Risk-Based Monitoring and The IRB: Convergence and Opportunities

Current and emerging technologies allow the collection and analysis of larger data sets that can provide more valuable risk management insights than smaller data sets. The ability to monitor near real-time data and aggregate it with other data sources enables better risk governance and decision making which improves the safety and speed of clinical trials.

Effective risk governance comprises both risk assessment and risk management. Risk-Based Monitoring (RBM) is an example of real-time data collection and analytics supporting an important, structured approach to clinical trial risk management. Risk governance has long been within the purview of ERBs, whose primary review tasks include risk-benefit assessment and evaluation of risk management processes. RBM is a component of risk governance, and its structure is surprising similar to the systematic evaluations of ERBs.

Clinical operation teams and ERB oversight can benefit from this natural alignment to improve effectiveness of trial monitoring and oversight. Risk governance requires the collaboration and coordination of all concerned with the collection, analysis and communication of all relevant risk information, including the ERB. The opportunities for improvement introduced by RBM invite evaluation of a new pattern of interaction between clinical development teams and ERBs. The speakers will examine these opportunities and provide recommendations to industry, ERBs and other stakeholders.

Speakers

Andy Lawton, Global Head, Biometrics and Data Management, Boehringer Ingelheim Ltd.

Andy Lawton joined BI 28 years ago. Andy is responsible for managing the statistics, data management and programming groups with BIs UK operation. The group has specialised in the management of large scale trials and the implementation of risk based approaches within them. His experience covers over 33 years in clinical trials, but he also has extensive experience in the areas of computing, statistics, Data Management, RDE and system design. Andy was a founding Committee Member of ACDM and aided in the initiation of CDISC with the provision of the business model. Before joining BI, Andy worked as a statistician in the NHS and in computing in a geophysical exploration company.

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Ellen Kelso, Executive Director, Strategic Development, Chesapeake IRB

Ellen Kelso has more than thirty-five years of experience in the Pharmaceutical industry and currently serves Chesapeake IRB as Executive Director Strategic Development. Prior to Chesapeake IRB, Ms. Kelso founded Goodwyn IRB and served for 15 years as Managing Member and Chief Executive Officer. Ms. Kelso began her career with Eli Lilly and has served the Pharmaceutical industry in clinical operations and both domestic and international regulatory affairs. Her experience includes human subject protections; managing worldwide regulatory strategies; and establishing electronic content management, submission publication, and regulatory compliance processes. She has successfully combined the expertise of academic and industry professionals to create best practices and leverage technology to enhance ethical review and human subject protections.

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