Current status of inclusion of older groups in evaluations of new medications: Gaps and implementation needs to fill them.
J Am Geriatr Soc
; 72(9): 2894-2902, 2024 Sep.
Article
em En
| MEDLINE
| ID: mdl-38600697
ABSTRACT
Under-representation of subgroups of the population in clinical trials has been and continues to be a problem despite goals of academia, industry, and government. Older adults are among the groups that are under-represented in trials of medications that they are likely to receive once marketing approval has been received. Recent legislation that mandates that clinical trial participants be representative of patient population has been passed and creates hope that greater numbers of older adults will be enrolled in clinical trials and that they will be representative of "typical" geriatric patients. However, there is the need for collection of current data on disease prevalences with granularity as to age, gender, and race as well as geriatric co-morbidities to assess the representativeness of clinical trial participants relative to patient populations. Consensus on definitions and collection of data relevant to geriatric patient populations are needed to evaluate effects of comorbidities, frailty, cognitive and physical function. There will also be a need for expansion of the geriatric research workforce, facilities for research both in academic centers but also in the community and long-term care facilities, and for engagement with and involvement of communities that have been traditionally under-represented to conduct clinical trials that enroll truly representative patient populations.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Ensaios Clínicos como Assunto
/
Seleção de Pacientes
Limite:
Aged
/
Aged80
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
J Am Geriatr Soc
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Estados Unidos