Ugeskrift for laeger
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Ugeskrift for laeger · Apr 2003
[Intrathecal baclofen in the treatment of severe spastic tetraplegia and dystonia in children and adolescents].
Continuous intrathecal baclofen has been used over the past years especially in adult patients with spasticity of spinal origin. Children and young adults with severe spasticity and dystonia of cerebral origin are difficult to treat in spite of optimal systemic antispasmotic therapy with baclofen, tizanidine, dantrolene and/or diazepam. Intrathecal baclofen has therefore been applied in a group of young patients. ⋯ Continuous intrathecal baclofen was effective in treating severe spasticity and dystonia of cerebral origin with major effect on muscles of the lower extremities, pelvis, and back and in particular opisthotonus was relieved. Efficacy on upper extremities was far less pronounced.
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Ugeskrift for laeger · Apr 2003
Review[ICH-GCP Guideline: quality assurance of clinical trials. Status and perspectives].
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conduction, recording and reporting trials that involve the participating of human subjects. Since 1997 the ICH-GCP Guideline has been a requirement for conducting clinical trials which should be used as documentation to the authorities. ⋯ Investigator-initiated trials do not need to be conducted according to the GCP-principles but after the implementation of the EU Directive 2001/20/EC this will be changed. Today the GCP-principles only apply to clinical research with drugs but within a few years the GCP-principles will probably be a requirement for all clinical research.
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The contents and implications of the EU Directive on good clinical (research) practice (GCP) regarding drug trials are described. As of May 2003, clinical researchers in Denmark must have standard operation procedures, conduct monitoring, consider quality assurance, and expect inspections. The industry may be better prepared, but the Directive makes GCP part of the law and phase IV studies become subject to GCP. Patients will be assured the same quality in trials irrespective of the industry or investigator being the sponsor and may look forward to quality improvement of drug trials.
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Since 1992 a law based national system of Scientific Ethical Committees has existed. It consists of regional committees supplemented with a Central Committee. ⋯ A new law in 2003 will implement the EU directive on Good Clinical Practice. A maximum time of 60 days for the approval of biomedical research projects and approval of multi-centre trials at only one scientific ethical committee will be introduced.
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Ugeskrift for laeger · Apr 2003
Review[Contact and dialogue between drug companies and the global regulatory authorities throughout research and development phase].
Contact between pharmaceutical companies and local as well as global regulatory authorities (Ministry of Health) takes place throughout the development phase and especially when a clinical study is to be initiated. This contact is important both for the company and for the authorities, as both parties are constantly kept informed about the development progress and about the potential unexpected findings in connection with development of a new drug. The authority dialogue secures that authorities and companies exploit their resources optimally and patients get access to new, safe and efficacious drugs without delay.