WCG Talks Trials

Listen to the latest episode of WCG Talks Trials to hear from experts on the importance of diversity, equity, and inclusion in clinical research and how intersectionality plays a role in promoting DE&I. We'll discuss why diversity is pivotal for comprehending the full spectrum of clinical care mechanisms and review effective DE&I strategies being deployed today. Discover how communities can be more actively engaged in clinical research and hear real-world examples of success stories in promoting diversity, equity, and inclusion within clinical research.

Moderator:

• Scott J. Hunter, PhD - Senior Scientific Expert, Neurodevelopmental and Rare Pediatric Diseases, WCG

Speakers:

• Sonya Dinizulu, PhD - Associate Professor of Psychiatry and Behavioral Neuroscience, University of Chicago 
• Desiree Underwood-Williams, PMP, CLSSBB – Director, Project Management Office, WCG 

Join WCG Talks Trials podcast host Kelly Fitzgerald, PhD, in a riveting dialogue with guest expert Currien MacDonald, MD, as they unravel the nuances of "Psychedelics in Research: Ethical and Medical Perspectives." 

Dr. MacDonald, with a solid foundation in family medicine and clinical trials administration, guides listeners through a grounded exploration of psychedelic substances. In this episode, they demystify the realm of psychedelics, encompassing both dissociative and classic varieties, such as LSD and MDMA. 

As the conversation delves into ongoing research, the potential applications of these compounds in treating mental health challenges like depression, anxiety, and post-traumatic stress disorder come to the fore. The dialogue doesn't shy away from probing the ethical dimensions surrounding psychedelic research, addressing concerns about study design, potential abuse, and the intricate balance between benefits and risks. This insightful podcast offers an engaging journey into the evolving field of psychedelic research, shedding light on its medical potential and the ethical considerations that guide its path.

In episode three of WCG Talks Trials, two WCG experts discuss key findings from the 2023 Avoca State of the Industry Report, which provides a 360-degree view on motivators and deterrents to clinical trial participation.

Listen in as we dive into feedback from perspectives across all clinical research stakeholders — sponsors, providers, sites, and patients — for valuable take-aways and insights into the trial experience.

Speakers:

Crissy MacDonald, PhD, Vice President, Client Delivery, WCG Avoca

Gina DiCindio, Associate Director, Industry and Client Research, WCG Avoca

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.