About this episode:

Listen to the latest episode of WCG Talks Trials to hear from experts on the importance of patient advocacy in clinical research and key takeaways from WCG’s 2023 Patient Forum. We’ll summarize how the patient forum elevates the voices of those changing drug development for the better and recap breakthroughs and best practices shared during the most recent event.

Discover more about patient and researcher collaboration, expanding diversity, equity, and inclusion in trials, and the latest advocacy-driven technology, science, and policy breakthroughs leading to modernized clinical research.  

Moderator & Speakers:

Desiree Underwood-Williams, PMP, CLSSBB

Director, Project Management Office, WCG

Steve Smith

President, Patient Advocacy, WCG

The post Amplifying Patient Voices to Advance Clinical Research: The Importance of Patient Advocacy appeared first on WCG.

About this episode:

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 & Speakers:

Scott J. Hunter, PhD

Senior Scientific Expert, Neurodevelopmental and Rare Pediatric Diseases, WCG

Sonya Dinizulu, PhD

Associate Professor of Psychiatry and Behavioral Neuroscience, University of Chicago

Desiree Underwood-Williams, PMP, CLSSBB

Director, Project Management Office, WCG

The post The Importance of Diversity, Equity, Inclusion, and Intersectionality in Clinical Research appeared first on WCG.

One finding was particularly interesting: Respondents who saw the pursuit of diversity as a scientific or ethical imperative felt more strongly about its importance than did those who considered diversity to be important primarily for regulatory or marketing reasons.

The scientific case for diversity is largely settled: What’s left is making the case. As one respondent said:

Moving decision makers away from a “check the box mentality” and ensuring they understand the scientific rationale for diversity could go a long way to improving the diversity of clinical trials in several ways:

• Generalizability: Not that long ago, researchers considered results from clinical trials to be largely generalizable to all patient populations. Growing evidence suggests this is not the case.^4,5 In fact, lack of representation in clinical trials compromises generalizability of research findings.⁶ Trials that include diverse populations, in contrast, help ensure that the findings apply to a broader range of patients.⁷

• Identifying subgroup effects: Without diverse representation, potential differences in treatment response among populations may go unnoticed. Testing a drug in a diverse sample allows researchers to understand these differences, and make informed decisions about dosages, safety, and effectiveness.⁸

• Health equity: More robust and complete data about differences in treatment response can ultimately reduce health disparities.⁹

Good science is good business

Including diverse participants in clinical trials not only aligns with scientific imperatives but also has significant business benefits. Sponsors gain valuable insights into product performance among different populations, informing marketing strategies and improving market penetration.

It can also reduce development costs by minimizing the need for additional studies or post-approval research, streamlining market entry and improving profitability. However, failure to include diverse populations can result in limited evidence for effectiveness or safety, leading to label restrictions and exclusion of patient groups, ultimately hurting market share and revenue potential.

Inclusive enrollment practices can increase patient interest and public confidence in new treatments—especially when patients know the clinical trial participants look like them.^10,11

Do you want help making the scientific case for DEI? Schedule a consultation with our experts today.

References:

1. FDA guidance “Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry”. November 2020
2. Clark LT, Watkins L, Piña IL, et al. Increasing Diversity in Clinical Trials: Overcoming Critical Barriers. Current Problems in Cardiology. 2019;44(5):148-172. doi:https://doi.org/10.1016/j.cpcardiol.2018.11.002
3. Calaprice, D, et al. Who Cares About Diversity in Clinical Trials? Journal for Clinical Studies. March 29, 2023. https://journalforclinicalstudies.com/who-cares-about-diversity-in-clinical-trials/
4. Sirugo G, Williams SM, Tishkoff SA. The missing diversity in human genetic studies. Cell. 2019;177(1):26–31. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7380073/
5. Bibbins-Domingo K, Helman A. (eds.) Why Diverse Representation in Clinical Research Matters and the Current State of Representation within the Clinical Research Ecosystem. National Academies Press (US); 2022. https://www.ncbi.nlm.nih.gov/books/NBK584396/
6. Bibbins-Domingo op. cit.
7. Clark LT, op cit.
8. Gross AS, Harry AC, Clifton CS, Della Pasqua O. Clinical trial diversity: An opportunity for improved insight into the determinants of variability in drug response. Br J Clin Pharmacol. 2022;88(6):2700-2717. doi:10.1111/bcp.15242
9. Clark LT, op.cit.
10. Enhancing clinical trial diversity. Deloitte Insights. November 2021 https://www2.deloitte.com/us/en/insights/industry/life-sciences/lack-of-diversity-clinical-trials.html
11. Schwartz AL, Alsan M, Morris AA, Halpern SD. Why Diverse Clinical Trial Participation Matters. New England Journal of Medicine. 2023;388(14):1252-1254. doi:https://doi.org/10.1056/nejmp2215609

The post The Scientific Rationale for Diversity in Clinical Trials appeared first on WCG.

