{"title":"Ethical Problems of Observational Studies and Big Data Compared to Randomized Trials.","authors":"Jean Raymond, Robert Fahed, Tim E Darsaut","doi":"10.1093/jmp/jhae021","DOIUrl":null,"url":null,"abstract":"<p><p>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 1:1 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.</p>","PeriodicalId":47377,"journal":{"name":"Journal of Medicine and Philosophy","volume":null,"pages":null},"PeriodicalIF":1.3000,"publicationDate":"2024-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Medicine and Philosophy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/jmp/jhae021","RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ETHICS","Score":null,"Total":0}
引用次数: 0
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 1:1 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.
期刊介绍:
This bimonthly publication explores the shared themes and concerns of philosophy and the medical sciences. Central issues in medical research and practice have important philosophical dimensions, for, in treating disease and promoting health, medicine involves presuppositions about human goals and values. Conversely, the concerns of philosophy often significantly relate to those of medicine, as philosophers seek to understand the nature of medical knowledge and the human condition in the modern world. In addition, recent developments in medical technology and treatment create moral problems that raise important philosophical questions. The Journal of Medicine and Philosophy aims to provide an ongoing forum for the discussion of such themes and issues.