WCG Talks Trials

In this episode, we learn about CISCRP’s AWARE for All campaign, which builds awareness of, creates access to and encourages participation in clinical trials. Ellyn Getz, Associate Director of Development and Community Engagement at CISCRP, The Center for Information and Study on Clinical Research Participation, discusses AWARE for All.

CISCRP's flagship grassroots campaign works with diverse communities around the world to build a greater awareness and understanding of the clinical research process and the role that participation plays in advancing public health. This program is a response to health disparities in these communities—disparities rooted in the long-standing lack of access to healthcare, and gaps in understanding between these communities and the healthcare system.

Each AWARE for All event brings together a diverse array of stakeholders, including community groups, local researchers, patient advocates and community members. “Hearing from local study volunteers and local researchers is one of the most uplifting parts of this program, especially if [attendees] can hear about breakthroughs or really exciting developments and advancements in research that are taking place in their own community,” she reports.

Weeks of planning with community leaders culminates in a free community health event. Although usually done onsite and in person, the next event, on July 16, will be virtual. This will allow people to watch it live or access the information later. In addition to presentations, it will include a virtual exhibit fair with community health assessments. Details are available here: awareforall.org.

Independent expert committees provide essential validation of clinical data. Without their insights, sponsors risk missed signals, conflicts of interest and costly delays. But establishing a successful expert committee can be tricky. It requires the right combination of people, process and technology. In this three-part podcast, Lakshmi Sundar, head of business transformation at WCG ACI Clinical, explores each of these with a WCG ACI expert.

In the first part of the series, Bill Stedman, manager of member services, shares his perspective on the “people” aspect. He discusses how success rests on having the right combination of expertise. Then, Dr. Bindi Shah, chief medical officer, explains how proper processes are critical to setting and running up expert committees. In the final part of the series, Mandy Moran, manager, innovation and technology, discusses how, when deployed correctly, technology supports the people and the process, allowing committee members do what they do best and do it efficiently.

In this episode, Dolly Niles, executive director of QUEST Research Institute, talks about the role of small research sites and the value of community outreach. QUEST, a multi-specialty independent research site in metro Detroit, has conducted more than 350 phase 1-4 trials since it was established in 1996.

Niles talks about the role of agile smaller sites during the height of the COVID-19 pandemic. Many health systems and academic medical centers reassigned research staff to patient floors. Smaller sites like QUEST Research Institute have been able to step up, contract quickly and stand up new studies while completing current ones. 

She also touches on the importance of connecting with the local community--including minority communities. The fact that COVID-19 is hitting minority populations particularly hard “highlights something we already know--that minority communities are underrepresented in clinical research,” she says. “Sites need to spend time figuring out how to crack that nut.”

The issue goes far beyond recruitment, she says. It requires educating patients and physicians about clinical trials. It involves establishing a trust relationship so when it’s time to recruit, potential participants have that relationship and want to know more. “We need to figure out how to make time for that.” 

In this episode, Brian Loew, founder and CEO of online patient portal Inspire, talks about the value to patients and caregivers of providing a safe and trustworthy online social network--a “peaceable kingdom,” as he calls it.

Millions of patients representing 3,500 diseases--including many rare ones --come to Inspire.com for online community discussions focused on their own particular disease. The platform provides a place for meaningful conversations among patients and caregivers. It also allows them to share their insights in ways that advance clinical research. Patients want to support research, sometimes even initiating it themselves. And, more than ever, Loew says, researchers are interested in patient-reported information. If patients agree, they can also be connected to relevant clinical trials. 

Loew emphasizes that across all the conditions and forums, patients always have control over what data they share and where they share it--and in his experience, the more control they have, the more willing they are to share it. 

The recently added coronavirus section (www.inspire.com/coronavirus) also features video testimonials from patients with a variety of conditions describing why COVID-19 is disrupting their medical routines and threatening their health.

Loew is a frequent speaker and writer on the topics of health-focused social networks and digital health. He sits on the boards of the Robert Packard Center for ALS Research at Johns Hopkins, and New Jersey Goals of Care. He was a “Red Jacket” recipient from PharmaVOICE magazine for his contributions to the industry.

In this episode, Brian Loew, founder and CEO of online patient portal Inspire, talks about the value to patients and caregivers of providing a safe and trustworthy online social network: a “peaceable kingdom,” as he calls it.

Millions of patients representing 3,500 diseases—including many rare ones—come to Inspire.com for online community discussions focused on their own particular disease. The platform provides a place for meaningful conversations among patients and caregivers. It also allows them to share their insights in ways that advance clinical research. Patients want to support research, sometimes even initiating it themselves. And, more than ever, Loew says, researchers are interested in patient-reported information. If patients agree, they can also be connected to relevant clinical trials. 

Loew emphasizes that across all the conditions and forums, patients always have control over what data they share and where they share it—and in his experience, the more control they have, the more willing they are to share it. 

The recently added coronavirus section (Inspire.com/coronavirus) also features video testimonials from patients with a variety of conditions describing why COVID-19 is disrupting their medical routines and threatening their health.

Loew is a frequent speaker and writer on the topics of health-focused social networks and digital health. He sits on the boards of the Robert Packard Center for ALS Research at Johns Hopkins, and New Jersey Goals of Care. He was a “Red Jacket” recipient from PharmaVOICE magazine for his contributions to the industry. 

