International journal of technology assessment in health care
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Int J Technol Assess Health Care · Dec 2014
Early dialogue with health technology assessment bodies: a European perspective.
Evidence requirements may differ across HTA bodies, and so pharmaceutical companies must plan to synergize their evidence generation strategy, across global regulatory and HTA bodies. Until recently, companies had no official platform to discuss the clinical development of a drug with HTA bodies; however, this is changing. ⋯ The availability of various options for early HTA consultation may help to avoid a mismatch between the evidence generated by means of a product's clinical development program, and the evidence expected by HTA bodies and payers, which can facilitate the pricing and reimbursement process upon a product's market authorization.
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Int J Technol Assess Health Care · Jan 2012
Incidence-based cost-of-illness model for metastatic breast cancer in the United States.
This study aims to estimate the annual U.S. societal costs associated with treatment of metastatic breast cancer (MBC) patients using an incidence-based cost-of-illness (COI) framework. ⋯ The societal burden of MBC in the United States is substantial. Earlier detection and effective treatment could lead to a significant decrease in costs while improving overall disease prognosis.
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Int J Technol Assess Health Care · Jul 2009
Comparative StudySurrogate outcomes in health technology assessment: an international comparison.
Our aim was to review the recommendations given by health technology assessment (HTA) institutions in their methodological guidelines concerning the use of surrogate outcomes in their assessments. In a second step, we aimed at quantifying the role surrogate parameters take in assessment reports. ⋯ HTA institutions seem to agree on a cautious approach to the use of surrogate outcomes in technology assessment. Thorough assessment of health technologies should not rely exclusively on surrogate outcomes.
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Int J Technol Assess Health Care · Jan 2010
Using clinical databases to evaluate healthcare interventions.
The aim of this study was to test the feasibility of conducting rigorous, nonrandomized studies (NRSs) of healthcare interventions using existing clinical databases in terms of the following: recruiting a large representative sample of hospitals, identifying eligible cases, matching cases to controls to achieve similar baseline characteristics, making meaningful comparisons of outcomes, and carrying out subgroup analyses. ⋯ Rigorous NRSs are feasible if they are based on data from high-quality clinical databases. However, the reliability of estimated treatment effects from such studies requires further investigation.