Who is a 'healthy subject'?-consensus results on pivotal eligibility criteria for clinical trials.
Introduction/Methods : A discussion forum was hosted by the German not-for-profit Association for Applied Human Pharmacology (AGAH e.V.) to critically review key eligibility criteria and stopping rules for clinical trials with healthy subjects, enrolling stakeholders from the pharmaceutical industry...
| Publicado en: | European Journal of Clinical Pharmacology Vol. 73; no. 4; pp. 409 - 417 |
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| Autores principales: | , , , , , , , , , , , , , , |
| Formato: | review tables/charts Journal Article |
| Publicado: |
Springer Nature
Apr2017
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=121806666&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 121806666 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Apr2017 vid: 73 iid: 4 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 121806666 121806666 143935863 121806666 10.1007/s00228-016-2189-8 121806666 ppf: 409 ppct: 8 formats: fmt: @attributes: type: P tig: atl: Who is a 'healthy subject'?-consensus results on pivotal eligibility criteria for clinical trials. aug: au: Breithaupt-Groegler, Kerstin Coch, Christoph Coenen, Martin Donath, Frank Erb-Zohar, Katharina Francke, Klaus Goehler, Karin Iovino, Mario Kammerer, Klaus Mikus, Gerd Rengelshausen, Jens Sourgens, Hildegard Schinzel, Reinhard Sudhop, Thomas Wensing, Georg affil: -kbr- clinical pharmacology services , D-60431 Frankfurt am Main Germany sug: subj: Consensus Research Subject Recruitment Health Status Clinical Trials Eligibility Determination Congresses and Conferences Germany Alanine Aminotransferase Blood Aspartate Aminotransferase Blood Pulse Drugs, Investigational Pharmacy and Pharmacology Organizations Germany ab: Introduction/Methods : A discussion forum was hosted by the German not-for-profit Association for Applied Human Pharmacology (AGAH e.V.) to critically review key eligibility criteria and stopping rules for clinical trials with healthy subjects, enrolling stakeholders from the pharmaceutical industry, contract research organisations, academia, ethics committees and competent authority. Results : Pivotal eligibility criteria were defined for trials with new investigational medicinal products (IMPs) or with clinically established IMPs. In general, a pulse rate ranging between 50 and 90 beats/min is recommended for first-in-human (FIH) trials, while wider ranges seem acceptable for trials with clinically established IMPs, provided there are no indications of thyroid dysfunction. Hepatic laboratory parameters not to exceed the upper limit of normal (ULN) comprise ALT (alanine aminotransferase) and AST (aspartate aminotransferase) in FIH trials, whereas slight elevations (10% above ULN) seem acceptable in trials with clinically established IMPs without known hepatotoxicity. A normal renal function is required for any clinical trial in healthy subjects. A risk-adapted approach for stopping rules was adopted. Stopping rules for an individual subject are one adverse event of severe intensity or one serious adverse event. In case of a severe adverse event, some stakeholders demand a causal relationship with the IMP (i.e. an adverse reaction). Stopping rules for a cohort are one serious adverse reaction or ≥50% of subjects experiencing any adverse reaction of moderate or severe intensity. Consequences : The application of this consensus resulted in a reduction in protocol deficiencies issued by the competent authority. pubtype: Academic Journal doctype: review tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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