presentations »

IMPROVING REPRODUCIBILITY AND ROBUSTNESS OF EVIDENCE FROM LARGE HEALTH CARE DATABASES WITH SPECIFIC REPORTING GUIDANCE (workshop) – Tuesday, May 23, 11 am - 12 noon

Released Presentations »


RWE in Health Care Decision Making Initiative