Search: onr:"swepub:oai:DiVA.org:uu-504821" >
Causal inferences a...
Causal inferences and real-world evidence : A comparative effectiveness evaluation of abiraterone acetate against enzalutamide
-
- Johansson, Per (author)
- Uppsala universitet,Institutet för arbetsmarknads- och utbildningspolitisk utvärdering (IFAU),Statistiska institutionen,Hälsoekonomi,Tsinghua University, Beijing, China
-
- Jonéus, Paulina (author)
- Uppsala universitet,Statistiska institutionen
-
- Langenskiöld, Sophie, 1968- (author)
- Uppsala universitet,Hälsoekonomi
-
(creator_code:org_t)
- Public Library of Science (PLoS), 2023
- 2023
- English.
-
In: PLOS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 18:10
- Related links:
-
https://doi.org/10.1...
-
show more...
-
https://uu.diva-port... (primary) (Raw object)
-
https://urn.kb.se/re...
-
https://doi.org/10.1...
-
show less...
Abstract
Subject headings
Close
- Regulatory authorities are recognizing the need for real-world evidence (RWE) as a complement to randomized controlled trials in the approval of drugs. However, RWE needs to be fit for regulatory purposes. There is an ongoing discussion regarding whether pre-publication of a protocol on appropriate repositories, e.g. ClinicalTrials.gov, would increase the quality of RWE or not. This paper illustrates that an observational study based on a pre-published protocol can entail the same level of detail as a protocol for a randomized experiment. The strategy is exemplified by designing a comparative effectiveness evaluation of abiraterone acetate against enzalutamide in clinical practice. These two cancer drugs are prescribed to patients with advanced prostate cancer. Two complementary designs, including pre-analysis plans, were published before data on outcomes and proxy-outcomes were obtained. The underlying assumptions are assessed and both analyses show an increased mortality risk from being prescribed abiraterone acetate compared to enzalutamide.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Keyword
- epidemiology
- urological tumours
- public health
- prostate disease
Publication and Content Type
- ref (subject category)
- art (subject category)
Find in a library
-
PLOS ONE
(Search for host publication in LIBRIS)
To the university's database