LaTasha Lee, PhD, MPH’s path to becoming a sickle cell disease (SCD) researcher and policy advocate began as a child. Because the SCD trait ran in her family, she became a patient advocate while still small. Today, she is Vice President, Social and Clinical Research & Development, at the National Minority Quality Forum. In this wide-ranging interview, she touches on an array of issues affecting the SCD community. Among them: adult patients who end up in the emergency room, the increased number of available therapeutics and the robust pipeline of SCD therapies. Of particular concern is the challenge of accessing pain medication — both in the ER and in primary care practices. “Individuals with this disease often aren’t believed. They are considered drug seekers when they aren’t.” She also makes a passionate call for increased minority participation in healthcare and in research to enhance equity and improve outcomes. Dr. Lee is responsible for the oversight and implementation of research projects and programs focused on reducing patient risk and identifying optimal care to reduce health disparities and bring about health equity at the National Minority Quality Forum. Before that, she served as Senior Manager of Partnership Engagement of the Sickle Cell Disease Clinical Trials Network (SCD CTN) at the American Society of Hematology (ASH) Research Collaborative. She was responsible for establishing, implementing and maintaining effective partnerships with stakeholders including patients, academic medical centers, other clinical research sites, industry, and federal agencies regarding their interests in SCD CTN. As an experienced research manager at ASH she was tasked with the development of a patient engagement strategy and clinical trials network for SCD. While at ASH, Dr. Lee was also responsible for the day-to-day management and implementation of projects, programs and activities related to ASH’s Call to Action on Sickle Cell Disease.

WCG Institute Podcast: Pioneers of Clinical Research

LaTasha H. Lee, PhD, MPH: Advocating for health equity, advancing sickle cell disease research

Lisa LaLuna has spent three decades in the pharmaceutical industry, and most of that time, she’s been focused on patient engagement and recruitment. Connecting patients to clinical trials is her passion, and in this episode, she discusses why matching patients to clinical trials is essential and how WCG is making it happen. Pharmaceutical companies want to enroll patients. Patients want trials. But too often, they aren’t connecting.CenterWatch iConnect trial finder solves this problem, she explains. It provides a way to help patients find trials. Doing this successfully requires three steps: Educate patients about what a clinical trial entails, make it easy for them to find and connect to a clinical trial, and help them find an accessible trial – e.g.,  not one three states away.CenterWatch iConnect does all three. Patients can also save the trials they’re interested in and share them with their physicians and family.So much is at stake: The first person cured of Alzheimer’s or Parkinson’s or some other now-incurable disease will be in a clinical trial. “Think about that and how powerful that can be.” And then there’s the flipside: “There'll be no cures if patients do not participate in clinical trials, because we just simply won't have the data needed to get these therapies approved and available to patients.”

Lisa LaLuna, WCG Senior VP of Patient Advocacy: Matchmaking to Save Lives

Bernadette Siddiqi, associate director of research partnerships at The Michael J. Fox Foundation for Parkinson’s Research talks about how they give members of the public access to the Fox Trial Finder. This clinical trial search tool that allows anyone to search for Parkinson’s disease clinical trials. More than 300 are listed on the site.It’s a bottleneck in clinical research. Patients are eager for a cure, but it can be difficult for them to connect to trials and for researchers to connect to volunteers.Bernadette speaks of why it is critical to the foundation’s mission to provide an easy way to make this connection. Just as important, she says, is educating people about research. Fox Trial Finder provides both. Roughly 700 people visit the site each month.The Fox Trial Finder is powered by CenterWatch iConnect, and The Michael J. Fox Foundation for Parkinson’s Research is part of growing list of patient advocacy groups that deploy this search tool to inform and empower their patient community.The Michael J. Fox Foundation for Parkinson’s Research is dedicated to finding a cure for Parkinson’s disease through an aggressively funded research agenda.

Connecting Patients to Trials: Bernadette Siddiqi of The Michael J. Fox Foundation for Parkinson’s Research

After more than 25 years working to plan and conduct clinical trials at pharmaceutical companies, Ros Cheetham decided to put herself into the patient role: She volunteered to participate in a COVID vaccine clinical trial.She discusses why she decided to participate in the trial and shares her experiences. So far, it’s all been positive: She speaks of modern methods, safety and the well-organized approach and thoughtful communications used by the clinical research site.She also talks about the barriers, such as distance, that prevent some people from participating in clinical trials, and calls on the industry to help potential participants to overcome those barriers. Studies must be as inclusive as possible so clinical research can benefit a more representative cross-section of our society.She also exhorts individuals to, like her, become clinical trial volunteers. Trials need volunteers, and everyone should have the experience of being in a clinical trial.Cheetham is a pharmaceutical development professional providing expertise in global drug development, global clinical operations solutions and partnership and alliance strategy. Her broad industry experience encompasses several vice president positions. She has led product development teams through successful filings and commercialization of new drugs as well as having implemented innovative global operational solutions that provided cost savings with timely execution and high quality.

