Episodes
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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.
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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.
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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.
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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.
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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.
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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
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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].
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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].
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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]
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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]
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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 [email protected]
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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 [email protected]
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What’s the current status of diversity efforts in clinical trials given the recent FDA draft guidance and the introduction of the Diverse and Equitable Participation in Clinical Trials (DEPICT) in Congress? That’s the main topic explored during WCG Senior Advisor’s interview with Lori Abrams, Vice President, Patient Advocacy & Clinical Research Diversity, at WCG. Abrams has a long history of improving clinical drug development by including patients, caregivers, and advocacy groups into every aspect of the development continuum. In her last corporate role, Lori was Director of Diversity & Patient Engagement at Bristol-Myers Squibb (BMS) where she built one of the first clinical trial advocacy groups in R&D in pharma.
Sullivan and Abrams discuss the most important diversity and patient voice developments in clinical trials, including General Considerations for Clinical Studies/Guidance for Industry, adopted by ICH in October 2021; FDA’s guidance on Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry released in Nov 2020; FDA’s draft guidance on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry released on April 13, 2022, and the DEPICT Act, which was introduced in the United States Congress on February 9, 2022. The legislation aims to boost diversity in clinical trials by requiring enhanced data reporting on clinical trial demographics and providing resources to improve access to clinical trials. Abrams also talks about how these changes have increased the urgency that sponsors now feel to implement patient diversity programs.
Want to suggest a topic for CTO? Just email Linda Sullivan at [email protected]
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What are the most important lessons learned by clinical research sites from having to deal with the COVID-19 pandemic the last two years, and what are the challenges these sites face going forward?. That’s the key topic explored during Senior Advisor Linda Sullivan’s interview with Sandys Smith, Senior Vice President, Clinical Solutions and Strategic Partnerships for WCG. Smith, who has spent her career partnering with physicians and other healthcare stakeholders to drive customer value and clinical excellence in patient-centric oncology services, discusses how the lockdown affected clinical research site operations, and what enabled certain sites to pivot more easily. Smith discusses how telehealth and remote monitoring took off, hospitals functioned with insufficient staff, and the Great Resignation occurred. What that meant, she says, was that fewer personnel and resources were available to health care organizations and clinical sites. Smith also talks about where clinical sites are today in terms of trial backlogs, a recent uptick in new starts in March, still existing staffing shortages and the need for additional training for less experienced investigators, and how sites can be better supported. Finally, Smith talks about the advantages of adopting a hybrid, decentralized clinical trial model — a combination of onsite and virtual participant visits — that enables sites to enroll patients who don’t live near clinical sites. Clinical sites are looking at how to get the work done most effectively, such as partnering with outside organizations to do budgets and/or utilizing remote staffers and deploying technology-based research solutions, according to Smith.
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What’s the current status of the WCG Avoca Quality Consortium (AQC) — the exciting new collaboration between Metrics Champion Consortium (MCC) and Avoca Quality Consortium, whose mission is to elevate clinical trial quality, drive efficiency, and mitigate risk through industry collaboration by providing a more holistic approach to improving clinical trial operations. That’s the key topic explored during Senior Advisor Linda Sullivan’s interview with Michelle Webb, Vice President of WCG’s AQC. The consortium is a diverse, global organization of more than 180 members that includes pharmaceutical and biotech companies, sites, and clinical service providers, who come together to achieve alignment within the industry, according to Webb. The integration of MCC with the AQC has enabled members to access information in one resource and proves that “the whole is greater than the sum of its parts,” she adds. True integration, Webb explains, has begun as members are participating in both Communities of Practice, which was traditionally MCC-based, and in Leadership Advisory Boards, which were historically AQC-based. The main 2022 workstreams for the consortium, she notes, including innovation adoption, inspection readiness, provider qualification, risk-based quality management, site quality, safety and metrics development workgroups, all intertwine with the overall themes of expansion and inclusion. Webb and Sullivan also discuss the importance of brainstorming in consortium meetings representing a unique approach to engaging members. Finally, Webb points out how the consortium will be keeping members current on regulatory updates and new guidance documents.
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What are best strategies for utilizing the promise of machine learning, deep learning, and artificial intelligence (AI) in clinical trials? That’s the key topic explored during MCC’s Linda Sullivan’s interview with Jonathan Rowe, Principal at ZS, where he leads the R&D, quality, and operations risk management function, and former head of clinical development, quality performance, and risk management at Pfizer. In general, Rowe notes, AI systems today are becoming increasingly useful in the industry and are providing encouraging results in developing higher quality, lower risk, protocols based upon learning from the performance of previous trials. AI is currently being developed to be able to review multiple forms of text-based clinical trial information such as audit reports, protocol deviations and monitoring visit reports. Using AI in this regard allows for the identification of issues and risks across a portfolio. Eventually AI might prove effective in people helping capture better text-based information across the trial enterprise. Well-trained AI may ultimately help determine whether particular study events were truly significant or not as well as producing improvements in report writing and enhancing risk management. It’s important to train AI systems to be more sensitive to particular text writing in reports, and we shouldn’t lose that capability, asserts Rowe. “We’re getting pretty good in categorizing findings,” Rowe says. “But we’re not at 100 percent accuracy”, he adds. Sullivan and Rowe also discuss the pros and cons of using AI to assist in looking for trends in CAPA issues and root cause data.
