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Type I error probability spending for post-market drug and vaccine safety surveillance with binomial data.

ABSTRACT: Type I error probability spending functions are commonly used for designing sequential analysis of binomial data in clinical trials, but it is also quickly emerging for near-continuous sequential analysis of post-market drug and vaccine safety surveillance. It is well known that, for clinical trials, when the null hypothesis is not rejected, it is still important to minimize the sample size. Unlike in post-market drug and vaccine safety surveillance, that is not important. In post-market safety surveillance, specially when the surveillance involves identification of potential signals, the meaningful statistical performance measure to be minimized is the expected sample size when the null hypothesis is rejected. The present paper shows that, instead of the convex Type I error spending shape conventionally used in clinical trials, a concave shape is more indicated for post-market drug and vaccine safety surveillance. This is shown for both, continuous and group sequential analysis.

SUBMITTER: Silva IR

PROVIDER: S-EPMC6482950 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Type I error probability spending for post-market drug and vaccine safety surveillance with binomial data.

Silva Ivair R IR

Statistics in medicine 20170925 1

Type I error probability spending functions are commonly used for designing sequential analysis of binomial data in clinical trials, but it is also quickly emerging for near-continuous sequential analysis of post-market drug and vaccine safety surveillance. It is well known that, for clinical trials, when the null hypothesis is not rejected, it is still important to minimize the sample size. Unlike in post-market drug and vaccine safety surveillance, that is not important. In post-market safety ...[more]

PMID: 28948642

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Project description:Highlights • Active post-marketing safety surveillance on ROTASIIL, an oral rotavirus vaccine, was conducted in 9940 infants in India.• Three doses of ROTASIIL were administered at 6, 10 and 14 weeks of age, along with other EPI vaccines.• Most of the AEs were pyrexia and injection site reactions caused by the concomitant injectable vaccines.• No case of intussusception (IS) was reported.• ROTASIIL was safe and well tolerated. Background ROTASIIL, an oral live attenuated bovine-human reassortant pentavalent rotavirus vaccine, was approved in 2017. This post-marketing surveillance (PMS) was conducted to collect real-world data on the safety of ROTASIIL in India. Methods Observational, active PMS was conducted in approximately 10,000 infants aged ≥ 6 weeks. ROTASIIL was administered as a 3-dose regimen, at least 4 weeks apart, beginning at ≥ 6 weeks of age concomitantly with other Expanded Programme on Immunization (EPI) vaccines. Participants were followed for one month after the last dose. The adverse events (AEs) and serious adverse events (SAEs), including intussusception (IS) reported during the follow up period were collected. Findings A total of 9940 infants were enrolled and were considered for safety analysis. Around 9913 (99.7 %) infants received 2 doses, while 9893 (99.5 %) infants completed all three doses. Total 3693 AEs were reported in 2516 (25.3 %) participants. Most of these AEs were pyrexia (78.01 % of events) and injection-site reactions (19.14 % of events). Nearly all AEs were causally unrelated to orally administered ROTASIIL and could be caused by the concomitant injectable vaccines. Only 4 AEs (2 events of vomiting and 1 event each of discomfort and pyrexia) in 4 (<0.1 %) participants could be related to ROTASIIL. AEs were of mild or moderate severity and all resolved without any sequelae. A total of 2 SAEs (acute otitis media and skull fracture) were reported in 2 (<0.1 %) participants and were not related to ROTASIIL and recovered without sequelae. No case of IS was reported. Interpretation ROTASIIL was safe and well tolerated in this study. No safety concerns were reported. Funding The study was funded by SIIPL which is the manufacturer of the study product.

Dataset Information

Type I error probability spending for post-market drug and vaccine safety surveillance with binomial data.

Publications

Type I error probability spending for post-market drug and vaccine safety surveillance with binomial data.

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