WP06 - Outcome Analysis

Objectives

  • To further define end points, effect sizes, confirm power calculations.
  • To validate the trial design and procedures, particularly for randomization.
  • To develop the statistical analysis plan and perform final data analysis and produce statistical section of clinical study report.
  • To produce safety monitoring reports for DSMB.
  • To develop Bayesian statistical methodology in order to estimate disease modification effect of treatment eg by co morbidity and frailty.

Workpackage Description

The tasks of this workpackage relate to verification of the trial design, production of statistical reports relating to safety during the trial and performing the final analysis at trial completion.

Initially the protocol will be reviewed from a statistical point of view to ensure that end points are well defined and that the procedures being adopted meet stringent quality criteria. Particular attention will be given to procedures adopted for randomization and evaluation of the data forms for accurate recording of relevant parameters. Following this a Statistical Analysis Plan (SAP) will be developed specifying in great detail the proposed statistical analyses and how issues relating to missing data will be handled.

Along with the main analysis work will be carried out to identify and develop alternative analytic and statistical strategies to estimate disease modifying effects of the intervention. This will be undertaken in Trinity College Dublin

At fixed points during the trial blind reports will be produced for the Data Safety Monitoring Board (DSMB). On trial completion the final statistical analysis will be undertaken following the directions laid out in the SAP and the results section of the final report will be drafted. As part of this workpackage a secondary analysis of lifestyle factors will be undertaken by Stichting Katholieke Universiteit and of the biomarker sub-study by Goeteborgs Universitet.

WP Leader

University College Dublin (Prof. Leslie Daly)