[Dealing with adverse effects in phase I trials].
A questionnaire was completed by members of the Association for Applied Human Pharmacology (AGAH) in Germany with the aim of assessing the present situation regarding management of adverse events (AEs). A recommendation for documentation and evaluation of AEs was to be presented after discussion within the AGAH. The questionnaire referred to general questions, documentation of AEs, intensity and causality, coding and serious adverse events (SAE). Percentage return of answered questionnaires was 54.5%. Of the people contacted, 9.1% said they did not carry out phase I trials, and 36.4% did not reply. The survey in the 24 institutes convers an estimated 11200 volunteers who are included in clinical trials each year. The discussion about commencement of AEs documentation and its duration was contentious. Of the respondents, 38.5% AEs only after application of the trial substance, while 61.5% also make a documentation during the pre-trial phase (recruitment, pre-examination, supervision before application). 13.6% document only up to the post-examination and half of those questioned until AE symptoms have disappeared. 22.7% document until disappearance of symptoms only when AEs are definitely associated with the trial substance. A 3-point scale is used by most people questioned for evaluation of the intensity of an AE. Evaluation of causality, mostly undertaken by the examining physician and the director of the clinical trial, is not carried out homogeneously. There are several categories, but four classifications are most commonly used. 62.5% of codings of AEs are carried out according to the WHO Adverse Reaction Terminology.(ABSTRACT TRUNCATED AT 250 WORDS)
Heger-Mahn
D
D
Institut für Humanpharmakologie, Schering AG, Berlin.
Mahler
M
M
Hermann
R
R
Nowak
H
H
Weber
W
W
Seibert-Grafe
M
M
D016907:Adverse Drug Reaction Reporting Systems; D017321:Clinical Trials, Phase I as Topic / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions; D005858:Germany; D006801:Humans; D012107:Research Design; D011795:Surveys and Questionnaires; D009626:Terminology as Topic
Umgang mit Unerwünschten Ereignissen in Phase-I-Prüfungen.