title: [Clinical drug trials in elderly persons].
abstract: Older people belong to the social group who is the largest consumer of drugs. But despite this commonly known statement, the evidence base for the pharmacotherapy of older patients is small and insufficient. Elderly persons are often excluded from many clinical drug trials, which are used to determine the effectiveness and safety of drugs. The reasons to exclude the elderly patients from randomised controlled drug trials are: the age-related changes in different body functions, coexisting morbidities, drug complications connected with polypharmacotherapy, poor cognitive functions, inability to consent or even death. Mentioned reasons make more likely that included old frail patients will be unable to complete the trial. However in the context of growing old the population of many countries, it is imperative to find new ways in order to enhance participation of older people in clinical drug trials which allow to avoid dangerous risk of pharmacotherapy. The examples of recommended ways are: minimalization or avoidance of traditional exclusion criteria; inclusion larger sample sizes of the elderly into the population trials, the usage of short, simple, understandable and adaptable for this special group of persons, information and consent forms; using a measure, such as CGA-comprehensive geriatric assessment, for multidimensional evaluation of old patient status. Mentioned recommendations may enhance the objectivization of clinical research outcomes in the old age persons.
authors.affiliation: Akademia Medyczna we Wrocławiu, Katedra i Zakład Farmakologii Klinicznej. anwik@farmklin.am.wroc.pl
authors.forename: Krystyna
authors.initials: K
authors.lastname: Orzechowska-Juzwenko
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D002986:Clinical Trials as Topic; D004358:Drug Therapy / Q000706:statistics & numerical data*; D005260:Female; D016330:Frail Elderly; D015577:Geriatric Assessment; D006801:Humans; D008297:Male; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D012107:Research Design