Clinical Trial Optimization

During the 2022 WCG MAGI Clinical Research Conferences in Boston and Las Vegas, Linda Sullivan invited attendees to stop by the CTO podcast booth and share their ideas about the top three things that the industry should do to improve how clinical trials are designed and executed. Don’t miss this rare opportunity to hear ideas from investigative site staff, clinical trial participants, and other industry stakeholders about opportunities to improve clinical research.

Hannah Reimer and Tara White at Temple University joined Linda Sullivan to discuss their collaboration to develop a systematic way of including researchers in the clinical care of patients. Faced with the challenge of not having patients eligible to enroll in clinical study due to low adherence to standard of care guidelines, the research team reached out to the clinical care team to explore how to address the problem. Working collaboratively with the quality improvement group, they were able to drive changes that resulted in improved adherence to standard of care guidelines which enabled the research team to achieve study enrollment goals. The new approach of including research staff in a quality improvement project was viewed positively and has opened the door for collaborations in the future.

Patricia Roselle, global head, patient stakeholder engagement at Sanofi ,joins  Linda Sullivan to share insights about the success of an innovative model that directly and intentionally collaborates with patient advisors and advocacy groups from around the world to co-design Sanofi’s end-to-end approach to medicines development.

Have you ever had a resume come across your desk that looked too good to be true? You bring the candidate in for an interview where they say all the perfect things, only to hire them and find out they were nothing like they led you to believe? This is the question explored during Linda Sullivan’s interview with Kylie Sands, Carly Lovelett, and McKailey Lyndaker at St Lawrence Health. The organization revamped their job interviewing process to better learn how a potential candidate could fit into their department and help everyone succeed. The new approach that assesses “soft skills”, as well as technical skills, is helping the organization identify job candidates that have the right critical thinking skills to be successful members of their clinical research team.

Brandi Bratrude at Boston Children’s Hospital and Mona Li at the Dana Farber Cancer Institute joined Linda Sullivan to discuss a successful Intern-to-FTE pipeline program at the Boston Children’s Hospital. The program, made possible through a collaboration with the Office of Workforce Development at the Dana-Farber Cancer Institute, works to ensure that youth and adults from underserved and underrepresented Boston neighborhoods have the access, skills, and resources necessary to pursue healthcare careers.

Is there a way for sponsors and clinical trial sites to donate unused lab kits and supplies for humanitarian aid? This is the question explored during Linda Sullivan’s interview with Mark Ryan vice president, head site management Americas region, and Donna Libretti-Cooke director of contracting and budgeting at Bayer and founder, Greg Folz and program coordinator, Josh Kravitz at Kits4Life. MedSurplus Alliance’s Kits4Life program was started to provide the means for unused clinical research supplies to be repurposed by organizations around the world that are qualified to accept humanitarian aid. Bayer has successfully implemented the program across clinical trial sites in the United States and is working with Kits4Life and other sponsors to expand the program globally. 

Additional information about Kits4Life is available at: https://www.medsurplusalliance.org/clinical-research-programs

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 [email protected].

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 [email protected].

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 [email protected]

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 [email protected]