Gerhard Fortwengel Livres

For academic medical faculty unfamiliar with national and international regulations, the prospect of initiating and managing a clinical trial can be intimidating. The development of protocols and case report forms, compliance with regulatory requirements, the monitoring of clinical trials as well as the responsibilities of documentation are just some of the tasks the sponsor-investigator is faced with. This book covers the entire spectrum of a clinical trial, reviewing the different stages step by step: financial planning, crucial aspects of trial design, the authorization process and, finally, documentation. Moreover, it contains helpful tips, a practical glossary, instructions and a large number of resources related to the relevant regulations and forms conforming to the ‘International Conference on Harmonization and Good Clinical Practice’. This makes the publication at hand an essential ‘cookbook’ for both academic faculty new to clinical trials as well as seasoned sponsors-investigators.

The standard to which clinical trials must conform is called 'Good Clinical Practice' (GCP). GCP is defined as a standard that ensures adequate protection of subjects participating in clinical trials; furthermore, it ensures that all trial activities and data are meticulously documented and reported. The latest GCP guideline was developed by the International Conference on Harmonization (ICH) and was first published in May 1996. This guideline is based on ethical principles that have their origin in the Declaration of Helsinki (1964, last modified in October 2000). Besides GCP, clinical trials must also comply with the local law of the country where the study is being conducted.This book will be an indispensable companion for those conducting clinical trials and should have a fixed place in the library of every investigator and his staff.

Eine Übersicht zur Entwicklung der Todesursachen und des Krankheitsgeschehens bei Kindern und Jugendlichen auf der Basis amtlicher Statistiken für den Zeitraum von 1960 bis 1991 existiert bisher nicht. Dabei stellen Kinder und Jugendliche eine Bevölkerungsgruppe dar, die vor dem Hintergrund gesundheitlicher Prävention und Intervention von allergrößter Bedeutung ist. Das Kindes- und Jugendalter ist die Entwicklungsphase, in der Gesundheits- und Krankheitsverhalten für das gesamte spätere Leben geprägt werden. Auch können in dieser Lebensphase schon körperliche Dispositionen oder Beeinträchtigungen angelegt werden, die zu einem späteren Zeitpunkt u. U. zu organischen Erkrankungen führen.