No speaker found for J. Michael O’Bryan - M.D., MHA, MEDICAL AFFAIRS OFFICER (GREINER BIO-ONE NORTH AMERICA)
No speaker found for J. Michael O’Bryan - ()
- Experience-driven planning focused on operational and clinical risk identification
- Enabling faster, better insights that drive the next best actions
- Streamlining and automating processes with integrated monitoring solutions
To successfully implement RBQM, it is imperative to secure complete buy-in from leadership, business units and stakeholders to drive organizational change and cultivate a risk-based mindset in each study team. Properly educating colleagues in risk management is essential for improved outcomes.
- Address why a top down approach is key to changing mindsets
- Obtain strategies to identify key stakeholders and gain cross-functional buy-in
- Discuss effective methods to educate stakeholders on roles and responsibilities and the value of the initiative
- Hear effective strategies to change mindsets and culture from resistors to champions of RBQM
Despite all expectations and precautions, trials frequently fail. But what are the real reasons for this, and can any useful patterns be learned? This session will uncover reasons why studies fail and offer strategies for improving the likelihood of creating and executing a successful study.
- Shape your investigation into supporting data to determine causes
- Examine what can be done preemptively to mitigate risk and change the study outcome
- Hear why the focus should be on risk assessment and not KRIs
- Understand how to minimize the chance of a failed clinical trial
It is absolutely crucial that clinical teams are always ready for an inspection from the FDA or other regulatory bodies. Observations found by a health authority can always impact a clinical trial, regardless of where they take place and who is responsible for the site.
- Outline best practices for managing expectations and preparation strategies
- Gain perspective on how to prepare clinical teams for a clinical quality inspection
- Assess recent changes in inspector behavior and requirements
Regardless of where your organization may be in its RBQM journey, change is a constant, and proper change management is essential for implementing and scaling your program. You need to focus on the best tools and stakeholder engagement methods in order to build a successful change management culture.
- Examine the benefits of hiring a change management expert
- Recognize the value of structured programs to drive RBQM adoption
- Differentiate approaches for both enterprise-level risk and clinical trial project-level risk
- Share insights on how CROs should manage change to meet sponsors and auditors expectations
- Address lessons learned from change management initiative
Managing risks in clinical trials require a comprehensive approach covering all aspects across the organization (ie Regulatory, CMC, etc). You need to consider everything your organization looks for in risk – and if they haven’t, you help define it!
- Describe the guiding principles and key attributes of a clinical trial risk management framework
- Envision the timeframe for effectively implementing the framework
- Discuss Quality by Design and risk management
The ability to identify potential risks during clinical trial planning, analyze them, and develop an optimal risk mitigation strategy is essential for future clinical trial success. Most available industry tools and techniques focus primarily on risk assessment and risk-based monitoring. Detailed risk mitigation planning (which includes contingency budget allocation across multiple risks, determination of mitigation level for each risk, and deriving optimal risk mitigation strategy) is often overlooked. Deriving an effective clinical trial risk mitigation strategy could be time-consuming without proper modeling methodology. If a risk arises, necessary resources should be available on time to mitigate it.
- Discuss how to develop an optimal mitigation strategy
- Analyze how to allocate contingency budget across risks
- Address when to start risk mitigation
- Examine how to position the Secondary Limit for each risk before a trial starts
- Understand how to quantify clinical trial risk
ICH E8 emphasizes a Quality by Design (QbD) approach to trial design. However, implementing QbD can be a daunting task. This session provides a general overview of the principles and philosophy of QbD, and shares insight on what it means to different areas of clinical development and how to best incorporate it into your RBM program.
- Examine the three dimensions of QbD: quality, timelines, and cost)
- Compare different models of QbD implementation at the trialand company/organization levels
- Discuss benefits and best practices for multi-stakeholderengagement in the QbD process
- Understand how the pandemic has reinforced QbD principles
Today, clinical researchers are drowning in data. Yet, without data literacy, the numbers mean nothing— it is impossible to determine either the quality or the implications of the data. Data literacy can deduce insights, ask appropriate questions, and make clear data-based decisions.
- Identify the most valuable data and ascertain their true meaning
- Discuss what to do with the data
- Understand why data literacy is a key competency for risk-based quality management
- Examine data literacy as the change agent to deliver study wide insights
Artificial Intelligence and Machine Learning continue to be hot topics in clinical research as they have the potential to generate higher quality data, improve health outcomes through better decision making and more targeted innovation. However, there is still a lack of understanding on how to best leverage them in the RBQM process.
- Spotlight benefits of AI and ML for curating unstructured data
- Provide clarity on where in RBQM process ML can be leveraged most easily
- Insights on how to utilize AI and ML in the clinical research process
- Analyze how sponsors can use advanced machine learning to catch critical errors early and often
Most medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. Companies are responsible for filing new 510(k)s when a device change is important enough to affect the safety and effectiveness, or when a series of smaller changes eventually reach the "tipping point". How can diagnostic companies make that determination and what triggers such an analysis? By what means does a company examine what is required for a product change and for a process change? What are the different considerations for CE-marked products and how is this process riskbased? More importantly, how do device manufacturers maximize these processes against scarce resources?
- Review the U.S. FDA device clearance/approval
- Discuss the FDA's and EU's emphasis
- Examine product changes and filing a new 510(k)
- Insight on tracking and evaluating changes
- Determine the risk-based process
- Share insights on K-97-1 and the FDA's "Decision Tree"
- Discuss documenting the process/rationale
- Examine resolving a "wrong decision"
Decentralized or virtual trials are a trending concept brought into greater focus by the global health pandemic. With RBQM as the foundation required for decentralized and virtual clinical trials, the clinical research industry needs to ensure that new data oversight strategies required for decentralized clinical trials are in place to detect and prevent issues early in the process.
- Obtain an overview of challenges in implementing RBQM in virtual trials
- Evaluate risks involved in virtual trials
- Analyze challenges in monitoring risks with current RBQM practices
- Develop risk-based monitoring strategies which identifies critical to quality (CtQ) factors
- Learn how to adopt a monitoring strategy that best aligns with the risks of a particular study
The ICH E6 R2 addendum has highlighted the need for the pharma industry to re-examine how they approach clinical trial quality and vendor oversight activities to ensure the successful outcome of a clinical study.
- Examine challenges to vendor oversight— how to define it and how to manage it
- Explain how to perform a risk-based vendor assessment including how to pre-identify risks
- Identify different strategies to manage and mitigate risks
- Examine standardized way of benchmarking CRO and vendor performance
