FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W1968695738> ?p ?o ?g. }

• W1968695738 endingPage "1473" @default.
• W1968695738 startingPage "1473" @default.
• W1968695738 abstract "We write about the implications of increasing European legislation, aimed at protecting patients' rights, on the instigation of therapeutic clinical trials after brain trauma. European Parliamentary Directive 2001/20/EC1Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European Communities 1-5-2001, L 121/34-44.Google Scholar is expected to be enforced in all European countries by May, 2004. In an effort to increase protection of patients, this directive makes no provision for waiver of consent for those who are unable to express their wishes. Under the new legislation, informed consent can either be granted by the patient or, when incapacitated, by a legal representative, designated thus: “The notion of a legal representative refers back to existing national law and consequently may include natural or legal persons, an authority and/or a body provided by national law”.Our concerns relate primarily to situations in which acutely incapacitated patients need protection not only from illegal or disrespectful instigation of therapy but also from any deprivation of potentially effective treatment. Brain trauma is a universal cause of great morbidity and mortality in predominantly young adults throughout Europe, yet effective pharmacological treatment remains elusive. Preclinical studies inevitably indicate narrow therapeutic time windows, usually less than 6 h, after brain trauma during which sequences of destructive biochemical cascades can be manipulated to avert irreversible cerebral damage.2Faden AI Neuroprotection and traumatic brain injury: the search continues.Arch Neurol. 2001; 58: 1553-1555Crossref PubMed Scopus (54) Google Scholar Outcome after severe human brain trauma is affected by pronounced systemic hypoxia or hypotension that occurs shortly after injury, increasing unfavourable outcome three-fold,3Chesnut RM Marshall LF Klauber MR et al.The role of secondary brain injury in determining outcome from severe head injury.J Trauma. 1993; 34: 216-222Crossref PubMed Scopus (1650) Google Scholar yet effective interventional strategies to prevent such early insults have yet to be fully developed.We believe universal application of the directive as it stands will prevent effective therapeutic research during the acute phase after brain trauma. Without provision for waiver of consent, research into aspects of rescue, stabilisation at the accident scene, transport, and potential pharmacological treatments during early hours after trauma will be precluded. Results of a survey4Murray GD Teasdale GM Braakman R et al.The European Brain Injury Consortium survey of head injuries.Acta Neurochir. 1999; 141: 223-236Crossref PubMed Scopus (316) Google Scholar of head injury management in 67 European centres showed that 57% of patients were transferred from a primary-care hospital to a neurotrauma centre; median time from injury to specialist care was 4 h. Subsequent resuscitation, stabilisation, and investigations, including computed tomography scanning, add further hours.Despite obvious concerns about the ability to obtain valid informed assent from relatives in these circumstances, the requirement that informed consent be granted by a legal representative (who is rarely available during the relevant time frame) before any therapeutic intervention is undertaken enforces at best a minimum chance of efficacy. This directive also raises questions with respect to the ethical validity of offering therapeutic interventions outside of the optimum proven time windows to comply with European consent legislation.The European Brain Injury Consortium connects more than 100 neurotrauma centres throughout Europe by promoting scientifically valid and ethically sound clinical research into brain trauma. In writing this letter we acknowledge the need to fully protect patients' rights, but also wish to call for equally valid protection of the severely brain injured patient against a real threat of prevention of clinical research into potentially beneficial emergency interventions. Urgent debate is needed among political representatives, ethicists, medical experts, lay people, and patients and families who have endured brain trauma to devise balanced legislation to preserve, where appropriate, the ability to instigate clinical research into emergency care. In this respect we are most willing to contribute and offer expertise. We write about the implications of increasing European legislation, aimed at protecting patients' rights, on the instigation of therapeutic clinical trials after brain trauma. European Parliamentary Directive 2001/20/EC1Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European Communities 1-5-2001, L 