Clinical Trial Optimization

Can patients be trained to report their symptoms more accurately? That’s one of the key topics discussed in Nat Katz’s and Art Morales’ interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Katz, the Chief Science Officer of WCG-Analgesic Solutions and Morales, Vice President, Technology Solutions at WCG, assert that, with proper design and implementation, you can structure clinical trials, such as pain management studies, so that patients learn how to better report their symptoms. With proper training, patients learn to accurately report their symptoms, resulting in more reliable data, according to Katz and Morales. During COVID-19, they add, sponsors have had the opportunity to examine ways to introduce new technologies, such as telehealth, to clinical trial operations and to use more science-based tools for evaluating the performance of clinical trials. COVID-19 also has accelerated the scientific evaluation of clinical sites by optimizing the analysis of patient data. The result: Clearer and more reliable data collected during the conduct of study — without unblinding the data.

Interested in attending the MCC Clinical Trial Risk and Performance Management vSummit Sept. 8-10? Visit https://www.centerwatch.com/mcc-summit-2020. If you subscribe to this podcast, you can use the code POD15 to receive 15% off your registration fee.

How are clinical trial companies pivoting to implement Risk-Based Quality Management programs during the pandemic? That’s one of the deep dives explored in Duncan Hall’s and Rachel Oakley’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Hall, founder and CEO of Triumph Research Intelligence (TRI) and Oakley, Vice President of RBQM Services at TRI, note that, when the COVID-19 pandemic first hit, CROs and sites performed risk assessments on their existing studies. Then those organizations took advantage of innovative technology that had a key tool for optimizing clinical trials — centralized monitoring. According to Hall and Oakley, that tool enables critical oversight and monitoring of investigational sites, even when in-person visits are not feasible. They point out that regulatory agencies are issuing new guidance during the pandemic, and that sponsors, CROs, and sites need to figure out how to comply with both those new mandates as well as existing rules. According to Hall and Oakley, there has been a renewed sense of community in the industry in dealing with the pandemic as stakeholders try to stay current through a variety of trusted sources, including MCC’s weekly COVID calls. Finally, they note, one component for optimizing clinical trials is taking center stage — training, especially in the area of RBQM.

Interested in attending the MCC Clinical Trial Risk and Performance Management vSummit Sept. 8-10? Visit https://www.centerwatch.com/mcc-summit-2020.

If you subscribe to this podcast, you can use the code POD15 to receive 15% off your registration fee.

What’s the secret to success for implementing a world-class holistic approach to a Risk-Based Quality Management (RBQM) system? That’s one of the key topics from Artem Andrianov‘s and Johanna Proeve’s interview with Executive Director of WCG’s Metric Champion Consortium (MCC), Linda Sullivan, MBA. Andrianov, CEO, and Proeve, Chief Science Officer at Cyntegrity emphasize the importance of developing a clinical trial platform that enables your organization to manage the entire quality management cycle rather than continuing with traditional silo-based approaches. This comprehensive approach, they explain, enables pharmaceutical companies to become more efficient in reducing risk, which is especially important during the current pandemic. In addition, they note, in the COVID-19 era, more organizations have had to turn to holistic risk-based quality management systems because, for example, Excel doesn’t always work for managing RBQM, especially in larger clinical trials. Today, both CROs and sponsors are implementing innovative RBQM technology and asking for additional training to deal with data quality deterioration and other issues brought about by the onslaught of the pandemic, according to Andrianov and Proeve. Listen to this episode to find out how COVID-19 has magnified festering clinical trial shortcomings and why it’s essential that pharmaceutical company leaders become “data scientists.”

Interested in attending the MCC Clinical Trial Risk and Performance Management vSummit Sept. 8-10? Visit https://www.centerwatch.com/mcc-summit-2020.

If you subscribe to this podcast, you can use the code POD15 to receive 15% off your registration fee.

"What impact does a remote clinical team operating model have on clinical trial performance?" That’s one of the hot topics from Ken Getz’s interview with Executive Director of WCG’s Metric Champion Consortium (MCC), Linda Sullivan, MBA. He describes several projects that the Tufts Center for the Study of Drug Development (Tufts CSDD) is currently working on; ones that will provide robust, data-driven analysis and strategic insights that help drug development professionals improve pharmaceutical R&D. Getz is the Deputy Director of Tufts CSDD and Professor at the Tufts University School of Medicine.

At any given time, Getz states that Tufts is conducting between 12 and 15 grant-funded projects. The ideas for their studies are often generated from conversations in working groups, like MCC’s member networks. They also arise from thought-provoking conversations at industry conferences. But no matter where the studies come from, the studies always provide a “think tank for that very high-level, macro-level view of what’s happening in drug development,” Getz explains.

Listen to this podcast to learn how Tufts – and the data it publishes – offers insights for organizations to transform clinical trials. “Everyone I speak with tells me they’ve tried to measure and benchmark. There are lots of internal forces that have tried to tackle benchmarking, so we’re excited to have an evidence-based approach that provides an opportunity to help organizations shape their practices moving forward.”

Interested in attending the MCC Clinical Trial Risk and Performance Management vSummit September 8-10? Visit https://www.centerwatch.com/mcc-summit-2020.

If you subscribe to this podcast, you can use the code POD15 to receive 15% off your registration fee.

In this episode, host Linda Sullivan, MBA, Executive Director of WCG's Metric Champion Consortium (MCC) chats with Laurie Halloran, founder of the Halloran Consulting Group, about how she developed an on-demand drug development team that can fill in gaps in the clinical trial process for life science companies, whether these involve regulatory strategy or execution, or quality, clinical, or manufacturing issues. The COVID-19 pandemic has resulted in these companies having to pivot to more virtual experiences. At the beginning of the outbreak, she notes, her group organized town halls that made it clear to stakeholders that life science companies had to implement telehealth and other remote monitoring solutions to protect patient safety. As a result of the pandemic, Halloran explains, her group is reviewing clinical trial protocols to determine how technology can be better utilized in the collection of clinical trial data. In conclusion, Halloran says, “don’t waste this opportunity” to make your clinical trial program more resilient.

Interested in attending the MCC Clinical Trial Risk and Performance Management vSummit September 8-10? Visit https://www.centerwatch.com/mcc-summit-2020

If you subscribe to this podcast, you can use the code POD15 to receive 15% off your registration fee.