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Prospective Observational Clinical Studies Good Research Practices

Prospective Observational Studies to Assess Comparative Effectiveness: The ISPOR Good Research Practices Task Force Report

Citation for this report is:
Berger ML, Dreyer N, Anderson Fred, et al. Prospective Observational Studies to Assess Comparative Effectiveness: The ISPOR Good Research Practices Task Force Report. Value Health 2012;15:217-230.

Editorial: Can Observational Studies Approximate RCTs?
Sheldon Greenfield, MD, Health Policy Research Institute, University of California, Irvine, Irvine, CA, USA and Richard Platt, MD, Harvard Pilgrim Health Care Institute, Boston, MA, USA

Translations: » Bosanski

Leadership Group:
Marc Berger MD, Executive Vice President and Senior Scientist, OPTUMInsight, New York, NY
Sharon-Lise Normand PhD, Professor of Health Care Policy (Biostatistics), Harvard Medical School, and Professor, Harvard School of Public Health, Boston, MA, USA
Fred Anderson PhD, Research Professor of Surgery, Director, Center for Outcomes Research, University of Massachusetts Medical School, Worcester, MA USA
Art Sedrakyan MD, PhD, Center for Devices and Radiological Health FDA, Silver Spring, MD, USA
Nancy Dreyer PhD, MPH, Chief of Scientific Affairs & Sr. Vice President, Outcome, Cambridge, MA, USA
Adrian Towse MA, Director, Office of Health Economics, London, England, United Kingdom

Goal:
The goal of this Task Force is to provide good research practices for prospective observational clinical studies that focus on the effectiveness and/or comparative effectiveness of health care interventions.

Background:
Well-designed observational research has an important and valuable role in generating data about comparative effectiveness in the context of real clinical practice settings. Recently, the ISPOR Retrospective Database Analysis Good Research Practices Task Force completed its work with a focus on comparative effectiveness research [See: Defining, Reporting and Interpreting, Approaches to Mitigate Confounding and Bias, and Analytic Methods to Improve Causal Inference.] While many of the issues addressed by this Task Force also may apply to the design and conduct of prospective observational studies, additional issues must be addressed when designing a prospective observational study that is “fit-for-purpose” – that is, it is designed to prospectively test hypotheses about comparative effectiveness in patients recruited to participate in an observational clinical study.  This Prospective Observational Clinical Study Good Research Practices Task Force will focus on good research practices for prospective observational clinical studies, not patient registries. Patient registries may accept all patients with an exposure (e.g. lead) or with specific circumstances (e.g. pregnancy) and for which effectiveness hypotheses are not pre-specified - registries being more commonly used for pharmacovigilance or descriptive purposes. However, it is recognized that when registry data are accessed to examine hypotheses regarding comparative effectiveness, they are indistinguishable from prospective observational studies. Continued...

Work Products:
Prospective Observational Clinical Studies for Comparative Effectiveness Analysis: ISPOR Good Research Practices Report

Activities:
When Seeing is Believing -Comparative Effectiveness: ISPOR Good Research Practices on Prospective Observational Clinical Studies
May 2011 – ISPOR 16th Annual International Meeting, Forum Presentation, Baltimore, MD, USA

ISPOR Task Force Prospective Observational Studies for Comparative Effectiveness
November 2010 - ISPOR 13th Annual European Congress, Forum Presentation, Prague, Czech Republic

The draft final report for member comment is: Prospective Observational Studies to Assess Comparative Effectiveness: The ISPOR Good Research Practices Task Force Report.  The comments to this draft report are: COMMENTS: Prospective Observational Studies to Assess Comparative Effectiveness: The ISPOR Good Research Practices Task Force Report


ISPOR Good Research Practices Index