Predicting the accrual rate in a vaccine clinical trial: An a posteriori evaluation of the feasibility study

A. E. Tozzi, M. L. Ciofi Degli Atti, P. Panei, A. Anemona, N. Binkin, S. Salmaso, S. Luzi, D. Greco

Research output: Contribution to journalArticlepeer-review

Abstract

To estimate the expected accrual rate in a double blinded controlled randomized trial of the absolute clinical efficacy of three anti-pertussis vaccines in infants, we performed a series of surveys among mothers and physicians in the areas to be considered for participation in the trial. In this paper, we compared the predicted enrollment with the actual enrollment achieved at the end of the recruitment phase of the trial. The predicted enrollment rate was 27%, while the observed rate was 26%. Results from the feasibility study were highly predictive of actual enrollment rate. In the local health units (USL) where such assessments were carried out, the accrual rate was higher than those not participating in the feasibility phase.

Original languageEnglish
Pages (from-to)387-393
Number of pages7
JournalRevue d'Epidemiologie et de Sante Publique
Volume44
Issue number5
Publication statusPublished - Oct 1996

Keywords

  • clinical trials
  • KAP study
  • recruitment
  • vaccines

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health

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