121/34-44.Google Scholar is expected to be enforced in all European countries by May, 2004. In an effort to increase protection of patients, this directive makes no provision for waiver of consent for those who are unable to express their wishes. Under the new legislation, informed consent can either be granted by the patient or, when incapacitated, by a legal representative, designated thus: “The notion of a legal representative refers back to existing national law and consequently may include natural or legal persons, an authority and/or a body provided by national law”. Our concerns relate primarily to situations in which acutely incapacitated patients need protection not only from illegal or disrespectful instigation of therapy but also from any deprivation of potentially effective treatment. Brain trauma is a universal cause of great morbidity and mortality in predominantly young adults throughout Europe, yet effective pharmacological treatment remains elusive. Preclinical studies inevitably indicate narrow therapeutic time windows, usually less than 6 h, after brain trauma during which sequences of destructive biochemical cascades can be manipulated to avert irreversible cerebral damage.2Faden AI Neuroprotection and traumatic brain injury: the search continues.Arch Neurol. 2001; 58: 1553-1555Crossref PubMed Scopus (54) Google Scholar Outcome after severe human brain trauma is affected by pronounced systemic hypoxia or hypotension that occurs shortly after injury, increasing unfavourable outcome three-fold,3Chesnut RM Marshall LF Klauber MR et al.The role of secondary brain injury in determining outcome from severe head injury.J Trauma. 1993; 34: 216-222Crossref PubMed Scopus (1650) Google Scholar yet effective interventional strategies to prevent such early insults have yet to be fully developed. We believe universal application of the directive as it stands will prevent effective therapeutic research during the acute phase after brain trauma. Without provision for waiver of consent, research into aspects of rescue, stabilisation at the accident scene, transport, and potential pharmacological treatments during early hours after trauma will be precluded. Results of a survey4Murray GD Teasdale GM Braakman R et al.The European Brain Injury Consortium survey of head injuries.Acta Neurochir. 1999; 141: 223-236Crossref PubMed Scopus (316) Google Scholar of head injury management in 67 European centres showed that 57% of patients were transferred from a primary-care hospital to a neurotrauma centre; median time from injury to specialist care was 4 h. Subsequent resuscitation, stabilisation, and investigations, including computed tomography scanning, add further hours. Despite obvious concerns about the ability to obtain valid informed assent from relatives in these circumstances, the requirement that informed consent be granted by a legal representative (who is rarely available during the relevant time frame) before any therapeutic intervention is undertaken enforces at best a minimum chance of efficacy. This directive also raises questions with respect to the ethical validity of offering therapeutic interventions outside of the optimum proven time windows to comply with European consent legislation. The European Brain Injury Consortium connects more than 100 neurotrauma centres throughout Europe by promoting scientifically valid and ethically sound clinical research into brain trauma. In writing this letter we acknowledge the need to fully protect patients' rights, but also wish to call for equally valid protection of the severely brain injured patient against a real threat of prevention of clinical research into potentially beneficial emergency interventions. Urgent debate is needed among political representatives, ethicists, medical experts, lay people, and patients and families who have endured brain trauma to devise balanced legislation to preserve, where appropriate, the ability to instigate clinical research into emergency care. In this respect we are most willing to contribute and offer expertise." @default.
• W1968695738 created "2016-06-24" @default.
• W1968695738 creator A5012315167 @default.
• W1968695738 creator A5013952367 @default.
• W1968695738 creator A5014073957 @default.
• W1968695738 creator A5024063976 @default.
• W1968695738 creator A5031592480 @default.
• W1968695738 creator A5046564023 @default.
• W1968695738 creator A5047629461 @default.
• W1968695738 creator A5051285986 @default.
• W1968695738 creator A5060137338 @default.
• W1968695738 creator A5071073987 @default.
• W1968695738 creator A5076135151 @default.
• W1968695738 creator A5087562694 @default.
• W1968695738 creator A5088892217 @default.
• W1968695738 date "2003-04-01" @default.
• W1968695738 modified "2023-09-26" @default.
• W1968695738 title "New European Directive on clinical trials" @default.
