Clinical Trial Optimization Linda Sullivan

How are organizations now tracking and assessing risk with risk-based quality management (RBQM) systems in the wake of new clinical trial designs and the COVDI-19 pandemic? That’s one of the key questions explored during Linda Sullivan’s interview with Duncan Hall, CEO and Founder at TRI — The Risk-Based Monitoring Company, which specializes in making RBQM simpler and more accessible. 
Duncan, who appeared on CTO Episode #4 (August 2020), discusses how RBQM has been transformed and become more utilized in the last two decades, how the pandemic accelerated further RBQM changes, and how accompanying key risk indicator metrics have evolved as well. Duncan notes that the pandemic forced clinical trial managers to accelerate plans to implement RBQM through centralized monitoring. He also discusses how the broader adoption of DCT modalities, including the increasing use of wearables, will impact the design and implementation of risk-based monitoring.  
Want to suggest a topic for CTO? Just email Linda Sullivan at lsullivan@wcgclinical.com.

How can organizations use advanced analytics to complement, enhance, and accelerate current QA practices? That’s one the key questions explored during Linda Sullivan’s interview with Timothé Ménard, Head Quality Data Science & Bioethics Coach in Product Development Quality at F. Hoffmann-La Roche. In his role at Roche, Ménard has been leading the product development Quality Data Science Team since January 2018.
From simple analytics methods to machine learning, Ménard’s team is creating and implementing data-driven solutions that help understand, early detect, and predict clinical and PV quality issues.
Sullivan notes that, in the last six years, many organizations have been implementing risk-based quality management approaches, based on evolving revisions to guidance such as ICH E6R2 and E8R1, which require specific data sets. According to Ménard, we should leverage and focus not just on clinical trial data but also on operational data, which is sometimes more challenging more than clinical data.
In regard to identifying and tracking quality issues, Ménard points out that analytics now can be applied on program and study levels, which expands critical analysis far beyond the site level and enables biopharmaceutical companies to accelerate the drug approval process. Ménard notes that his organization has been able to glean key insights from data that might not have been available a decade ago.
Want to suggest a topic for CTO? Just email Linda Sullivan at lsullivan@wcgclinical.com.

What’s the best way to develop world-class Quality Assurance (QA)  professionals in the clinical trials industry? That’s one of the key questions explored during Linda Sullivan’s interview with David Fryrear, Executive Vice President and Head of Quality Assurance at Astellas Pharma, Inc.
Clinical QA was first defined as “auditing,” says Fryrear, but it has morphed into a critical element in Quality Management Systems and is continuing to transform itself today. In addition, Fryrear notes, QA is now a resource for business partners and is a key contributor and independent voice in critical decision-making in the clinical trials process. Today, Fryrear says, top-notch QA professionals must demonstrate an ability to go beyond simply being well versed in regulatory and compliance issues, but must have different competencies, including an understanding of risk management, the ability to interpret data and apply critical thinking to solve problems as well as communicate effectively with peers and business partners.
Fryrear notes that Astellas has mapped out the core competencies needed and provides employees with opportunities to work closely with experienced staff to learn about and broaden their knowledge and expertise. “Quality is not the responsibility of QA – it is something that everyone needs to get involved in,” says Sullivan.
Want to suggest a topic for CTO? Just email Linda Sullivan at lsullivan@wcgclinical.com

