WCG Talks Trials

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.

Pharmaceutical executive Peter A. DiBiaso, MHA, a triathlete who has successfully completed the grueling Ironman, learned at age 49 he had early-onset Parkinson’s disease. He shares his experiences—and triumphs—in this episode.

What started as a small tremor in his right hand and a stiffness in his right ankle ended up changing his life. 

It was a blow, but he knew what to do: The diagnosis brought his personal and professional life full circle. Five years later, he reports minimal disease progression. He is doing well and remains incredibly active. Other than well-managed medication, to what does he attribute his success so far?

• Staying fit and continuing to be an athlete. He is still running marathons and recently scaled Mount Kilimanjaro, the highest mountain in Africa.
• Engaging with patient advocacy groups—in particular, the Michael J. Fox Foundation. (In fact, his Kilimanjaro trek was part of a Team Fox effort to raise money for the foundation.)
• His ability to navigate the system. 

He has also been involved in six clinical trials—both interventional and observational. He knew the value as an industry insider. Now, he appreciates the value from the patient perspective—and he better understands the frustrations patients face. It too often falls on the patients to initiate discussions about clinical trials. That’s fine for him, he says, but what about those who don’t know trials are available?

His professional life has focused on patient recruitment issues, so he brings a 360-degree perspective. Sponsors, he says, need to focus on more than the academic and clinical elements; they must address real-world issues and trial participants’ challenges—even those that seem minor, like parking.

It comes down to patient-centricity, he explains—putting patients at the center of the clinical research enterprise. It is becoming more common, but there’s still a long way to go.

Peter DiBiaso, MHA, is a consultant to drug development companies and has worked at Pfizer, Shire, Vertex, and IQVIA. He is married and has two children, and he and his family split their time between Paris and Boston.

Lisa Carlton, PhD, understands rare childhood diseases both professionally and personally. She was already a scientist specializing in rare diseases when her daughter was diagnosed with one: tuberous sclerosis. As VP of Global Regulatory Affairs for a biotech drug developer she is involved in development of treatments for other rare diseases too. This makes her an ideal person to co-chair an industry-patient-advocacy group called the Working Group on Regulatory Science, a part of the EveryLife Foundation for Rare Disorders that seeks to advance the development of treatment and diagnostic opportunities for rare disease patients through science-driven public policy.

Tuberous sclerosis, a rare genetic disorder, affects one in every 6,000 newborns in the United States. It is a disorder that causes benign growth in almost any tissue; it’s of particular concern when it occurs in the brain, lungs or kidneys. Some people who have tuberous sclerosis may have learning problems or difficult-to-control seizures. Her daughter—one of a pair of twins—was diagnosed in utero. She’s doing well, although the speech and language disorders associated with the condition have made it hard to access the curriculum in school.

Dr. Carlton talks about the challenges of developing new treatments for rare diseases and the approaches taken to try to overcome them. She also talks about her daughter’s disease, and how families can bring their best to their journey as they adapt to support their child. Based on her experience as a parent and advocate—as well as her experience in the industry—she has this advice for families: “Take a breath.” Drug development is slow, especially in rare diseases. “You are in for a marathon of supporting your child.”

When possible, connect with other parents and advocacy groups. Or build your own tribe—work, friends, family, etc. “You have to be healthy and rested enough to do this. You have to be at your best.”

She’s often asked how she manages to keep going. “I don’t know how I wouldn’t do it. You’ve been given this gift of a special child.  Now it’s time to find your tribe and push ahead.”

Her advice for a biotech company considering launch of a clinical trial for a rare disease? Nobody knows more about a patient’s journey, the patient’s experience, than the patient—or a parent or caregiver. “Just listen to what patients are saying. You are going to learn a lot.”

Lisa Carlton, PhD, has previously worked in regulatory roles at the National Institutes of Health, Otsuka Pharmaceuticals and International Partnership for Microbicides. She is currently serving as Vice President of Global Regulatory Affairs at REGENXBIO, a gene therapy-focused biotech company with headquarters in Rockville, MD. Lisa received her PhD in Pharmaceutics and MS in Medicinal Chemistry from the University of North Carolina in Chapel Hill and a BS in Biochemistry from North Carolina State University.

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. 

To fully engage Chicago’s medically underserved Chinese and other Asian communities and to help them address their own health issues, Dr. Hong Liu’s Midwest Asian Health Association reaches out in Mandarin, Cantonese and other languages—and does so in culturally appropriate ways.

The result is better access to healthcare for many low-income, often new-immigrant minorities who experience certain health problems in higher prevalence than the general population including hepatitis, liver cancer, diabetes, hypertension, heart disease and mental illness. 