Ros Cheetham, Pharmaceutical Industry Professional, Volunteers for a COVID-19 Trial

Movement disorder trials have always been demanding. Now, sponsors face an additional challenge: How do you ensure data integrity in the era of remote clinical trials? In this podcast, Bob Dagher, MD, WCG MedAvante-ProPhase’s Chief Medical Officer, addresses this in conversation with Steve Smith, WCG President of Patient Advocacy. This is the fourth episode in our series, “Transforming CNS Trials During COVID-19—and Beyond.”Sponsors planning to restart movement disorder programs need to be clear-eyed and realistic, Dagher counsels. “When it comes to remote assessments, we have to be vigilant and aware of what we can do and also about what we really cannot do.” Some assessments simply cannot be performed remotely. This means sponsors will need to figure out how to account for variability and missing data in their statistical plan before locking the database.FDA guidance on the conduct of trials during COVID-19 helps provide a roadmap. For example, in the case of anticipated missing data the guidance clearly states to capture specific information in the case report form that explains the relationship to COVID-19. But it also requires in-depth scientific and clinically-informed knowledge so that the quality of the data captured isn’t sacrificed as direct result. Accordingly, WCG has been working with clients to tailor remote assessments for sponsors’ trials, yielding assessments that are as close as possible to the in-person versions (minus those particular items that cannot be done remotely).Dagher’s message? “Ensuring data integrity at every step of the process should be the primary guide for any decision-making process when deciding to restart your study.”Prior to joining WCG MA-PP, Dr. Dagher, was the Chief Medical Officer of Cadent Therapeutics in Cambridge, Mass. Before that, he served in many leadership roles at small and large biopharmaceutical and clinical research organizations, including GlaxoSmithKline, Genzyme, Sanofi and Covance, among others. Dr. Dagher has fostered the development of multiple products in different indications and development platforms and advanced several small molecules and biologics across all stages of clinical development. His background includes therapeutic experience in psychiatry, neurology and rare diseases.

On the Future of Movement Disorder Trials: Part 4 of WCG’s Transforming CNS Trials Series

As a global strategist for Intel’s Health and Life Sciences Group, Bryce Olson had an up close view of innovation happening in the lab—especially in terms of genomic sequencing and gene therapy. As a man diagnosed with aggressive stage 4 prostate cancer at 44, he had as well an up close view of how that innovation was not being translated into the clinic.  He was started on a one-size-fits-all standard of care. It didn’t work, and chemo made him ill. In this podcast episode, he talks about how he demanded—and received—DNA sequencing. That data led him to find the right trial and the right medicine for his type of prostate cancer. He’s now a very vocal advocate of sequencing. Among other endeavors, he founded Sequence Me (www.sequenceme.org), a patient-driven movement to accelerate access and adoption of new genomic sequencing innovations for cancer.

Prostate Cancer Survivor Bryce Olson’s Message: “Sequence Me!”

In major depressive disorder, researchers have used remote assessments for decades. As a result, many of these studies have had an easier time adapting to the new clinical trial landscape. But that doesn’t mean they are pandemic-proof. So what are the critical success factors for clinical depression programs—especially now?  In his conversation with WCG President of Patient Advocacy Steve Smith, Mark Opler, PhD, MPH, Chief Research Officer at WCG MedAvante-ProPhase offers his insights on the future of clinical depression trials. This is the third episode in our podcast series, “Transforming CNS Trials During COVID-19—and Beyond.”We’re headed in the right direction by enabling more patient-friendly evaluation, but – especially in light of the pandemic – we must continue to refine these systems and make sure that we have the input of patients, caregivers, and of course, investigators. Among his recommendations: Ensure clinicians have the right depression-assessment tools and that they are using them correctly. It’s also critical, he says, to have a solid remote assessment methodology in place. This means not only incorporating the right tools, but also establishing a way of continuously protecting data quality, such as WCG's Study Insight Analytics Platform.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.

On the Future of Depression Trials: Part 3 of WCG’s Transforming CNS Trials Series

At 51, Jeffrey Borghoff was diagnosed with Alzheimer’s disease. What would devastate many people turned Borghoff into an advocate. The former software architect and developer is now a national spokesperson for the Alzheimer's Association and board member of the Greater New Jersey chapter.In this podcast, he talks about how the diagnosis forced him to reprioritize his life. “I've been pretty successful at that. I've been leading a very purposeful, engaging, joyful life.” With his care partner—his wife, Kimberly—he travels around the country making the case for research funding—and for clinical trial participation. That’s critical because important Alzheimer’s trials focus on younger-onset AD patients. Unfortunately, many people who are beginning to show signs at a very young age want to deny they have the disease. They won’t go into trials or even get a diagnosis. His messages to them: This disease does not define who you are, and research is important.

Jeffrey Borghoff: Finding Joy and Purpose after an Early-onset Alzheimer’s Diagnosis

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.

On the Future of Schizophrenia Trials: Part 2 of WCG’s Transforming CNS Trials Series

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.

Lisa Deck: Young Stroke Survivor Transforms Life-altering Challenge into Purpose-driven Advocacy for Others

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. 

The Case for Centralized Monitoring: Optimizing Data Quality and Risk Management with Linda Sullivan and Steve Young

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. 

Michael Poku, MD, MBA: Implements solutions to improve minority representation in clinical trials

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.

Dana Deighton: Esophageal Cancer Patient and Persistent Activist For Her Own Survival

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. 

Striving for Reliability: Optimizing Patient Report Data through World-Class Design Management with Linda Sullivan, Nat Katz, and Art Morales

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.

The Upside of Centralized Monitoring During a Pandemic: Linda Sullivan, Duncan Hall, and Rachel Oakley on Optimizing Clinical Trials through Innovative RBQM Technology

Insights from leaders in clinical research and trial optimization, hosted by the WCG Institute.

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LaTasha H. Lee, PhD, MPH: Advocating for health equity, adva...

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