Ethical Problems of Observational Studies and Big Data Compared to Randomized Trials.
J Med Philos
; 49(4): 389-398, 2024 Jul 11.
Article
em En
| MEDLINE
| ID: mdl-38739037
ABSTRACT
The temptation to use prospective observational studies (POS) instead of conducting difficult trials (RCTs) has always existed, but with the advent of powerful computers and large databases, it can become almost irresistible. We examine the potential consequences, were this to occur, by comparing two hypothetical studies of a new treatment one RCT, and one POS. The POS inevitably submits more patients to inferior research methodology. In RCTs, patients are clearly informed of the research context, and 11 randomized allocation between experimental and validated treatment balances risks for each patient. In POS, for each patient, the risks of receiving inferior treatment are impossible to estimate. The research context and the uncertainty are down-played, and patients and clinicians are at risk of becoming passive research subjects in studies performed from an outsider's view, which potentially has extraneous objectives, and is conducted without their explicit, autonomous, and voluntary involvement and consent.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Ensaios Clínicos Controlados Aleatórios como Assunto
/
Estudos Observacionais como Assunto
/
Big Data
Limite:
Humans
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article