PMID- 7741796
OWN - NLM
STAT- MEDLINE
DCOM- 19950607
LR  - 20151119
IS  - 0004-4172 (Print)
IS  - 0004-4172 (Linking)
VI  - 45
IP  - 3
DP  - 1995 Mar
TI  - [Dealing with adverse effects in phase I trials].
PG  - 331-6
AB  - 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)
FAU - Heger-Mahn, D
AU  - Heger-Mahn D
AD  - Institut fur Humanpharmakologie, Schering AG, Berlin.
FAU - Mahler, M
AU  - Mahler M
FAU - Hermann, R
AU  - Hermann R
FAU - Nowak, H
AU  - Nowak H
FAU - Weber, W
AU  - Weber W
FAU - Seibert-Grafe, M
AU  - Seibert-Grafe M
LA  - ger
PT  - English Abstract
PT  - Journal Article
TT  - Umgang mit Unerwunschten Ereignissen in Phase-I-Prufungen.
PL  - Germany
TA  - Arzneimittelforschung
JT  - Arzneimittel-Forschung
JID - 0372660
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - Clinical Trials, Phase I as Topic/*methods
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Germany
MH  - Humans
MH  - Research Design
MH  - Surveys and Questionnaires
MH  - Terminology as Topic
EDAT- 1995/03/01 00:00
MHDA- 1995/03/01 00:01
CRDT- 1995/03/01 00:00
PHST- 1995/03/01 00:00 [pubmed]
PHST- 1995/03/01 00:01 [medline]
PHST- 1995/03/01 00:00 [entrez]
PST - ppublish
SO  - Arzneimittelforschung. 1995 Mar;45(3):331-6.