Volume 15 Issue 1

Mar 30, 2023

The imperative to obtain a diverse body of clinical trial participants has been stressed in public statements for decades; however, parties executing clinical trials have remained insufficiently effective in addressing it. Understanding the patterns unveiled in this study’s analyses can inform policies and programs designed to effectively encourage personnel to make diversity-oriented decisions.

Authors

Denise Calaprice, PhD

Senior Consultant, WCG Avoca

Ryan Whitty

Research Assistant, University of California, Berkeley

Christina Moon

Clinical Research Associate, Brain Inflammation Collaborative, Inc.

Neva Hidajat

Clinical Research Intern, Brain Inflammation Collaborative, Inc.

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WCG assists sponsors in achieving an appropriately diverse and inclusive patient population in their clinical trials as a trusted partner to the life sciences industry. Request a consultation with our Diversity and Inclusion experts today:

contact us

The post Who Cares About Diversity in Clinical Trials? appeared first on WCG.

In December 2022, Congress passed the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act, which made diversity action plans mandatory. By December 2023, the FDA will issue guidance on the format and content of these plans.

“We don’t have to wait until then to understand what’s involved,” said Steve Smith, President, Patient Advocacy, WCG. “Many sponsors already have such plans in place, and those that don’t need to start,” he added.

Smith was one of three speakers in a recent WCG webinar titled, “Understanding the Evolving Multicultural Landscape and its Effect on Clinical Trial Participants.”

What’s in a Diversity Plan?

Citing legal experts¹, Smith outlined what sponsors should include:

1. Enrollment goals, disaggregated by age group, sex, and racial and ethnic characteristics;
2. The rationale behind these goals, including information about the condition and its prevalence and/or incidence among various demographic groups; and
3. How the sponsor will accomplish these goals, such as outreach and enrollment strategies, inclusion and exclusion practices, and diversity training for study personnel.

“The message from the FDA,” he says, is this: “Optimize data collection so all people can contribute.” Here’s what that looks like: ”

• Limit exclusion criteria: The FDA has acknowledged its past guidance may have led sponsors to go overboard on their inclusion/exclusion criteria. The agency is now trying to be more open and flexible, Smith said.
• Embrace digital health to identify participants based on demographics.
• Reduce burden on participants to improve access. A large part of that is incorporating elements of a decentralized clinical trial, such as remote technology and measurement.

The FDA is not only open to communicating with sponsors about diversity, they are eager, he reported. This represents a dramatic change, and sponsors should avail themselves of the opportunity.

Understanding Intersectionality

“As sponsors think about diversifying populations within clinical trials, they need a deep understanding of what diversification means,” said Scott J. Hunter, PhD, Senior Scientific Expert, Neurodevelopmental Disorders and Rare Pediatric Diseases, WCG.

The key to that understanding is a grasp of intersectionality. Intersectionality considers many aspects of a person’s identity, such as race, gender, sexuality, socioeconomic status, and disability, which influence their experiences and interactions with the world.

Understanding intersectionality helps us recognize how existing social structures of power and exclusion affect access to healthcare and to clinical trials, Hunter explains.

Historically, healthcare research has focused on privileged demographics, such as non-disabled white males. This has resulted in a limited understanding of the effectiveness and suitability of treatments for underrepresented populations. “Clinicians and researchers need to understand that the experiences of the prototypical white male do not encompass everything we need to know about health, disease and the experience of illness.”

So how do we engage diverse identities in clinical trials?

• Community roundtables involve meeting with key players in the community, including patients, caregivers, and community support members. “This allows us to discuss ways that we appreciate the barriers and the supports to recruitment, that we can then engage with and adjust.” It also cultivates cultural humility and helps everyone involved in clinical trials appreciate how their own biases may hinder recruitment success.
• Accessibility covers many elements, from language to how to address and support study demands. Such support includes mechanisms for better transportation, payment, engagement and communication.
• Data management includes thinking about the breadth of demographics rather than merely static identities like race or gender.
• Addressing stigma directly requires clinical trial stakeholders to examine their own biases and appreciate the experiences of others.

He also emphasized that decentralized trials will go a long way toward ensuring a study includes participants across racial, ethnic, socioeconomic, regional and other identities.

Pushing Past the Bias

The lack of diversity in clinical trials reflects a larger failure in the healthcare system as a whole. Loretta Veney — author, patient advocate and caregiver – A Black woman who shared her family’s experiences that vividly illustrate health system disparities.