In the final part of our three-part series on the value of Quality Tolerance Limits (QTLs), WCG Senior Advisor Linda Sullivan talks about methods for early detection of risk with Steve Young and Keith Dorricott. Young is the Chief Scientific Officer at CluePoints, who oversees the research and development of advanced methods for data analytics, data surveillance, and risk. Dorricott is a Master Black Belt who has spent more than 15 years applying process improvement techniques to address clinical research problems.
Young and Dorricott co-led a groundbreaking, WCG Metrics Champion Consortium QTL working group, which developed a guidance on QTL emerging best practices for Consortium members. In April 2022, a three-part series summarizing those discussions and recommendations was published on the Applied Clinical Trials Journal website: https://www.appliedclinicaltrialsonline.com/view/defining-quality-tolerance-limits-and-key-risk-indicators-that-detect-risks-in-a-timely-manner-reflections-from-early-adopters-on-emerging-best-practices-part-1
The three-part podcast series is designed to be a valuable podcast companion resource to the website article. In this episode, Young, Dorricott, and Sullivan discuss how to set the threshold and secondary tolerance limits to be proactive in dealing with risks, noting that it is sometimes difficult to determine. The group also talks about when to consider using leading indicator metrics as QTL parameters and/or companion KRI metrics to provide an earlier signal of that a risk will exceed the threshold before the end of the study. The first part of the series focused on the relationship between QTLs and KRIs. The second part of the series discussed the process of defining QTLs. If you subscribe to CTO, you will automatically receive those episodes. Want to suggest a topic for CTO? Just email Linda Sullivan at lsullivan@wcgclinical.com

In the second installment of our three-part series on defining and using Quality Tolerance Limits (QTLs), WCG Senior Advisor Linda Sullivan talks about the process of defining QTLs with Steve Young and Keith Dorricott. Young is the Chief Scientific Officer at CluePoints, who oversees the research and development of advanced methods for data analytics, data surveillance, and risk. Dorricott is a Master Black Belt who has spent more than 15 years applying process improvement techniques to address clinical research problems. Young and Dorricott co-led a groundbreaking, WCG Metrics Champion Consortium QTL working group, which developed a guidance on QTL emerging best practices for Consortium members.
In April 2022, a three-part series summarizing those discussions and recommendations was published on the Applied Clinical Trials Journal website: https://www.appliedclinicaltrialsonline.com/view/defining-quality-tolerance-limits-and-key-risk-indicators-that-detect-risks-in-a-timely-manner-reflections-from-early-adopters-on-emerging-best-practices-part-1
The three-part podcast series is designed to be a valuable podcast companion resource to the website article. In this episode, Young, Dorricott, and Sullivan discuss what factors go into the decision of whether to establish a QTL; the importance of key potential study failure points in developing QTLs; and how to determine the number of QTLs that should be implemented. The first part of this series discussed the relationship between QTLs and KRIs and the final installment of the series will focus on methods for early detection of risk. If you subscribe to CTO, you will automatically receive those episodes. Want to suggest a topic for CTO? Just email Linda Sullivan at lsullivan@wcgclinical.com

In the first of this three-part series on defining and using  Quality Tolerance Limits (QTLs), WCG Senior Advisor discusses the relationship between QTLs & KRIs  with Steve Young and Keith Dorricott. Young is the Chief Scientific Officer at CluePoints, who oversees the research and development of advanced data analytics, data surveillance, and risk methods.
Dorricott is a Master Black Belt who has spent more than 15 years applying process improvement techniques to address clinical research problems. Young and Dorricott co-led a groundbreaking, MCC QTL working group, which developed a guidance on QTL emerging best practices for Consortium members. In April 2022, a three-part series summarizing those discussions and recommendations was published on the Applied Clinical Trials Journal website here.
The three-part podcast series is designed to be a valuable podcast companion resource to the website article. In this episode, Young, Dorricott, and Sullivan discuss parameters and thresholds as they apply to QTL and KRIs, concluding QTLs should be considered as a designated subset of KRIs.
The group also discusses the working group’s mission; its process for determining best practices; the vendor perspective on QTLs; the importance of tracking risk; and the relationship of QTLs to centralized monitoring. The second part of the series will concentrate on defining QTLs and the final part of the series will focus on methods for early detection of risk. If you subscribe to CTO, you will automatically receive those episodes. Want to suggest a topic for CTO? Just email Linda Sullivan at lsullivan@wcgclinical.com