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Introducing Perspectives onComparative Effectiveness Research Howard G. Birnbaumand Paul E. GreenbergAnalysis Group, Inc., Boston, Massachusetts, USA

This issue of PharmacoEconomics is devotedentirely to issues related to comparative effec-tiveness research (CER). In recent years, therehas been a worldwide evolution in evidence-basedmedicine to focus on real-world comparative mea-surement. The most recent manifestation of thistrend is highlighted in the prominent role thatCER is playing in health reform in the US. Per-spectives on what CER is, how it should be im-plemented and what it will affect vary widely

across healthcare constituencies.As long-time observers and participants inmany health economics and outcomes researchdebates, we were struck by the wide-rangingperspectives and implications of this criticallyimportant and increasingly relevant conversa-tion. In response to these various perspectives, wesought to gather many of these voices and con-siderations together into a single volume.

This set of invited articles features perspectiveson CER from thought leaders representing key

vantage points: the pharmaceutical industry,pharmaceutical benefit managers (PBM), man-aged care pharmacy and various government andprivate payers (US, Canada and a cross-sectionof European and Pacific Rim countries), as wellas opinion leaders in the areas of health econ-omics and outcomes research. In some of thesearticles, the authors describe how their individualconstituencies regard potential conflicts and im-plementation issues related to CER, and howCER may evolve in the US healthcare system as itundergoes reform. As the co-editors of this spe-cial issue, we consciously sought perspectives onCER from diverse constituencies that are highly

opinionated and often conflicting. While wesought to include papers with a traditionalscientific orientation towards health outcomesresearch, in this compilation of perspectives wealso wanted to invite debate as well as to includesome white paper-style position statements, asappropriate. The rich diversity of papers in thisspecial issue includes attention to such issues asthe interaction of CER with personalized medi-cine and its granular focus on individual effect-

iveness and safety outcomes as opposed togroup-wide averages; the impacts of evolvingCER requirements on drug development; and awide range of methodological concerns, includ-ing several novel approaches to resolving com-plex analytical and data issues in connection withCER implementation. Our objective is to presenta broad balance of perspectives that readers canuse as a reference guide, albeit one that is differ-ent from the usual collection of applied papersfound in PharmacoEconomics .

The articles in the International Perspectivessection consider the evolution of comparativeeffectiveness-related research. Taken together,they suggest that, while there is receptivityworldwide to considering CER as part of thehealthcare policy decision-making process, sub-stantial barriers need resolution to incorporatereal-world evidence, particularly in the context of treatment costs. The Policy and Implementationsection adds further to this discussion by con-sidering alternative societal and private per-spectives about economic issues in prioritizinginvestments in CER, properly measuring costs,the impact on innovation, and the role of the

EDITORIAL Pharmacoeconomics 2010; 28 (10): 787-7881170-7690/10/0010-0787/$49.95/0 2010 Adis Data Information BV. All rights reserved.

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clinician in applying the knowledge gained fromCER. Not surprisingly, the Industry Perspectivessection includes articles that grapple with thepractical implications of CER and whether theseforces are catalyzing or colliding in the contextof drug innovation and development, reimburse-ment, and implications for patient care. Finally,the Methodological Considerations section presentssome innovative suggestions to address several of the classic problems confronting researchers seek-ing to compare treatment outcomes in the contextof limited real-world data.

In summary, the contributors to this specialissue discuss a host of matters raised by CERconsiderations. There is movement to considerinterventions that, while they have not typicallybeen subjected to real-world observation, dohave the potential to lead to improved outcomes

for at least some of the constituencies involved.As is made clear in these articles, stakeholdersoffer a divergent range of views on CER.

It remains to be seen whether CER will be acatalyst for conflict or a driver of positive change.How will resulting outcomes evidence be used,and what will be its policy impacts? How willvarious methodological issues get resolved? Willopposing points of view move toward a commonground, and in what areas is this most likely tooccur? These are among the key topics that aretaken up in this special issue.

Howard G. BirnbaumPaul E. Greenberg

Guest EditorsSpecial Issue on Comparative

Effectiveness Research

788 Birnbaum & Greenberg

2010 Adis Data Information BV. All rights reserved. Pharmacoeconomics 2010; 28 (10)