Ugeskrift for laeger
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Ugeskrift for laeger · Apr 2003
Randomized Controlled Trial Comparative Study Clinical Trial[Remifentanil and eye surgery. A randomized, clinical comparison of propofol/remifentanil anesthesia and propofol/fentanyl/alfentanil anesthesia].
The aim of this study was to investigate how many patients, after anesthesia with either propofol/remifentanil or propofol/fentanyl/alfentanil, within 20 minutes from the end of surgery could be transferred directly to the general ward. The number of undesired preoperative incidents, the anesthetists', the surgeons', and the patients' evaluations of the anesthesia were registered. An evaluation of the economic consequences of the two methods was also intended. ⋯ With a propofol/remifentanil-anesthesia, the patients had a predictably short awakening time, so they could be transferred directly to the general ward. This may, especially in ambulatory surgery, mean cost savings and perhaps higher patient satisfaction.
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According to a new EU Directive investigator initiated drug trials are to comply with the guidelines for Good Clinical Practice (GCP) as of May 2004. This implies that trials should be conducted according to a set of Standard Operating Procedures (SOPs) and be subject to monitoring and auditing. ⋯ In order to provide GCP services and guidance to the investigators it is proposed to establish 3-4 regional GCP units at the three university hospitals. The estimated annual cost for the 3-4 GCP units will be between DDK 7.5 and 10 million.
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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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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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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.