A12 – Hot topics in clinical trials

During this session we will explore (1) The evolving role of the statistician in clinical research, focussing on some of the hot topics including risk-based monitoring and CDISC data standards. (2) Country selection and patient recruitment in biologics trials (biosimilar versus novel biologics, sharing data from a range of Phase 3 studies and exploring the motivational factors for patients and next generation patient recruitment strategies. (3) Operational intricacies of Phase 1 research, highlighting some of the challenges of phase 1 research and how it compares to the conduct of later phase research from a site operations perspective.

The role of the statistician in clinical research

The role of the statistician in clinical research is vast and broad, and is often misunderstood and under-utilised. This presentation aims to provide insight into the world of a clinical statistician in a clinical research organisation, in terms of day-to-day activities and cross-functional interactions including: study design, study protocol writing, eCRF and database design, risk assessments, regulatory input, data analysis, analysis reporting and clinical study report writing. In addition, this presentation will look at some of the challenges facing today’s clinical statisticians, and how their role is evolving, for example, risk-based monitoring and CDISC data standards. Lastly, this presentation will look at how statisticians can contribute to a clinical research organisation, beyond the standard expectations, to provide added-value to individual studies and programmes.

Chairperson: Elisa Young, Novotech