Estimands online workshop

Estimands online workshop

Staburo estimands online workshop

The gold standard for evaluating medical interventions is a randomised clinical trial with statistical analysis based on the intention-to-treat population. However, even if a randomised clinical trial is well planned, post-randomisation events occur and affect or even challenge the interpretation and validity of the study results.

In November 2019, ICH published an addendum to the ICH E9 guideline to address such problems by the so called “Estimand Framework”. This framework aims to ensure an alignment of trial objectives, study design, data collection, and choice of statistical analysis methods – at the stage of protocol writing.

The interactive workshop is designed for all stakeholders of a clinical study and will include many active training elements (50:50 ratio of theory vs. training)!! You will be trained on all topics of the estimand framework. We will present and discuss examples from various study phases and different medical indications. After this hands-on training you will be confident in developing and writing estimands for study protocols.

The course will be held in English and the detailed agenda will be sent out a few days before the start of the course. You find more details and how to register here!

Data analysis, clinical biostatistics and more.

Staburo @ CDISC 2021 Europe Interchange

Staburo @ CDISC 2021 Europe Interchange

Staburo @ CDISC 2021 Europe Interchange 

Data standards are of vital importance to transparent, high quality, efficient analysis and decision-making in all stages of clinical (and preclinical) research. Staburo was represented at the Clinical Data Interchange Standards Consortium (CDISC) 2021 Europe Interchange virtual conference, which took place from 28-30 April, to keep track of the latest developments in the field. Among the major themes of the conference were the integration of the data standards environment (e.g. CDISC, HL7 FHIR, OMOP Common Data Model), the implementation of the “biomedical concepts” approach in CDISC, and automated metadata processing and utilisation (e.g. via metadata repositories such as the CDISC Library). Besides the discussion of new technical developments, the presentations included case studies, showcasing of educational material and software tools, and regulatory perspectives. The challenges posed by the Covid19 pandemic were given special attention, including a presentation on the current status of vaccine development by the director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks.

Data analysis, clinical biostatistics and more.