The Use of Real-world Data to Assess the Impact of Safety-related Regulatory Interventions.
Sign Up to like & getrecommendations! Published in 2021 at "Clinical pharmacology and therapeutics"
DOI: 10.1002/cpt.2464
Abstract: The regulation of medicines seeks to ensure the efficacy, safety and quality of prescription and non-prescription medicines. Given that the conditions under which a medicine's benefits outweigh its risks are complex, it is essential that… read more here.
Keywords: real world; impact; safety; use real ... See more keywords
Modified use of real-time PCR detection of group B Streptococcus in pregnancy.
Sign Up to like & getrecommendations! Published in 2017 at "Journal of medical microbiology"
DOI: 10.1099/jmm.0.000604
Abstract: The CDC recommends antenatal screening of vaginal/rectal samples for Streptococcus agalactiae at 35-37 weeks' gestation, with intra-partum antibiotic prophylaxis for positive cases. We tested a modified use of the Cepheid Xpert GBS real-time PCR kit on… read more here.
Keywords: real time; time pcr; xpert gbs; use real ... See more keywords
Use of a real-world data approach to rapidly generate outcomes data following a case study of a novel treatment combination in pancreatic adenocarcinoma.
Sign Up to like & getrecommendations! Published in 2020 at "Journal of Clinical Oncology"
DOI: 10.1200/jco.2020.38.15_suppl.e16735
Abstract: e16735Background: We use a real-world data approach to report on safety and benefits on metastatic pancreatic cancer pts who were treated with a MEK inhibitor plus hydroxychloroquine (HCQ) after ex... read more here.
Keywords: real world; data approach; world data; use real ... See more keywords
A framework to guide the optimal development and use of real-world evidence for drug coverage and formulary decisions.
Sign Up to like & getrecommendations! Published in 2018 at "Journal of comparative effectiveness research"
DOI: 10.2217/cer-2018-0059
Abstract: AIM To provide a framework for optimizing the development and use of real-world evidence (RWE) in drug coverage decisions. Materials & methods: The Institute for Clinical and Economic Review convened a Policy Summit with representatives from… read more here.
Keywords: real world; world evidence; development use; coverage ... See more keywords