Comparative Effectiveness Research: A Pharmaceutical Industry Perspective on Outlook, Dilemmas, and Controversies
Comparative effectiveness research (CER) is the process of examining the performance of various medical treatments against each other. Many factors can affect how CER is performed and what conclusions are derived from any given study. Though the gold stan
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Comparative Effectiveness Research: A Pharmaceutical Industry Perspective on Outlook, Dilemmas, and Controversies Catherine Tak Piech, Patrick Lefebvre, and Crystal T. Pike
Abstract Comparative effectiveness research (CER) is the process of examining the performance of various medical treatments against each other. Many factors can affect how CER is performed and what conclusions are derived from any given study. Though the gold standard in health-care research remains the randomized controlled trial, CER studies that utilize real-world evidence can be valuable, as long as such studies are fit for purpose, have a rigorous methodology, and are easily interpretable and sources of bias have been minimized and disclosed. Though technological advances make it increasingly easier to perform sophisticated comparative analyses using ever-larger and increasingly detailed datasets, adoption and dissemination of CER by the US pharmaceutical industry has been surprisingly slow. This may be due to myriad of factors including regulatory and legal pitfalls, economic incentives, cultural influences, and public perceptions. Nevertheless, in an environment where both technological and economic pressures require smarter, less-resource intense ways of understanding the value and benefit of all existing treatments, CER has tremendous potential to improve decision making through its evidence-based approach to treatment choices. Alternative ways of conducting, interpreting, and disseminating CER should be a priority for the industry.
C.T. Piech (*) Janssen Scientific Affairs, LLC, A Subsidiary of Johnson & Johnson, Titusville, NJ, USA e-mail: [email protected] P. Lefebvre Analysis Group, Inc., Montreal, QC, Canada C.T. Pike Analysis Group, Inc., Boston, MA, USA © Springer Nature Singapore Pte Ltd. 2017 H.G. Birnbaum, P.E. Greenberg (eds.), Decision Making in a World of Comparative Effectiveness Research, DOI 10.1007/978-981-10-3262-2_5
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5.1 Introduction Knowing how the products or services we buy are compared in terms of characteristics, price, and performance is a fundamental step in making a purchasing choice in any market. It is expected that buyers will research a product or service in order to make comparisons among factors such as features, performance, price, terms, and availability before coming to a final decision, especially for an important or costly purchase. When a health issue arises and there is a need for treatment, it is a reasonable expectation that one would ask for and consider information about the comparative effects of the relevant treatment choices. The availability of comparative effectiveness research (CER) on treatment choices is a natural expectation that has strong, immediate, and universal appeal for its simplicity. However, experience working within the drug industry reveals insight into just how challenging this reasonable expectation is and the complexity of the issues that surround CER. By recognizing and understanding these obstacles, stakeholders (i.e., patients, clini
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