Work Package 4 - Plan for analyses

Pre-specified plan for analyses of primary and secondary clinical endpoints and integration of findings

Lead partner: Azienda Unita Sanitaria Locale Di Reggio Emilia (AUSL)

WP 4 activity is focused on the analysis of primary and secondary endpoints, and the integration of qualitative data analysis to guarantee a rigorous approach to data analysis and interpretation. Detailed description of specific issues related to data analyses, such as the choice of the population to be used in statistical analysis, the issue of missing data and the risk of bias, will add to the validity of the findings and their extrapolation to the target population.

As far as the BETTER-B Main Trial, the tasks of WP 4 are the following:

- to evaluate the qualitative data and how this should be integrated with the main trial;
- to develop and implement a rigorous analysis strategy
- to explore which patients characteristics are most associated with benefit from the intervention drug;
- to evaluate the results of the statistical analyses and contextualise them in terms of benefits to patients, persons close to them, clinical services, policy and the EU.

These tasks will be tackled by co-operation among the different expertise present in BETTER-B Consortium to reach a consensus agreement on research protocol, statistical analysis plan (SAP), statistical analyses, integration of all findings, and interpretation of the results.

WP 4 will lead continuous co-operation between WP2, WP3, WP5 and the Trial Management Group (TMG), the Trial Steering Committee (TSC), the statisticians in charge for the statistical analyses, and with all researchers directly involved in the design and conduct of the trial. Based on the results reported in the statistical report a clinical report will be prepared and agreed among all participants and shared with the BETTER-B Main Trial leaders.