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conferenceseries.com
Volume 7, Issue 5 (Suppl) J Clin Trials, an open access journal
ISSN:2167-0870 Clinical Trials 2017
September 11-13, 2017
September 11-13, 2017 San Antonio, USA
4th International Conference on
Cl inical Tr ial s
Primary outcome is not significant, now what?
Geraldine E Baggs
Abbott Nutrition Research and Development, USA
Randomized controlled trials provide a high level of evidence regarding the cause and effect relationship between intervention
and a predefined primary outcome. Adequate well-controlled trials do not come with a low price tag. When the primary
outcome show small non-significant positive trends, what can be done to salvage the trial? While these neutral trials fall short
of providing convincing evidence of efficacy, sponsors are well served in mining the data for potential answers to the following:
Are there any subgroups that may potentially benefit from the intervention?, and are there any posthoc analyses that may help
elucidate the treatment effect? Posthoc analyses may help improve study design and in some cases establish care pathway.
Subgroup analyses are a useful hypotheses generating activity for future trials. Preferably, they have been prespecified in the
study protocol, based on the study primary outcome, found by tests for interactions and based on baseline risk categorization.
We present examples based on the sponsor experience and from the literature.
Biography
Geraldine E Baggs has completed her PhD in Statistics from The Ohio State University. She is currently working as a Section Manager of the Statistical Sciences
Department at Abbott Nutrition R&D. In this role, she provides statistical leadership in the design, monitoring, analysis, and interpretation of clinical trial data,
contributes to regulatory submissions and registration efforts globally, assists legal, QA and food safety groups, and manages the strategic direction of the statistical
sciences group.
Geraldine E Baggs, J Clin Trials 2017, 7:5 (Suppl)
DOI: 10.4172/2167-0870-C1-019