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French recommendations for clinical drug trials in cognitive disorders of the elderly
Author(s) -
Michel Bernard,
Sambuc Roland,
Scotto JeanClaude
Publication year - 1994
Publication title -
international journal of geriatric psychiatry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.28
H-Index - 129
eISSN - 1099-1166
pISSN - 0885-6230
DOI - 10.1002/gps.930091009
Subject(s) - clinical trial , drug trial , nosology , cognition , medicine , psychiatry , psychology , pathology
A consensus conference on the topic of clinical drug trials in cognitive disorders of the elderly was held in Marseille on January 28–29, 1993. At the end of this conference, several recommendations were made. Drugs used in trials must be chosen according to solid neurobiological evidence. Clinical trials profoundly alter the relations between the doctor, the patient and his family and this aspect must be taken into account. Clinical trials should be designed to obtain meaningful and useful data in the domains of pharmacology and epidemiology. Patient selection criteria must be defined with strict attention to the nosology of syndromes causing cognitive disorders in the elderly. Objective evaluation tests able to detect subtle drug effects must be carefully chosen according to the requirements of each trial. Whenever possible, laboratory tests should be used in addition to clinical data. The ethical implications of clinical trials in demented patients require special adaptation to satisfy legal requirements.