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How will the collaboration between Metrics Champion Consortium (MCC) and Avoca Quality Consortium (AQC) help develop new deliverables for the clinical trials industry? That’s the key topic explored during MCC’s Linda Sullivan’s special interview with Patty Leuchten, Founder and CEO of WCG Avoca. In September 2021, WCG announced exciting news: AQC and MCC were joining forces in 2022 to form a single industry consortium. AQC and MCC are similar in having SMEs facilitate the research and development of consortium deliverables with the input of consortium members rather than having member companies do the “heavy lifting.” Leuchten and Sullivan discuss how their two organizations will be working together to integrate the extensive AQC knowledge center assets and MCC metric sets and tools. This collaboration will enable the single consortium to produce new resources for the industry to utilize in several clinical trials areas. Leuchten talks about her experience with clinical trials during the COVID pandemic, noting how it spurred innovation with new technology without incurring “undue risk.” In conclusion, Sullivan and Leuchten agree that the new consortium platform will provide an exciting resource and added value for members to explore and drive innovation in conducting clinical trials.
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What were the top takeaways from the interactive metric sessions led by Keith Dorricott at the recent 4th Annual WCTG/MCC Clinical Trial Risk and Performance Management Virtual Collaborative Summit? That’s the key topic explored during Linda Sullivan’s interview with Dorricott, a Master Black Belt and veteran CRO executive who serves as an expert MCC work group leader and contributor. Dorricott discusses outcomes from several Summit breakout group sessions, including, Selection, Implementation and Use of KPIs in a Sponsor-CRO Collaboration and Using Metrics to ID Issues and Drive Improvement Activities. One key takeaway from the Summit, according to Dorricott: the importance of industry alignment on key performance questions, which can then be followed by developing and using metrics to help answer those performance questions. If you don’t have key performance questions, you don’t have the “grounding” necessary to get to the relevant metrics, explains Dorricott. He also described the key learnings from the very popular workshop on using metrics to drive process improvement, which provided participants with a methodology for reviewing metric dashboards and the opportunity to apply their skills to analyze a real-life case study. For more information about how to select the right metrics for your program and use metrics to improve performance, check out MCC’s website, https://metricschampion.org.
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How can small sponsors develop the right strategies to deal with the challenges of aggregating vital trial data? That’s one of the key topics explored during Linda Sullivan’s interview with Rohit Nambisan and Todd Johnson of Lokavant. The guests discuss the difficulties of getting needed data from outside vendors, standardizing the data and implementing the necessary analysis. Some smaller sponsors, the guests explain, historically have not realized the benefits of aggregated data, especially merging historical and ongoing trial data. That planning is far more complex that simply adding columns to a spreadsheet, and sponsors should focus their priorities on the highest possible use cases, the guests add. Finally, the guests say, small sponsors need to consider aggregating and standardizing data (“the new oil”) across multiple studies and CROs, and these sponsors need to negotiate access to this data in their contracts.
For more on this topic, check out MCC’s website, https://metricschampion.org. While you’re there, also check out the upcoming MCC Virtual Summit, at which the guests will be running an interactive session on this topic, www.mcc-summit.com
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How can sponsors with limited resources be most successful in outsource RBQM? That’s one of the key topics explored during Linda Sullivan’s interview with Liz Wool, founder, and president of the Wool Consulting Group. Wool is a recognized industry expert on CRO-vendor oversight and management, certified CRA (ACRP), and an instructional designer, master trainer and expert in delivering virtual training courses that engages the learners. Wool and Sullivan discuss the evolution of risk-based quality management and the regulatory challenges faced by both large and small sponsors. Small sponsors face several problems if they outsource RBQM – they often don’t have the expertise to be an effective partner in RBQM, Wool notes. They need to work with a consultant who can upskill and train them to establish RBQM expectation with their CRO. Key factors in successfully outsourcing RBQM is to work in multi-disciplinary teams, not silos, and to fully understand the methodology being used by the CRO. For more on this topic, check out MCC’s website, https://metricschampion.org. While you’re there, also check out the upcoming MCC Virtual Summit, at which Liz Wool will be running a mini workshop on this topic, www.mcc-summit.com
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