We face an unprecedented challenge with the interest and mandate for data and result sharing, and the differing suggested solutions that are driven by stakeholders with different concerns and objectives. This series will discuss these challenges at all stages of the data lifecycle, from study inception to data archive/disposal, and demonstrate strategies to manage and document data integrity based on the ALCOA+ attributes and FAIR principles. The presenters will briefly describe the content of Data Management Plans (DT1), Data Monitoring Plans (DT1), Statistical Analysis Plans (DT2), and Trial Integrity Plans (DT3), in addition to ethical issues and potential conflicts and some initiatives that may resolve these problems.

Wednesday 7 September - Effective strategies to manage data integrity risks
Clinicians, consumers, journal editors and regulators alike expect reliable and accurate trial data, which requires meaningful and effective strategies to manage data integrity risks. In the presentation, Tracey Meares and Kylie Rogers will briefly describe the ALCOA+ attributes of data quality, common methods of managing data integrity risks across paper and electronic records and how to document these strategies in data management and data monitoring plans.

Presenters

Tracey Meares is the Trial Manager for the BEAT-CF platform trial in the Health & Clinical Analytics team, at the University of Sydney, Australia. She has over 20 years of experience as a trial manager in both industry (CRO, big pharma and small biotech) and academic clinical trials. Tracey spent the first 6 years of her career in clinical trials in Data Management, before moving into the Operational side of trials. Tracey specializes in the implementation and management of Bayesian adaptive clinical trials.

Kylie Rogers is the Data Management Lead in Adaptive Health Intelligence team, which is co-located between Telethon Kids Institute (TKI) and the University of Sydney, Australia. She has over 12 years of Clinical Data Management experience in both industry and academic clinical trials. Kylie specializes in database setup, data standards and automated data quality and consistency checks in complex clinical trials.

Wednesday 14 September - Transparency in data analyses

This session will focus on how to robustly and transparently plan, conduct and report statistical analyses. In this presentation, Laurent will explain how to develop a detailed pre-specified statistical analysis plan, adequately perform and validate analyses while remaining blinded to the data and transparently report the results.

Presenter

Laurent Billot is Director of the Biostatistics and Data Science Division at the George Institute for Global Health and Professor within the Faculty of Medicine at UNSW Sydney. He has over 20 years of experience in clinical research and is recognised internationally for his leading role in the design and analysis of large-scale randomised clinical trials in critical care, cardiovascular, neurological and musculoskeletal diseases. His research focuses on biostatistics and its application to the design and analysis of clinical trials.

Wednesday 28 September - The Data Lifecycle: Ethical use of data

The Data Lifecycle consists of “All phases of the process by which data are created, recorded, processed, reviewed, analysed and reported, transferred, stored and retrieved and monitored until retirement and disposal.” [… ]”commensurate with potential impact on patient safety, product quality and/or the reliability of the decisions made throughout all phases of the data life cycle” (WHO good data and record management practices - TRS 966 - Annex 5). In the presentation Ursula Garczarek will describe ethical issues and potential conflicts, and some initiatives that work on resolving the issues and conflicts.

Presenter

Ursula Garczarek, Ph.D. is Research Principal at Strategic Consulting in Cytel. As a member of Cytel’s Strategic Consulting team, Ursula provides guidance to trial sponsors on optimizing their development strategy, and successfully implementing trial design innovations. She applies new and pragmatic methodologies to address the needs and requirements of the sponsor within the regulatory environment. She is experienced with interactions with the FDA and the EMA for general drug development, medical devices and in rare diseases. Prior to Cytel, Ursula was the Program Leader Data Science at Unilever R&D (NL), and Biostatistician at Roche Diagnostics GmBH (DE) developing multi-marker diagnostics based on proteomics and metabonomics approaches. She received her Ph.D. from the University of Dortmund.

Audience

The series is designed for all trialists (clinicians, statisticians, data managers, trial managers, etc.) and members of human research ethics committees (HREC) and data safety and monitoring committees (DSMC). It is recommended that individuals should be familiar with the general concepts of Good Clinical Practice (GCP), as detailed in the ICH guidelines. Two (one hour) webinars are available on the ACTA STInG website that provide an overview of ICH for biostatisticians: https://clinicaltrialsalliance.org.au/resource/seven-steps-for-statistical-success-in-clinical-trials-good-clinical-practice-guidelines-part-1/ and https://clinicaltrialsalliance.org.au/resource/seven-steps-for-statistical-success-in-clinical-trials-good-clinical-practice-guidelines-part-2/