January 31, 2024

Enhancing Cardiovascular Research: Profound’s Collaborative Approach with MHP CAVA

Clinical research plays a crucial role in advancing medical knowledge, with sponsors and contract research organizations frequently facing the challenges posed by the intricacies of cardiovascular studies. One prevalent challenge is the limited availability of US-based sites, prompting sponsors to seek new, community-based alternatives. Profound Research empathizes with these challenges and has developed a thoughtful approach to simplify a comprehensive range of clinical studies, including cardiovascular.

Understanding Sponsor Challenges:

Sponsors navigating the intricate landscape of cardiovascular research often encounter hurdles due to a restricted US-based site footprint. This saturation poses challenges in conducting studies efficiently and reaching diverse patient populations. Profound Research acknowledges this dilemma and has tailored its model to provide sponsors with a solution that overcomes typical challenges and aligns with their goals.

The Key Solutions: Community-based Partnerships and Central Support

To solve these challenges in the cardiovascular space, Profound Research, whose network also includes MHP TriaAtria and Southern California Heart Specialists, has formed a partnership with Michigan Healthcare Professionals Cardiology and Vascular Associates (MHP CAVA). Situated at 42557 Woodward Avenue, Suite 200, Bloomfield Hills, MI 48304, MHP CAVA serves a diverse range of populations just 30 minutes outside of Detroit.

One: Leadership at MHP CAVA

At the forefront of this collaborative effort are two highly experienced interventional cardiologists: Abdul R. Halabi, M.D., FACC and Kirit Patel, M.D., FACC. With a collective experience exceeding fifty years, these providers have dedicated themselves to advancing cardiovascular medicine and have played pivotal roles as principal or sub-investigators in over seventy research studies. Their commitment to patient well-being and innovation aligns seamlessly with Profound's mission of actively connecting patients to advanced therapeutic options in their own communities.

Two: Profound's Comprehensive, Centralized Support

Beyond establishing strategic relationships and connecting sponsors with community-based providers, Profound Research offers central support to sponsors, covering crucial aspects such as technology, feasibility, budget and contract, regulatory and startup processes, as well as quality control. This centralized support ensures that sponsors can concentrate on the scientific aspects of their studies while Profound handles the logistical and administrative challenges, resulting in expedited progress and truncated timelines from start-up on through the fruition of clinical advancements. To learn more about Profound's approach to centralized support, click here.

Taking Action: How Sponsors Can Benefit

To get started, Profound Research invites sponsors to include any one of our four cardiovascular research sites in ongoing and planned feasibility processes for cardiovascular studies. By doing so, sponsors will access a largely untapped patient population along with the expertise of our highly skilled team at MHP CAVA. We look forward to discussing with innovators in the cardiovascular space how Profound’s cardiovascular sites can tailor support to specific research needs.

Conclusion

In cardiovascular research, Profound Research emerges as a preferred collaborative partner, offering thoughtful solutions to sponsors seeking efficient and impactful studies. The partnership with MHP CAVA, coupled with Profound's comprehensive support, creates an inviting opportunity for sponsors to advance their research goals seamlessly. By engaging with Profound's feasibility team at feasibility@profoundresearch.io, sponsors can take the first step toward transforming their cardiovascular research initiatives.

January 4, 2024

Bridging the Gap: How Profound is Harnessing the Power of Diversity for Robust Clinical Trial Outcomes

Byline: Erem Latif

Over the past 12 years, there has been a growing emphasis on exploring the social determinants of health. Our comprehension of how economic stability, community dynamics, access to resources, and the quality of education, among various other nuanced elements, significantly influence an individual's health, quality of life, and overall outcomes has substantially expanded. The U.S. Office of Disease Prevention and Health Promotion has even launched the Healthy People 2030 plan to help address the upstream factors impacting health disparities.

Futhermore, personalized medicine, the understanding that variables like genetics, environment, and lifestyle play a direct role in shaping an individual's response to identical treatment regimens or vaccines, is leading to an evolution in healthcare. Ultimately, each person's unique lived experience, impacted by environment, ethnicity, age, gender, and other societal factors becomes the foundation for their physical and mental well-being.

The Crucial Role of Diversity in Patient Recruitment for Clinical Research Studies

When applied to clinical research, the recognition of social determinants of health amplifies their impact on diverse lived experiences. The imperative arises for our society to ensure the effectiveness of new treatments across all population subgroups. However, recent data reveals a predominant participation of white individuals in clinical research endeavors.

References:

- US Food and Drug Administration 2020 drug trials snapshot. Summary report.

https://www.fda.gov/media/145718/download

- US Food and Drug Administration. Enhancing the diversity of clinical trial populations—eligibility criteria, enrollment practices, and trial designs guidance for industry.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial

Advancements in healthcare underscore the variability in how individuals experience the same disease, with certain medications exhibiting distinct efficacy across diverse populations, ages, or genders. It is crucial that safety and efficacy data from clinical research encompass the experiences of all subgroups before treatments receive approval and enter the market. The dearth of diversity in clinical research poses the risk of rendering medications and treatments less effective for specific subgroups.

A notable illustration of this discrepancy is evident in the varying efficacy of beta blockers and ACE inhibitors between individuals of White European and Black African ancestry.

