Forschung ohne Tierversuche 1996 pp 159-177 | Cite as
ECVAM Task Force Biostatistics: Stand und Perspektiven der Anwendung biometrischer Methoden bei der Validierung von Ersatz- und Ergänzungsmethoden
Zusammenfassung
Zusammenfassung
Im Oktober 1994 wurde von ECVAM (European Centre for the Validation of Alternative Methods) die Task Force „Biostatistics“ (TFB) ins Leben gerufen. Der Autor dieses Beitrages wurde als Vorsitzender dieser Task Force nominiert. Primäres Anliegen der TFB ist die Sicherung eines hohen Qualitätsstandards biometrischer Untersuchungen bei der Entwicklung und Validierung von toxikologischen Alternativmethoden. Dafür wurden von der TFB Richtlinien und Empfehlungen entworfen (ECVAM Biostatistics Task Force Report 1), die demnächst in der Zeitschtift ATLA veröffentlicht werden. Diese Empfehlungen werden sicherlich eine kontroverse Diskussion zwischen Toxikologen, Biometrikern und öffentlichen Entscheidungsträgern auslösen, da bisherige nationale und internationale Validierungsstudien zeigen, daß über Art und Umfang der einzusetzenden biostatistischen Methoden sowie den grundsätzlichen Stellenwert biostatistischer Ergebnisse bei der endgültigen Entscheidung über eine Alternativmethode erhebliche Meinungsverschiedenheiten existieren. Dieser Artikel gibt in gekürzter Form die Empfehlungen der TFB wider.
Summary
ECVAM Task Force Biostatistics: State of the art and perspectives of the application od biometric methods at the validation of alternatives to animal testing
In October 1994, the Task Force “Biostatistics” (TFB) was founded by ECVAM (European Centre for the Validation of Alternative Methods). The author of this manuscript was nominated chairman of this Tska Force. The primary aim of the Task Force is to guarantee high quality standards of biometric examinations during the development and the validation of toxicological alternatives. With regard to this, the TFB drafted guidelines and recommendations (ECVAM Biostatistics Task Force Report 1) which will be published soon in ATLA. The recommendations will surely lead ot controversial discussions among experts in toxicology, biometrics and public decision-taking people, because up to now national and international validation studies showed that extremly different opinions exist about the way and extend of biostatistical methods to be used and also about the basic value of biostatistical data for the decision about alternative methods. This manuscript resumes in short the recommendations of the TFB.
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