COVID19: Ensuring Scientific Integrity of Clinical Trials During the Pandemic

The global COVID-19 outbreak is affecting ongoing clinical trials to an extent that has never been previously witnessed. The ramifications of the pandemic will be long-lasting and far-reaching in the world of clinical trials. Studies will be affected in a variety of ways, such as slow patient recruitment, anticipated increase in missing data and a rise in protocol violations due to subjects being unable or unwilling to attend planned trial visits. The root cause of these problems is largely not under a sponsor’s control, and as the pandemic continues, actions must be put in place to quantify the impact of this outbreak and plan mitigation strategies to ensure the continuation of clinical trials in a safe, responsible and statistically sound manner.

This webinar will present potential scenarios that sponsors may face, such as re-assessment of the study size, the trial’s ability to deliver the promised results and the validity of the key study estimand and planned approaches for handling missing data. It will discuss related issues and examine potential solutions to maintain study integrity and preserve scientific validity and regulatory compliance.

Speakers

Niccolo Bassani, Principal Statistician I, Quanticate

Niccolo Bassani is a Principal Statistician at Quanticate and has worked on a large variety of projects spanning many TAs and Phase I to IV. He has provided input into study design and conducting, planning and executing statistical analysis and interacting with regulatory agencies. Prior to joining Quanticate in 2015, Bassani worked as a research fellow for nearly seven years in Medical Statistics at the University of Milan and for two years in the European Commission Joint Research Centre.

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Santosh Tymms, Statistician I, Quanticate

Santosh Tymms is a statistician at Quanticate. His role includes providing high-quality statistical support to clients, contributing to process improvement, knowledge sharing within the department and researching data quality oversight. Tymms has worked in medical statistics for four years following an MSc with Distinction from Lancaster University.

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Sonia Cobain, Principal Statistician I, Quanticate

Sonia Cobain is a principal statistician at Quanticate. Her role includes providing high-quality statistical support to clients, contributing to process improvement, knowledge sharing within the department and researching data quality oversight. Cobain has worked at Quanticate for 15 years following a MA in Biostatistics at Boston University.

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Sofia Baber, Senior Statistician II, Quanticate

Sofia Baber is a Senior Statistician at Quanticate and has five years of experience in the pharmaceutical industry. She did her BSc (Hons.) Mathematics (First Class) and MSc in Statistics (Distinction) from Imperial College London, UK before joining Quanticate in their UK head office, where she worked for about a year before moving to Canada, where she now lives. She has experience on a variety of indications across different phases and is involved with creating training for colleagues on various technical topics ranging from client and internal processes to implementation of stats analyses.

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Laura Cope, Senior Statistician I, Quanticate

Laura studied for an MSc in Statistics with Medical Applications at Sheffield University. After graduating in 2016, she began her career as a statistician at Quanticate. Over the last four years she has provided statistical support on a broad range of clinical trials, from early clinical development through to Phase IIIb/4 in numerous therapeutic areas.

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