In 1988, she began her journey, dealing with abdominal and pelvic pain, which her first gynecologist dismissed. After multiple hospitalizations, she was finally diagnosed with severe endometriosis. “That misdiagnosis by my first doctor resulted in 40 hospitalizations and 21 surgeries over a 13-year period. What a saga. That was absolutely a life-changing situation because I had only been married for two years, and then wasn’t able to have kids.”

Then 2006 brought what she calls the “trifecta.” Her aunt, Diane, was diagnosed with colon cancer; her sister, Renee, was diagnosed with multiple sclerosis; and her mother was diagnosed with dementia.

Diane had a deep mistrust of doctors because of Veney’s ordeal and ultimately died of colon cancer. “She would’ve never even considered a clinical trial as an option. I can even hear her voice: ‘I’m not going to be anybody’s guinea pig.’”

Renee, in contrast, was open to a clinical trial. Veney learned everything she could about MS and tried to connect her sister with a trial. “The only information we got was that clinical trials are usually for much younger people with MS.” Finally, someone promised to investigate whether there was anything for people with progressive MS. No one followed up. Renee died at 61.

Veney’s mother was diagnosed with dementia at 77. The neurologist never made eye contact with her mother. He simply said, “You’re in the beginning stages of dementia.” He didn’t give her time to gather herself; he just wrote a prescription. Her mother said she didn’t want to take the medication. The doctor’s response: “That’s what’s wrong with you people. You don’t want help; you just want to complain.”

Fortunately, her mother eventually  ended up with two wonderful doctors, and the “you people” comment led to coverage in Psychology Today.

Veney understands first hand why so many people are hesitant to take part in clinical trials. “Sometimes the things that we endure through our lives really set the stage for mistrust for years to come.” She’s working to overcome this mistrust. She encourages others to do the same by engaging with their communities and hosting forums to discuss health issues and clinical trials.

“I speak to African American groups about the benefits of clinical research,” she says. “I think there’s so much power in knowledge.”

References:

1. Hyman, Phelps, McNamara, FDA Law Blog

The post Diversity Action Plans Will Soon Be Mandatory for Clinical Trials appeared first on WCG.

Are caregivers considered research subjects? Their role in this study is limited to helping the study participant complete a symptom diary.

-Director, Clinical Operations, Pharma Company

Response:

Caregivers may offer support throughout a clinical trial by providing transportation to the research site, administering study medications, assisting the participant with diary entries or the completion of quality of life questionnaires, or observing and reporting clinical outcomes such as adverse events.

When the caregiver’s role is limited to facilitator, observer, or reporter, the caregiver is not considered a human subject as defined by the regulations and informed consent is not required.

Federal regulations (45 CFR 46.102e) define a human subject “a living individual about whom an investigator (whether professional or student) conducting research:

• Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
• Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimen.

However, the caregiver would be considered a research subject when a clinical trial is designed to collect data about the caregiver such as caregiver quality of life or the physical or emotional burden of caregiving tasks. For example, some Alzheimer’s Disease clinical trials have adopted caregiver outcomes as secondary endpoints. 

Even when the caregiver is not a research subject and informed consent is not a regulatory requirement, you may want to consider providing the caregiver with educational materials such as an information sheet that clearly outlines their role and responsibilities. 

The post Caregivers as Research Participants appeared first on WCG.

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About this Episode

In this episode we speak with Pam Mace, Patient, Executive Director and Co-founder of the Fibromuscular Dysplasia Society of America.

Without a cure, this patient advocate collaborated with researchers from Mt. Sinai, and the Victor Chang Cardiac Research Institute and catalyzed a growing patient advocacy movement that drives information exchange, physician education, and data collection.

The post Fibromuscular Dysplasia Society of America: Collaboration Between Patients, Researchers, and Physicians Saves Lives appeared first on WCG.

About Dr. Reynold Verret

Dr. Reynold Verret is the president of Xavier University of Louisiana, one of the Historical Black Colleges and Universities. He speaks here about mentoring and educating the next generation of health care and clinical research professionals from minority communities. Xavier University has a long history of transforming the lives of those from underserved communities to prepare them to make major contributions to society through leadership in a variety of professions.

Dr. Verret received his undergraduate degree cum laude in biochemistry from Columbia University and a Ph.D. in biochemistry from the Massachusetts Institute of Technology in the laboratory of the late Har Gobind Khorana. Beyond his degrees, he has postdoctoral experiences as a fellow at the Howard Hughes Institute for Immunology at Yale and the Center for Cancer Research at MIT where he completed research regarding immunology.

The post Preparing the Next Generation of Minority Students for Careers in Clinical Research and Medicine appeared first on WCG.

The post Patient Advocacy Groups in Action: A Panel Discussion appeared first on WCG.