title: Early economic evaluation of emerging health technologies: protocol of a systematic review.
abstract: BACKGROUND
  The concept of early health technology assessment, discussed well over a decade, has now been collaboratively implemented by industry, government, and academia to select and expedite the development of emerging technologies that may address the needs of patients and health systems. Early economic evaluation is essential to assess the value of emerging technologies, but empirical data to inform the current practice of early evaluation is limited. We propose a systematic review of early economic evaluation studies in order to better understand the current practice.
  
  
  METHODS
  This protocol describes a systematic review of economic evaluation studies of regulated health technologies in which the evaluation is conducted prior to regulatory approval and when the technology effectiveness is not well established. Included studies must report an economic evaluation, defined as the comparative analysis of alternatives with respect to their associated costs and health consequences, and must evaluate some regulated health technology such as pharmaceuticals, biologics, high-risk medical devices, or biomarkers. We will conduct the literature search on multiple databases, including MEDLINE, EMBASE, the Centre for Reviews and Dissemination Databases, and EconLit. Additional citations will be identified via scanning reference lists and author searching. We suspect that many early economic evaluation studies are unpublished, especially those conducted for internal use only. Additionally, we use a chain-referral sampling approach to identify authors of unpublished studies who work in technology discovery and development, starting out with our contact lists and authors who published relevant studies. Citation screening and full-text review will be conducted by pairs of reviewers. Abstracted data will include those related to the decision context and decision problem of the early evaluation, evaluation methods (e.g., data sources, methods, and assumptions used to identify, measure, and value the likely effectiveness and the costs and consequences of the new technology, handling of uncertainty), and whether the study results adequately address the main study question or objective. Data will be summarized overall and stratified by publication status.
  
  
  CONCLUSIONS
  This study is timely to inform early economic evaluation practice, given the international trend in early health technology assessment initiatives.
authors: Toronto Health Economics and Technology Assessment Collaborative, University of Toronto, Leslie Dan Pharmacy Building, 6th floor, Room 651, 144 College Street, Toronto, Ontario M5S 3M2, Canada. ba.pham@theta.utoronto.ca.
authors: Ba'
authors: B
authors: Pham
authors: Hong Anh Thi
authors: HA
authors: Tu
authors: Dolly
authors: D
authors: Han
authors: Petros
authors: P
authors: Pechlivanoglou
authors: Fiona
authors: F
authors: Miller
authors: Valeria
authors: V
authors: Rac
authors: Warren
authors: W
authors: Chin
authors: Andrea C
authors: AC
authors: Tricco
authors: Mike
authors: M
authors: Paulden
authors: Joanna
authors: J
authors: Bielecki
authors: Murray
authors: M
authors: Krahn
mesh_terms: D020811:Biomedical Technology / Q000191:economics*; D003362:Cost-Benefit Analysis; D016247:Information Storage and Retrieval / Q000379:methods*; D012196:Review Literature as Topic; D000078202:Systematic Reviews as Topic