Causal inferences and real-world evidence: A comparative effectiveness evaluation of abiraterone acetate against enzalutamide.

ABSTRACT: 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, i

SUBMITTER: Johansson P 

PROVIDER: S-EPMC10602359 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature