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"Once again, we have a system that has failed to meet effectiveness and suitability requirements, but one that no doubt will proceed post-haste into full production and deployment," said Thomas P. Christie, a former top Pentagon testing official.
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There were a wide range of areas identified for improvement, but nearly half of the teams identified multidisciplinary team meeting effectiveness as a key issue.
Data shown are the number of treatment episodes in the off-diagonal cells given in Table 4. Column totals may sum to > 100% because there may be multiple reasons why patients did not meet the effectiveness gold standard or the effectiveness algorithm.
As a result orphan drugs are often expensive and rarely meet cost effectiveness criteria for public reimbursement, creating pressure on health officials to exempt orphan drugs from standard cost effectiveness thresholds.
And Roche is fighting several court cases to uphold its patent on the anticancer drug Tarceva, or erlotinib, that Indian drug makers argue does not meet the effectiveness standard.
In a report, published in 2012, the European Network on Debt and Development warned: "Do not implement new results-based approaches unless they respond to the demands of recipient country governments in consultation with civil society and parliaments, and have been designed to meet aid effectiveness principles.
Although it is true that not all orphan drugs are expensive, those that are inexpensive are likely to meet cost effectiveness thresholds, making the need for special funding status a moot point in those cases.
Wood and Wessely [ 15] list seven key aspects which peer review is expected to meet: efficiency, effectiveness, accountability, responsiveness, rationality, fairness and validity but suggest that realisation of any one of these objectives may mitigate the realisation of another.
However, preparticipation ECG screening has often been criticized for failing to meet cost-effectiveness thresholds, in part because of high false-positive rates and the cost of ECG screening itself.
Once the basic standards are met, the effectiveness of a mitigation measure is analyzed in more detail.
When conditions of psychological safety are not met, the effectiveness of PA might be questioned [ 14].
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com