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Benefit-risk methodology project:work package 1 report: description of the current practice of benefit-risk assessment for centralised procedure products in the EU regulatory network [PDF]
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Risk-Benefit Assessment of Anticoagulant Therapy
Drug Safety, 1991Thromboembolic disease is a common medical condition which, if untreated, carries a significant risk of morbidity and mortality. Treatment with anticoagulant therapy, while clearly beneficial, may expose patients to potentially serious side effects. A thoughtful risk-benefit assessment is therefore crucial before initiating therapy.
R, Harrington, J, Ansell
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The Risk-Benefit Assessment of Antidepressant Drugs
Medical Toxicology, 1987Antidepressant drugs in common use are reviewed in terms of their risks and benefits. A simple classification divides these into tricyclic antidepressants, monoamine oxidase inhibitors and second generation antidepressants. Risks may arise from the correct use of an antidepressant, from its incorrect or inappropriate use, or due to its failure to ...
J A, Henry, A J, Martin
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A Preliminary Risk-Benefit Assessment of Paclitaxel
Drug Safety, 1995Paclitaxel is an antineoplastic agent, first isolated and described in 1971. Despite its novel structure and apparent activity in vitro, little interest was shown in developing the compound because of its scarcity, problems with its formulation and the mistaken assumption that its mechanism of action was similar to that of the vinca alkaloids ...
R J, Bitton, W D, Figg, E, Reed
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Clinical equipoise and risk–benefit assessment
Clinical Trials, 2012Clinical equipoise is widely regarded as an ethical requirement for the design and conduct of randomized controlled trials (RCTs). Underlying clinical equipoise is the norm that no patient should be randomized to treatment known (or believed by the expert clinical community) to be inferior to the established standard of care. This implies that patient–
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A Risk-Benefit Assessment of Tamoxifen Therapy
Drug Safety, 1993Tamoxifen is the endocrine treatment of choice for all women with hormonally responsive breast cancer. 30 years of experience in both the laboratory and clinical setting have shown tamoxifen to be an effective adjuvant treatment with minor short term adverse effects. However, as therapeutic use has extended to 5 years and beyond, and as clinical trials
W H, Catherino, V C, Jordan
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Clinical risk–benefit assessment of dopamine agonists
European Journal of Neurology, 2008Dopamine agonists (DAs) have proven efficacy as monotherapy in early Parkinson’s disease (PD) for preventing motor complications such as dyskinesia and as adjunct therapy as the disease progresses. Further, it is increasingly evident that at least some DAs may provide additional benefits, such as reduction in depressive symptoms and treatment of ...
Möller, J. C. +6 more
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Risk-Benefit Assessment of Carbamazepine in Children
Drug Safety, 1991Carbamazepine is an effective antiepileptic drug for the treatment of partial and convulsive generalised epilepsy in adults and children. The pharmacokinetic profile in children is similar to that in adults, but the half-life in long term paediatric therapy is between 6 and 12 hours, compared with 15 hours in adults. Autoinduction is present.
M N, Seetharam, J M, Pellock
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Risk-Benefit Assessment of Tocolytic Drugs
Drug Safety, 1991beta 2-Mimetics are the principal agents used for myometrial relaxation. As all the available drugs also have beta 1-stimulant effects, the various side effects (cardiovascular, pulmonary and metabolic) require a critical consideration of the clinical indications, thorough supervision and combined therapeutic concepts.
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A Risk-Benefit Assessment of Amifostine in Cytoprotection
Drug Safety, 1999Recent advances in chemotherapy have focused on the benefit of high dose regimens, increasing the dose intensity of conventional chemotherapy and using intensified chemotherapy with or without autologous bone marrow rescue. Dose intensity usually increases objective response rates of antineoplastic drugs and might, in some circumstances, improves ...
M, Mabro, S, Faivre, E, Raymond
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