Remote assessments have become a necessity across CNS trials, but some areas are more complicated than others. Schizophrenia provides one such example; the risk of variability is high, and sponsors are concerned. In this podcast, Mark Opler, PhD, MPH, Chief Research Officer at WCG MedAvante-ProPhase, sits down with WCG President of Patient Advocacy Steve Smith to discuss the topic. This is the second episode in our podcast series, “Transforming CNS Trials During COVID-19—and Beyond.”

PANSS—the gold standard rating scale for schizophrenia primary outcomes—is based largely on face-to-face interviews; it wasn’t developed for remote assessments. Is it still usable? Yes, says Dr. Opler. “I’m pleased to report that the anecdotal experience, as well as available data, suggests assessments conducted with patients with schizophrenia via video can be done reliably and can be done in a way that produces valid data.”

It can be done—the tools exist. But it’s the way sponsors and CROs approach remote assessments that can make or break data integrity—and he delves into that topic in this podcast. In particular, he shares how sponsors and CROs can leverage remote assessments in their next clinical trial.

Mark Opler, PhD, MPH, is Chief Research Officer at WCG MedAvante-ProPhase. Dr. Opler was the founder of ProPhase and served as its CEO and Chief Scientific Officer, among other roles. He serves as adjunct assistant professor of psychiatry at New York University and assistant professor of clinical neuroscience at Columbia University’s College of Physicians and Surgeons. He is also leading the development of the forthcoming edition of the PANSS Manual.

Lisa Deck was a healthy 21-year old a week away from college graduation when her first stroke put her in the hospital. She barely made it to her graduation ceremony. She suffered two more strokes before she turned 25, and after that, a fourth stroke.

After serious misdiagnosis and incorrect treatments, she was finally diagnosed with Moyamoya disease, a rare condition without a cure, but it does have a surgical treatment.
 
In this podcast, she shares her diagnostic odyssey, her commitment to advocacy and the value of peer and family support. She also talks about the importance of staying positive and why patients must advocate for themselves.

How can CROs and sponsors detect potential problems and issues in clinical trial conduct and data quality? That’s one of the critical issues discussed in Steve Young’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Young, Chief Scientific Officer at CluePoint, discusses how risk-based quality management (RBQM) methodology, data analytics, and data surveillance are being utilized today to go beyond just ferreting out fraud.  Now, Young says, clinical trial stakeholders are deploying advanced statistical engines to detect quality and data breaches in investigational studies. According to Young, while there are still instances, to varying degrees, of major misconduct in clinical trials, CROs and sponsors are increasingly turning to online solutions to risk planning. It’s important, he adds, that when risks are discovered, the solutions are integrated into the workflow of clinical trials. In fact, Young asserts, one of the biggest challenges facing the industry today is to embrace change and accept the use of centralized monitoring data to aid in the discovery and resolution of risk.        

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. 

For many of the same reasons underrepresented populations lack access to appropriate healthcare services, they are also left out of clinical trials. The problem is widely known, but solutions have been hard to come by. In this episode, Michael Poku, MD, MBA, biopharma medical director at Signify Health, explains why this is the case and then shares some approaches he and his colleagues have successfully used to remove the barriers to clinical trial participation.

An important aspect is understanding the larger picture—that inequality is due to in large measure to longstanding and systemic issues. He discusses how unmet social needs rarely occur in isolation. Addressing those needs together can lead to better representation in clinical trials. 

“Sponsors are incredibly excited about opportunities to make their trials more representative and to have underrepresented minorities participate,” he says.

In addition to his work at Signify Health, Dr. Poku is on clinical faculty at Methodist Dallas Medical Center and the University of Texas Southwestern Medical Center, where he cares for patients as an internist and teaches trainees and medical students. Prior to his role at Signify Health, Dr Poku was a consultant at McKinsey & Company.

Dana Deighton, an esophageal cancer survivor, shares her diagnostic odyssey of false starts and life-threatening detours.

Deighton had always been healthy—she didn’t smoke, didn’t drink and exercised every day. Then came a joint pain that wouldn’t go away, visits to numerous doctors, a series of misdiagnoses, invasive tests, and growing symptoms. The correct diagnosis of stage 4 esophageal cancer “was not the diagnosis anyone wants.” But she refused to accept physicians’ recommendations for palliative care as a solution.

She describes her persistent advocacy to convince doctors to consider her as an individual different from expectations and generalizations. She asked the hard questions and had the hard discussions, resulting in an outcome better than expected.

She recommends physicians and patients do the homework, energetically collaborate and consider the individual patient in the quest for a solution. “Don’t be a passive patient.”

Dana Deighton works for the online patient community provider Inspire.com that helps connect patients with others experiencing the same disease, for a wide variety of diseases and over 4 million members.  She also serves as an Executive Board Member of the Esophageal Cancer Action Network (ECAN), is a patient representative on the Locally Advanced Esophageal Cancer Guideline Panel for the American Society of Clinical Oncology (ASCO), a member of NCI Patient Advocate Steering Committee and NCI Esophago-Gastric Task Force and serves on the Esophageal and Stomach Cancer Project Patient Advisory Committee, a project led by the Broad Institute of MIT and Harvard. She lives outside of Alexandria with her husband and three teenagers.

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. 

Ever since elementary school, Gregory L. Hall, MD, knew he would be a doctor. In this interview, he shares that journey and how he came to write the book—literally—on health disparities for African Americans.

His focus on disparities began more than 30 years ago with his appointment to the Ohio Commission on Minority Health—the first such commission in the country. Eventually, when he became the chairman, he had to give quarterly reports. The research he conducted on disparities for those reports opened his eyes, he says.

“I naively believed that providers and physicians didn’t contribute to health disparities. I thought it was just poverty and a lack of insurance. I didn’t know that, actually, providers contribute to it, health systems contribute to it.” He was shocked, and what he learned led to him write his book, Patient-Centered Clinical Care for African Americans: A Concise, Evidence-Based Guide to Important Differences and Better Outcomes. It is for physicians and clinicians and is a guide outlining specific differences in communication, clinical therapies, medications, protocols and other critical approaches to the care of African Americans.

The book discusses a wide range of disorders that affect African Americans It includes clinical pearls, but it also provides the background clinicians need to understand just what drives disparities.

Providers don’t want to exacerbate disparities, but they are often unaware. If you don’t know what you’re doing wrong, you can’t fix it, he says. He is helping with both. 

Even when providers do a better job addressing the specific needs of African-American patients, hurdles remain, he says. For example, lack of trust remains a huge issue among African-American patients; the shadow of historic discrimination in medical settings looms large. Almost half of African Americans report low trust of healthcare providers—and what’s interesting, he notes, is that this distrust extends to providers of all races. As a result, African Americans often don’t seek out the care they need, and they are wary of clinical trials.

In addition to being a practicing primary care physician in Cleveland, Dr. Hall has a dual appointment on the teaching faculty at Northeast Ohio Medical University College of Medicine as associate professor of both internal medicine and integrative medical sciences. He also has an assistant clinical professor appointment at the Case Western Reserve University School of Medicine. 

"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.