She and her team engage people to participate in education, screening and diagnostic services, and counseling. They also partner with hospitals, medical professionals, medical schools and drug companies to connect community members with care. Too often, she says, many don’t know what’s available, and for cultural reasons they don’t access the systems that are available to them. In many cases, the emergency department is their first stop for healthcare, and their diseases are too advanced by the time they seek it. 

She talked about how her community has faced increased discrimination and harassment due to misinformation about COVID. She gives a more accurate look into the community’s nature as she describes how Chicago’s Asian-American community raised money, then used it to provide personal protective equipment to hospitals and clinics all over the Chicagoland area. Members of the community felt strongly that they wanted to demonstrate their pride and gratitude to be a part of the United States. The management of many of the hospitals sent letters of thanks, letting them know their gesture was most welcome and appreciated. 

Dr Liu’s work has earned the respect of healthcare providers, the Asian-American community, and local, state and federal health agencies. In 2016 she was invited to the White House by President Barack Obama in recognition of her work. 

Dr. Liu has a PhD in Public Policy Analysis from the University of Illinois in Chicago. 

In this episode, Roslyn Daniels, the founder and president of Black Health Matters, talks about how her organization educates and motivates African-American communities about taking care of one’s own health.

Seeing her own grandparents die too soon and recognizing that, in many communities,  people are forced to choose between rent and healthcare, she realized that “access means nothing unless you have an understanding of the fundamentals of good health.”   

Using her background in media and direct-to-consumer marketing, Daniels established Black Health Matters. Its online presence and social media activity generate excitement in the public, presenting easy-to-digest information in a positive, upbeat way that appeals to a wide range of ages and interests. Its live events feature a stellar lineup of leading healthcare experts.

The 4th Annual Black Health Matters Summit will be hosted online July 18, 2020. The public can access this event free by checking out www.blackhealthmatters.com on July 18 and after that date as well. It will feature videos, resources and a lineup of featured speakers, including Michelle Obama.

In addition to her role with Black Health Matters, Daniels consults with the pharmaceutical industry. She has an extensive background in media and marketing, including director of business development for BET Networks. She also spearheaded the launch of Fitness magazine. She is a graduate of Boston University.

Our guest this episode, patient advocate Dorelia Rivera, improves access to healthcare services and clinical trials for the underrepresented, including her own Hispanic community. Her advocacy ranges from community volunteer work, to jobs for a state health and human services department, a payor, and a rare disease drug company. She advocates on Capitol Hill and served on the National Institutes of Health Advisory Council on Diversity 

She’s also a mother of a child with a rare disease. Rivera’s daughter has an ultra-rare condition, NOMID--neonatal onset multisystem inflammatory disease. When she was first diagnosed, the doctor said she wouldn’t live to be 10 years old. Today, she is thriving teenager, thanks to an NIH clinical trial and her mother’s persistence. 

Rivera talks about her daughter and her advocacy for underserved communities. Like those with rare diseases, racial and ethnic minorities are too often overlooked.

“Health disparities are real,” she says. The COVID-19 pandemic and the current protests are driving that home, she adds. “It’s painfully, painfully, painfully evident.” Changes need to be made concurrently across several areas, including insurance coverage, access to care, access to clinical trials, and a greater focus on the social determinants of health. “Healthcare should be a right, not a privilege.”

In terms of clinical trials, sponsors need to understand the barriers many patients--especially those in minority communities--face. Someone who needs to leave work to participate in a trial may not have a job when they return. Too often, trial sponsors aren’t flexible in addressing the obstacles potential participants face. If sponsors want to improve diversity, they need to level the playing field. “They have to meet the families where they are.” 

“Our research population should match our community population.” That’s one of the takeaways from Christopher Gantz’s interview with WCG President of Patient Advocacy Steve Smith. He describes several programs that help connect researchers with minority communities to increase engagement and access enrollment in clinical trials. Gantz is senior director of the Regional Liaison Office at the Sidney Kimmel Cancer Center (SKCC) at Thomas Jefferson Hospital in Philadelphia. 

Since 2005, he has worked on multiple clinical trials projects with recruitment goals ranging from 500 to 10,000 participants. He describes establishing an “honest broker network” and engagement of resources within the hospital and within the community to ease communication, build trust and facilitate trial enrollment. He also discusses some of SKCC’s language and cultural resources as well as its outreach into area schools.

Listen to learn how SKCC’s success offers a model for other organizations to transform clinical trials. “We have so many resources and so many opportunities to engage with people. I think if we're smart about it and really thoughtful in how we do it and create these longstanding relationships, it really will create a change.”