Newswise — Princeton, NJ—September 15, 2017—The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) announced today the publication of guidance documents that provide new recommendations for developing good procedural practices for conducting studies using real-world data. Published in the September 2017 issue of Value in Health, this special collection of Task Force reports includes papers from both ISPOR and the International Society for Pharmacoepidemiology (ISPE) as part of the Joint ISPOR-ISPE Special Task Force on Real-World Evidence in Health Care Decision Making.
The ISPOR-ISPE Special Task Force was initiated to improve standards and practice for the collection and analysis of real-world data. The volume and diversity of real-world data have been growing exponentially as technology has made this information increasingly accessible. While clinical trial evidence remains the gold standard for the evaluation of treatment efficacy, there is increasing interest and potential for converting real-world data into real-world evidence that, through careful analysis and interpretation, can be used to inform health care decision making.
The special collection includes 2 full-length Task Force Reports, along with an accompanying editorial.
- Making Real-World Evidence More Useful for Decision Making offering editorial insight for the 2 reports, Sheldon Greenfield, MD, provides important background regarding the need to establish procedural practices that would enhance decision makers’ confidence in evidence derived from real-world data. After highlighting the Task Force recommendations, the editorial describes potential benefits of using hybrid data sources and offers examples of 2 recent types of studies that illustrate the notion of combining such complementary sources.
- Recommendations for Good Procedural Practices for Real-World Data Studies of Treatment Effectiveness and/or Comparative Effectiveness: Report of the Joint ISPOR-ISPE Special Task Force on Real-World Evidence in Health Care Decision Making is the report written by the ISPOR contingent of the Task Force. Lead author Marc Berger, MD, and colleagues offer 7 specific recommendations—each with an accompanying rationale—designed to enhance the confidence for including observational real-world data studies into the body of evidence decision makers consider for hypothesis-evaluating treatment effectiveness studies (i.e., studies with explicit a priori hypotheses).
- Reporting to Improve Reproducibility and Facilitate Validity Assessment for Health Care Database Studies, by Shirley Wang, PhD, et al, addresses transparency in the reporting of the implementation of real-world studies. Writing for the ISPE delegation of the Task Force, the authors suggest that, at a minimum, reporting for a database study should provide clarity regarding operational definitions for key temporal anchors and their relation to each other when creating the analytic dataset, accompanied by an attrition table and a design diagram.
The purposes of these two Task Force reports are complementary. They address several key aspects of transparency in overall study planning and procedural practices and transparent implementation of studies in order to facilitate study reproducibility. Along with available guidance documents on transparently reporting study results, these 2 reports aim to provide guidance that will ultimately lead to increased confidence in utilizing real-world evidence for decision making in health care.
ISPOR and ISPE are planning a stakeholder meeting, the ISPOR/ISPE Summit on Real-World Evidence in Health Care Decision Making, in Washington, DC, USA for October 20, 2017. The objective of the Summit is to begin a process of dissemination of these recommendations and to elicit input regarding what would be the best venue for study registration and what might be appropriate incentives for encouraging adherence to the recommendations. Additional information on the Summit can be found here and details on the ISPOR/ISPE Real-World Evidence Initiative can be found here.
The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a nonprofit, international, educational and scientific organization that promotes health economics and outcomes research excellence to improve decision making for health globally.
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ABOUT VALUE IN HEALTH
Value in Health (ISSN 1098-3015) is an international, indexed journal that publishes original research and health policy articles that advance the field of health economics and outcomes research to help health care leaders make evidence-based decisions. The journal’s 2016 impact factor score is 4.235. Value in Health is ranked 3rd out of 77 journals in health policy and services, 7th out of 347 journals in economics, and 9th out of 90 journals in health care sciences and services. Value in Health publishes 10 issues a year and circulates to more than 10,000 readers around the world. Web: www.ispor.org/valueinhealth_index.asp | Twitter: http://bit.ly/ISPORjournals-T (@ISPORjournals)
ABOUT ISPOR GOOD PRACTICES FOR OUTCOMES RESEARCH TASK FORCE REPORTS
ISPOR has earned an international reputation for research excellence based, in part, on its Good Practices for Outcomes Research Task Force Reports. These highly cited reports are expert consensus guideline recommendations on good practice standards for outcomes research (clinical, economic, and patient-reported outcomes) and on the use of this research in health care decision making. ISPOR Task Forces are comprised of subject matter experts representing different stakeholders from diverse work environments (i.e., regulators, payers, manufacturers, technology assessors, etc. from research, government, academic, and industry sectors around the world). All ISPOR Good Practices for Outcomes Research Task Force Reports are published in the Society’s scientific journal, Value in Health, and are made freely available as open access articles as part of the Society’s mission.
The International Society for Pharmacoepidemiology (ISPE) is an international organization dedicated to advancing the health of the public by providing a global forum for the open exchange of scientific information and for the development of policy, education, and advocacy for the field of pharmacoepidemiology, including such areas as pharmacovigilance, drug utilization research, comparative effectiveness research, and therapeutic risk management. Web: www.pharmacoepi.org