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Study-design in pandemics: from surveillance and performance-evaluation to licensing and pharmacovigilance

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cam.issuedOnline2022-07-12
dc.contributor.authorBird, Sheila
dc.contributor.orcidBird, Sheila M [0000-0001-6378-8382]
dc.date.accessioned2022-07-12T13:00:37Z
dc.date.available2022-07-12T13:00:37Z
dc.date.issued2022-07
dc.date.submitted2021-12-07
dc.date.updated2022-07-12T13:00:32Z
dc.description.abstractAndy Grieve, the first pharmaceutical statistician to be President of the Royal Statistical Society, practised in the regulated world of drug development. With reduction in drug development costs as his motivation, Grieve advanced Bayesian methods for developing predictive methods for efficacy and toxicity - to be used as early as possible in the drug development process; and his presidential address exhorted statisticians to weigh-in wherever data are used to make decisions. Diagnostic tests for infectious diseases are less regulated than drugs and vaccines unless the blood supply is at risk. Unlike in the HIV and HCV pandemics of the late 20th century, even well-designed surveys linked to a volunteered biological sample (to be tested for SARS-CoV-2 antigen or antibodies) have had modest or low consent rates. Record-linkage, statistical design and reporting standards have seen triumph and tragedy. Among the triumphs are: Liverpool’s insistence on dual testing (lateral flow device; polymerase chain reaction (PCR)) of some 6,000 asymptomatic citizens who attended for SARS-CoV-2-screening; two tricky randomized controlled public-policy trials on daily contact testing for close contacts of index cases of SARS-CoV-2 infection versus self-isolation (with or without initial PCR); and among already-consented participants in surveillance; over 80% secondary consent for linkage to their health records, including the Immunization Management Service. Before the next pandemic we need to entrench better regulation of diagnostic tests, better informed consent (not via weblinks), better feedback to participants, and transparency about basic safety data.
dc.description.sponsorshipThe study is led by PHE and funded by the Department of Health and Social Care (DHSC).
dc.identifier.doi10.17863/CAM.86437
dc.identifier.eissn1539-1612
dc.identifier.issn1539-1604
dc.identifier.otherpst2217
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/339029
dc.languageen
dc.language.isoeng
dc.publisherJohn Wiley and Sons
dc.publisher.urlhttp://dx.doi.org/10.1002/pst.2217
dc.subjectlicensing
dc.subjectpandemic
dc.subjectperformance-evaluation
dc.subjectpharmacovigilance
dc.subjectsurveillance
dc.subjectBayes Theorem
dc.subjectCOVID-19
dc.subjectHumans
dc.subjectPandemics
dc.subjectPharmacovigilance
dc.subjectSARS-CoV-2
dc.titleStudy-design in pandemics: from surveillance and performance-evaluation to licensing and pharmacovigilance
dc.typeArticle
dcterms.dateAccepted2022-04-29
prism.endingPage777
prism.issueIdentifier4
prism.publicationNamePharmaceutical Statistics: the journal of applied statistics in the pharmaceutical industry
prism.startingPage764
prism.volume21
rioxxterms.licenseref.urihttp://creativecommons.org/licenses/by/4.0/
rioxxterms.versionVoR
rioxxterms.versionofrecord10.1002/pst.2217

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