In episode two of WCG Talks Trials, we are joined by two WCG experts to discuss overcoming common enrollment challenges and how DE&I, technology, and protocol design factor into enrollment success.

Listen in as we delve into the critical topic of common enrollment barriers in clinical trials, how to improve enrollment by focusing on DE&I efforts, the importance of site-centric and patient-centric technologies, and how thoughtful protocol design plays a significant role in enrollment success.

Speakers:

• Dawn Sauro, Chief Growth Officer, WCG
• Jamie Harper, MHA, CCRP - Vice President, Site Solutions & Engagement at WCG
• Tyler Bye - Director, Site Solutions & Product Strategy at WCG

In the first episode of our new podcast series, WCG Talks Trials, we are joined by three industry experts, Lisa Ballance from Virginia Commonwealth University, John Musser from Florida Cancer Specialists and Research Institute, and Dan Otap from Genentech, to discuss the topic of overcoming site challenges and addressing site burden.

Listen in as we discuss the results of WCG’s recently published 2023 Clinical Research Site Challenges Survey Report, gain insights from our guests on solutions their organizations have implemented to reduce site burden, and share perspectives on how sites, sponsors, and CROs can work to improve site and trial efficiency.

Speakers: 

• Sandy Smith, RN, MSN, AOCN 
  Senior Vice President, Clinical Solutions and Strategic Partnerships at WCG Clinical
• Lisa Richman Balance
  Associate Vice President for Research Strategy and Regulatory Affairs at Virginia Commonwealth University 
• John Musser
  Senior Director, Clinical Research Administration at Florida Cancer Specialists & Research Institute
• Dan Otap
  Principal, Alliance and Partnerships Lead at Genentech

From a career devoted to finding better ways to connect patient volunteers to clinical trials, Lisa LaLuna knows why the public needed an online search tool that is easier to use than the traditional methods of access.

“Members of the public often want to find a trial to access the latest medicine, or help a family member, or just to participate as a healthy volunteer to further medical research.  Pharmaceutical companies that run clinical trials of course want to enroll patients so their research can be successful.  In spite of this mutual desire to work together, patients and trial organizers often cannot find each other,” Lisa explains.

Some trials are stopped because they cannot enroll enough people and others are delayed because enrollment takes too long. In this unfortunate scenario – one that happens too often – this slows down the development of treatments and cures that patients depend on.

Lisa explains the importance of this search tool in providing a simple, fast way to discover trials specific to a disease, a location, and the personal characteristics of volunteers being sought.

“You can even opt in to be notified when more trials are posted, and send a message to the local trial site to request contact to learn more and possibly be screened for qualification purposes. “ Lisa explains. 

This free website can be found by anyone at centerwatch.com/clinical-trials.

Visitors to the site will find basic information about what a clinical trial is and why someone would want to participate.

Patient Advocacy groups are providing this website to their members to educate them about the value of clinical trials and where to find them, in order to support the search for cures. Patient groups like the Michael J. Fox Foundation for Parkinson’s Research, the Alzheimer’s Association, and the rare disease group The Rett Syndrome Foundation are enthusiastic about how their use of this tool is helping them help their communities of patients and their families. 

“Clinical trial search tools have been too complicated in the past and we sought to create a tool that is simple and fast so anyone can use it,”  Lisa explains. “Seeing the adoption by Patient Advocacy Groups is most satisfying.”

Lisa LaLuna of WCG Patient Advocacy has thirty years working in clinical trials and is a passionate advocate for easing the search for trials for those wishing to volunteer. 

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 Michael J. Fox Foundation for Parkinson’s Research is dedicated to finding a cure for Parkinson’s disease through an aggressively funded research agenda.

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.

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.

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.

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.

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.

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.