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In 2014, a pilot project of the European licensing authority EMA was launched to explore new ways to license medicinal products. The intention of this project is to open up gradual (“adaptive”) licensing pathways, with pharmaceutical developing preparations gaining market authorization on the basis of clearly lower-level evidence of effectiveness and risk of damage than before. Their market authorization...
Most guidance developed by NICE is based on a value assessment using clearly articulated and published clinical and cost effectiveness criteria. In order to enable consistency and fairness across all decisions, NICE uses as a unit of health benefit the quality-adjusted life year (QALY). Both QALYs and costs for a technology are estimated by long-term disease modelling. This requires a variety of clinical...
In recent years, various options have been discussed to accelerate the approval of new drugs, especially for conditions with high unmet needs. There is a trade-off between the earlier availability of new treatment options and a potentially higher safety risk of drugs which have not been investigated in long-lasting clinical trials and a broader patient population. It must also be taken into account...
Following the adoption of the Cancer Screening and Registry Act (KFRG) to advance the development of the early detection of cancer and to promote quality assurance through Clinical Cancer Registries according to Sect. 65c SGB V, the question is raised as to what extent population-based clinical cancer registries may contribute not only to direct patient treatment benefits, but also to the requirements...
In some situations like a rare disease or an emergency intervention, a randomized controlled trial is rather difficult or even impossible to conduct. In these cases, the use of observational studies or registries for the assessment of effectiveness is discussed. Results from registries, however, are subject to the same methodological limitations as any non-randomized comparison. Specifically, the...
For the assessment of diagnostic and therapeutic interventions a sound scientific base has been developed during the last twenty years. Under the headline of Evidence-based Medicine nowadays a comprehensive set of tools is offered which can be used to assess the benefit and the risk of medical interventions. The overarching rule which evolved for the grading of evidence from studies is to maximize...
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