International journal of technology assessment in health care
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Int J Technol Assess Health Care · Jan 1998
Randomized Controlled Trial Multicenter Study Clinical TrialEconomic analysis of tirilazad mesylate for aneurysmal subarachnoid hemorrhage. Economic evaluation of a phase III clinical trial in Europe and Australia.
This study used data from a multinational phase III randomized, double-blind, vehicle-controlled trial to evaluate the cost-effectiveness of tirilazad mesylate (Freedox) in the treatment of aneurysmal subarachnoid hemorrhage. In men, therapy with 6 mg/kg per day of tirilazad mesylate was associated with significantly increased survival, increased cost of care, and ratios of cost per death averted that compare favorably with the ratios of other life and death interventions. In women, it appeared to have no effects on costs or survival. Further clinical studies may provide additional information about the cost-effectiveness of this intervention.
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Int J Technol Assess Health Care · Jan 2008
Value of information of a clinical prediction rule: informing the efficient use of healthcare and health research resources.
The aim of this study was to estimate the potential cost-effectiveness and expected value of perfect information of a recently derived clinical prediction rule for patients presenting to emergency departments with chest discomfort. ⋯ The EDPR is likely to be cost-effective; however, given the high degree of uncertainty in the estimates of costs and patient outcomes, further research is required to inform the decision to implement the intervention. The potential health and monetary benefits of this clinical prediction rule outweigh the costs of doing further research.
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When it is well conducted, a randomized clinical trial provides the strongest evidence available for evaluating the comparative effectiveness of the interventions tested. Over the last two generations, we have learned much about various devices for strengthening them and about methods of avoiding pitfalls in their design, execution, analysis, and reporting. ⋯ Because the controlled trial depends on an argument based on exclusion (i.e., no other causes or differences affected the experimental groups), we strengthen its inference by taking steps to exclude any such differences. This article discusses a number of issues that deserve consideration: problems and generalizability, devices for strengthening trials, issues of power and sample size, the relationship between study design and reported gains, when to undertake a trial, the role of collaborative trials, and ways to make trials more feasible in clinical settings.
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Int J Technol Assess Health Care · Apr 2011
ReviewHealth technology assessment in the era of personalized health care.
This article examines the challenges for health technology assessment (HTA) in the light of new developments of personalized health care, focusing on European HTA perspectives. ⋯ Integrative, systems biology-based approaches toward personalized medicine call for novel assessment methods. The translation of their highly innovative technologies into the practice of health care requires the development of new HTA concepts.
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Int J Technol Assess Health Care · Jan 2016
ENVIRONMENTAL SCAN ON PHARMACEUTICALS REQUIRING COMPANION DIAGNOSTICS.
Companion diagnostic tests (CDx) are used to measure an individual's protein or gene expression (biomarkers) to inform choice of therapy. The increasing number of drugs requiring CDx poses challenges for regulatory and reimbursement policies. To better understand this issue, an environmental scan was conducted by the Canadian Agency for Drugs and Technologies in Health (CADTH). ⋯ The market size for CDx is expected to considerably expand in the future. The drive in uptake may be influenced by many factors including an increased knowledge of biomarkers and molecular drivers of disease and the potential cost-savings associated with fewer treatment failures and adverse reactions. Assessing whether such benefits materialize is important. Health technology assessment will play an important role in informing policies regarding the clinical use and funding of pharmaceuticals with CDx.