Drug policy has transformed to bring transformative improvement to the way rare diseases are developed resulting in more FDA approved treatments.

This transformation came about because of collaboration across stakeholders: patient advocates, the FDA, Congress, drug developers, researchers, and legal specialists.  Profound change came in the mid 1980’s when AIDS activists, Rare Disease Activists, and others found ways to use policy to accelerate development of FDA approved treatments.

Legal specialists Frank Sasinowski of Hymen Phelps and McNamara has always been a champion of the patient voice in legislative change, drug development policy, and FDA approvals.

In this WCG Patient Radio episode with WCG’s President of Patient Advocacy, Steve Smith, Mr. Sasinowski speaks of the transition from a time in the late 90s when patients were not even considered in drug policy.  He speaks of formalization of the patient voice into legislation, the Rare Disease Congressional Caucus, Patient-Centric Drug Development program at the FDA, and numerous other transformative mechanisms.  Change is evident as we now see many patient-focused roles within drug development companies, working with more sophisticated patient advocacy groups, and regulators.

During this 20 minute podcast, Mr. Sasinowski also discusses the balance between the need for speed of drug development, with safety, and the concept of “certainty.” How can we include, in the drug approval process, the concept of “risk vs. benefit” as seen by patients that are in need of a therapy very soon who are willing to take more risk. 

In this podcast, Thomas Farrington, founder of the Prostate Health Network, speaks with WCG President of Patient Advocacy Steve Smith.

Mr. Farrington discusses his experience with the healthcare system, coupled with his own research on prostate cancer, which led him to become a vocal advocate for prostate cancer patients and survivors. His advocacy spans a wide range of approaches from educational seminars, a frequently-visited website, a theater production called Daddy’s Boy that is now on tour, and visits to legislators on Capitol Hill to help shape public policy for the benefit of people with this unmet medical need.

Mr. Farrington also serves as a trustee of the Dana Farber Cancer Institute and as an advisor to a number of other healthcare organizations and programs, and he is on the National Comprehensive Cancer Network’s prostate cancer treatment guidelines panel and their prostate cancer early-detection guidelines panel.

In this episode, former Assistant FDA Commissioner Jonca Bull, MD, discusses racial disparities in healthcare, how COVID-19 has made them impossible to ignore, and how this highlights the need for diversity in clinical trials.

Low-income minority communities are being hit disproportionately hard by COVID-19. Dr. Bull isn’t surprised: The current crisis has simply magnified existing disparities. A multitude of factors are at play, including lack of access to healthcare and healthful food. As a result of these and other issues, certain underlying health conditions are more prevalent in low-income minority communities. 

Clinical trials must include these populations so we can truly understand COVID-19 and how to treat it in real-world conditions.

In fact, the FDA has long had guidance on how to make trials more diverse:

• Collection of Race and Ethnicity Data in Clinical Trials—Guidance for Industry and Food and Drug Administration Staff
• Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry 

She emphasizes that African Americans are willing--sometimes more willing than others--to participate in clinical trials. But they must be invited, and trials must be designed with consideration of the obstacles they face because of where they live and how they work.

Dr. Bull serves as a consultant focused on drug development and regulatory considerations; she helps guide the strategic development and implementation of clinical trial protocols. She has served in various roles, including as assistant commissioner at FDA with a focus on diverse populations and clinical trials.

This episode takes on a topic from recent headlines--namely, the racial disparity in COVID-19 cases and deaths. Edith P. Mitchell, MD, MACP, FCPP, shares her insights on the causes of these health disparities and how they relate to the coronavirus. Contributing factors include less access to testing, lack of insurance and paid time off, underlying health conditions, and the spread of misinformation about the virus.

She also touches on how racial disparities affect clinical research. “When I came to Philadelphia, we had only 7.8% participation by African Americans in clinical trials. Yet 45% of Philadelphia is African American. We have been able to raise the participation in clinical trials to a high of 24.9%, and maintain a range around 20%,” she tells WCG President of Patient Advocacy Steve Smith. “Never assume African Americans don’t want to participate in clinical trials. They must be invited, and there must be cultural competence among healthcare providers.”

Dr. Mitchell is clinical professor of medicine and medical oncology, Department of Medical Oncology; director, Center to Eliminate Cancer Disparities; and associate director, Diversity Affairs, at Sidney Kimmel Cancer Center at Thomas Jefferson University in Philadelphia. She is also a retired U.S. Air Force Brigadier General.

In this COVID-19 focused episode, Dr. David Fajgenbaum chats with President of WCG Patient Advocacy, Steve Smith, to talk about his journey as a medical researcher and patient of a rare disease and about the pandemic facing our daily lives. Known for his best-selling book, Chasing My Cure: Turning Hope Into Action, Dr. Fajgenbaum shares best practices for how everyone facing this crisis can get through these scary and trying times together as a community via hope, prayer, action, humor, and the ability to create silver linings.  

Their discussion also highlights the importance of social distancing for patients with a compromised immune system during COVID-19, the fast-paced nature of research at Dr. Fajgenbaum’s institute, and the advantages of drug repurposing. 

For more information on drug repurposing Dr. Fajgenbaum and his team are leading, please visit https://cdcn.org/drug-repurposing/.