Reference:

https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.107.704023?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed

More recently, during the Covid-19 pandemic, preliminary findings from the trial of Moderna’s Covid-19 vaccine were based on a predominantly White participant population—not an adequately representative sample of the U.S. population.

Defining Diversity in Patient Recruitment for Clinical Trials: Profound Research's Perspective

Examining Profound Research's approach to defining diversity involves delving into the specific criteria and considerations we employ. Our definition encompasses factors such as age, gender, ethnicity, socioeconomic status, and other relevant parameters. We adhere to validated (?) guidance from esteemed sources like the NIH and the FDA, utilizing a comprehensive framework that goes beyond conventional criteria. This includes incorporating nuanced parameters that profoundly impact the lived experience of individuals. Our commitment extends further to considering typically underrepresented therapeutic areas or conditions and addressing data gaps across various subpopulations.

References:

https://www.nimhd.nih.gov/resources/understanding-health-disparities/diversity-and-inclusion-in-clinical-trials.html

https://www.fda.gov/consumers/minority-health-and-health-equity/clinical-trial-diversity

Strategies Employed by Profound Research to Enhance Diversity in Patient Recruitment Across Demographic Groups

Profound Research is committed to revealing the proactive measures and approaches undertaken to actively recruit and engage diverse patient populations, with the ultimate goal of ensuring a representative sample in clinical studies.

Our approach is multifaceted, commencing with a focus on geography. We strategically establish partnerships with sites in urban and metro areas. Building upon this foundation, we delineate geographic regions, positioning our sites as central hubs. Recognizing that potential participants prefer local accessibility, we aim to minimize travel distances for involvement in clinical trials or physician visits. Additionally, we actively immerse ourselves in these communities, participating in health fairs and providing screenings and related services. Through the dissemination of information and resources, our objective is to empower local patients, fostering a basis of trust within these communities. We envision the cultivation of this trust as a standard practice, allowing us to recruit patients from diverse backgrounds effectively.

Significance of Geographic Diversity in Patient Recruitment

Centrally addressing the importance of geographic diversity, this discussion emphasizes its pivotal role in advancing the overarching diversity objectives within clinical research studies. The exploration extends to encompass regional health variations, cultural distinctions, and the profound impact of local demographics on the outcomes of the studies.

Furthermore, the positioning of research sites in diverse regional hubs such as San Diego, Los Angeles, and Detroit, paired with diversity of staffing directly contribute to enhancing trial diversity. Recent findings from a white paper by Tufts Center for the Study of Drug Development underscore a significant correlation between the diversity of research site staff and the diversity observed among patients involved in clinical trials.

References: https://medicine.tufts.edu/news-events/news/increase-diversity-clinical-trials-first-increase-staff-diversity

In light of this insight, Profound Research strategically chooses urban areas characterized by vibrant and diverse populations. By establishing partnerships with sites committed to effective practices for engaging and enrolling diverse patients—bolstered by robust infrastructure and streamlined processes—the company is actively contributing to the delivery of expanded treatment options to those who need them most.

Strategies in Overcoming Diversity Challenges for Credible and Relevant Study Findings

Overcoming the primary challenge of recruiting diverse patient populations, particularly centered around trust, is a focal point for Profound Research. Over the years, a pervasive lack of trust has been observed among minority patients within the healthcare system, with historical incidents such as the syphilis research conducted by the U.S. Public Health Service at the Tuskegee Institute of Alabama exemplifying this issue. Language poses a secondary barrier, underscoring the importance of effective communication tailored to patients' comprehension levels regarding potential treatment benefits, possible side effects, and the significance of adherence to treatment regimens. Additionally, logistical hurdles like transportation, employment commitments, and childcare responsibilities can hinder participation.

To address these challenges comprehensively, Profound Research offers external support mechanisms to its research sites, allowing them to concentrate on patient care. Community events held at centers, religious organizations, and farmers markets play a crucial role in building and fostering a relationship of trust with diverse populations. The organization's dedicated team of patient engagement specialists consistently provides education and information to local patient communities, addressing disparities arising from limited access to education. Moreover, Profound has developed concierge-style patient support services, aiding with transportation, childcare, and other potential impediments that might otherwise deter diverse populations from participating in clinical trials.

Conclusion

At its core, individual health is shaped by the intertwined dynamics of physical and mental well-being, profoundly influenced by the lived experience and social determinants of health. Profound Research, by prioritizing diversity and ensuring access to treatment options for all, and through strategic partnerships with like-minded practices, is actively transforming the landscape of clinical research. This commitment aligns with the understanding that addressing diversity challenges and fostering inclusivity not only enhances the credibility and relevance of study findings but also contributes to a more comprehensive and equitable healthcare future.

About the Author: Currently serving as the Senior Director of Patient Recruitment and Engagement for Profound Research, Erem Latif, MS, MBA, is an innovative healthcare leader with experience in leveraging operational excellence, client relationship management and strategic marketing and communications to elevate brand, drive patient engagement, and optimize clinical outcomes. Furthermore, Erem offers a deep understanding of complex industry and proven methodologies to improve results for providers, health systems, and payers.

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