• W1968695738 cites W1986301617 @default.
• W1968695738 cites W2057079435 @default.
• W1968695738 cites W2084962044 @default.
• W1968695738 doi "https://doi.org/10.1016/s0140-6736(03)13115-7" @default.
• W1968695738 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/12727418" @default.
• W1968695738 hasPublicationYear "2003" @default.
• W1968695738 type Work @default.
• W1968695738 sameAs 1968695738 @default.
• W1968695738 citedByCount "10" @default.
• W1968695738 countsByYear W19686957382012 @default.
• W1968695738 countsByYear W19686957382015 @default.
• W1968695738 crossrefType "journal-article" @default.
• W1968695738 hasAuthorship W1968695738A5012315167 @default.
• W1968695738 hasAuthorship W1968695738A5013952367 @default.
• W1968695738 hasAuthorship W1968695738A5014073957 @default.
• W1968695738 hasAuthorship W1968695738A5024063976 @default.
• W1968695738 hasAuthorship W1968695738A5031592480 @default.
• W1968695738 hasAuthorship W1968695738A5046564023 @default.
• W1968695738 hasAuthorship W1968695738A5047629461 @default.
• W1968695738 hasAuthorship W1968695738A5051285986 @default.
• W1968695738 hasAuthorship W1968695738A5060137338 @default.
• W1968695738 hasAuthorship W1968695738A5071073987 @default.
• W1968695738 hasAuthorship W1968695738A5076135151 @default.
• W1968695738 hasAuthorship W1968695738A5087562694 @default.
• W1968695738 hasAuthorship W1968695738A5088892217 @default.
• W1968695738 hasBestOaLocation W19686957381 @default.
• W1968695738 hasConcept C126322002 @default.
• W1968695738 hasConcept C17744445 @default.
• W1968695738 hasConcept C199360897 @default.
• W1968695738 hasConcept C199539241 @default.
• W1968695738 hasConcept C2779473830 @default.
• W1968695738 hasConcept C2779547435 @default.
• W1968695738 hasConcept C41008148 @default.
• W1968695738 hasConcept C535046627 @default.
• W1968695738 hasConcept C71924100 @default.
• W1968695738 hasConceptScore W1968695738C126322002 @default.
• W1968695738 hasConceptScore W1968695738C17744445 @default.
• W1968695738 hasConceptScore W1968695738C199360897 @default.
• W1968695738 hasConceptScore W1968695738C199539241 @default.
• W1968695738 hasConceptScore W1968695738C2779473830 @default.
• W1968695738 hasConceptScore W1968695738C2779547435 @default.
• W1968695738 hasConceptScore W1968695738C41008148 @default.
• W1968695738 hasConceptScore W1968695738C535046627 @default.
• W1968695738 hasConceptScore W1968695738C71924100 @default.
• W1968695738 hasIssue "9367" @default.
• W1968695738 hasLocation W19686957381 @default.
• W1968695738 hasLocation W19686957382 @default.
• W1968695738 hasOpenAccess W1968695738 @default.
• W1968695738 hasPrimaryLocation W19686957381 @default.
• W1968695738 hasRelatedWork W1595365545 @default.
• W1968695738 hasRelatedWork W2068857988 @default.
• W1968695738 hasRelatedWork W2100037320 @default.
• W1968695738 hasRelatedWork W2121563201 @default.
• W1968695738 hasRelatedWork W2154321601 @default.
• W1968695738 hasRelatedWork W2200810730 @default.
• W1968695738 hasRelatedWork W2415118569 @default.
• W1968695738 hasRelatedWork W2468516269 @default.
• W1968695738 hasRelatedWork W4214905129 @default.
• W1968695738 hasRelatedWork W1963894756 @default.
• W1968695738 hasVolume "361" @default.
• W1968695738 isParatext "false" @default.
• W1968695738 isRetracted "false" @default.
• W1968695738 magId "1968695738" @default.
• W1968695738 workType "article" @default.