IDEAS home Printed from https://ideas.repec.org/a/bla/biomet/v71y2015i3p851-858.html
   My bibliography  Save this article

Continuous versus group sequential analysis for post‐market drug and vaccine safety surveillance

Author

Listed:
  • I. R. Silva
  • M. Kulldorff

Abstract

The use of sequential statistical analysis for post‐market drug safety surveillance is quickly emerging. Both continuous and group sequential analysis have been used, but consensus is lacking as to when to use which approach. We compare the statistical performance of continuous and group sequential analysis in terms of type I error probability; statistical power; expected time to signal when the null hypothesis is rejected; and the sample size required to end surveillance without rejecting the null. We present a mathematical proposition to show that for any group sequential design there always exists a continuous sequential design that is uniformly better. As a consequence, it is shown that more frequent testing is always better. Additionally, for a Poisson based probability model and a flat rejection boundary in terms of the log likelihood ratio, we compare the performance of various continuous and group sequential designs. Using exact calculations, we found that, for the parameter settings used, there is always a continuous design with shorter expected time to signal than the best group design. The two key conclusions from this article are (i) that any post‐market safety surveillance system should attempt to obtain data as frequently as possible, and (ii) that sequential testing should always be performed when new data arrives without deliberately waiting for additional data.

Suggested Citation

  • I. R. Silva & M. Kulldorff, 2015. "Continuous versus group sequential analysis for post‐market drug and vaccine safety surveillance," Biometrics, The International Biometric Society, vol. 71(3), pages 851-858, September.
  • Handle: RePEc:bla:biomet:v:71:y:2015:i:3:p:851-858
    DOI: 10.1111/biom.12324
    as

    Download full text from publisher

    File URL: https://doi.org/10.1111/biom.12324
    Download Restriction: no

    File URL: https://libkey.io/10.1111/biom.12324?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    Citations

    Citations are extracted by the CitEc Project, subscribe to its RSS feed for this item.
    as


    Cited by:

    1. Rex Shen & Keran Moll & Ying Lu & Lu Tian, 2023. "A seasonality‐adjusted sequential test for vaccine safety surveillance," Biometrics, The International Biometric Society, vol. 79(4), pages 3533-3548, December.
    2. Ivair R. Silva & Martin Kulldorff & W. Katherine Yih, 2020. "Optimal alpha spending for sequential analysis with binomial data," Journal of the Royal Statistical Society Series B, Royal Statistical Society, vol. 82(4), pages 1141-1164, September.
    3. Ivair R. Silva, 2018. "Type I Error Probability Spending for Post-Market Drug and Vaccine Safety Surveillance With Poisson Data," Methodology and Computing in Applied Probability, Springer, vol. 20(2), pages 739-750, June.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:bla:biomet:v:71:y:2015:i:3:p:851-858. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    We have no bibliographic references for this item. You can help adding them by using this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Wiley Content Delivery (email available below). General contact details of provider: http://www.blackwellpublishing.com/journal.asp?ref=0006-341X .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.