By Felicia Irvin, VP of Business Development at M3 Wake Research
The Evolving Landscape of Clinical Trials
The world of clinical trials is changing rapidly, shaped by breakthroughs in medical science and a growing demand for better, more accessible treatments. Clinical trials are at the heart of medical progress: they are the process by which new medicines, vaccines, and therapies are evaluated for safety and efficacy before reaching the wider community. Yet, despite their importance, many clinical trials still struggle with limited participation and a lack of representation from diverse patient populations.
One of the biggest challenges is making sure that clinical research studies truly reflect the communities they aim to serve. Traditional models often overlook patients who don’t live near major research centers or who face barriers related to time, language, or trust. That’s where community physicians come in. These trusted healthcare providers are uniquely positioned to identify potential participants, address concerns, and guide patients through the clinical trial process.
Modern strategies, like using targeted search terms in online databases, make it easier than ever to find relevant clinical trials and connect patients with opportunities that match their health needs. By enhancing trial design, increasing awareness, and focusing on access in community settings, we can accelerate the development of new treatments and improve overall health outcomes for everyone. Community physicians are at the forefront of this evolution, helping to ensure that clinical trials are safer, more effective, and more inclusive than ever before.
Personal Perspective on Building Trust, Access, and a Better Trial Model
At M3 Wake Research, clinical trials are not just a system — we see them as a promise to patients. A promise that healthcare innovation should be for everyone, not just those who happen to live near a hospital system or have the time and means to participate.
As a clinical leader at M3 Wake Research, I’ve spent years seeing what works—and what still holds people back. We’ve talked a lot in this industry about diversity in trials. But what I’ve learned is this:
Clinical research doesn’t have a diversity problem. It has an access problem.
Access isn’t just about geography — it’s about trust, culture, time, language, life, and the many factors that influence participation. Factors such as race, age, and specific eligibility criteria can significantly impact who is able to participate in clinical research. Patients who are interested in joining research studies may still face barriers related to these factors. When designing inclusive research models, it is important to consider participant interest and address these barriers. Building trust also requires ongoing education to increase awareness and engagement among diverse communities.
Bringing Research to the People Who Need It Most
Our mission is simple: if we want research to reflect the real world, then we have to go where the real world lives. That’s why we’re partnering with community physicians — the doctors patients already know, trust, and rely on — to embed clinical trials directly into everyday care at local facilities, allowing patients to be treated in familiar settings. Community physicians play a crucial role in maintaining control over patient care and access to research opportunities.
This model was developed to enhance access and inclusivity, ensuring that more patients can participate in clinical research. As part of comprehensive patient care, providing food and nutritional support is also essential to improve health outcomes and engagement.
When we move research closer to home, especially in key areas like oncology and cancer, it becomes:
- More human
- More attainable
- More equitable
Trust Begins in the Exam Room
As a clinical leader, I know the kind of trust that exists between a patient and their primary care provider. It’s built over years, sometimes decades. That relationship is deeply personal.
Investigators and physicians often work together to provide education about research opportunities, helping patients understand the potential benefits and risks. This education is essential for building trust and facilitating participation in clinical studies.
So when that provider mentions a research opportunity, it doesn’t feel like a pitch. It feels like care.
It feels like:
- “I thought of you.”
- “This might help.”
- “Let’s explore this together.”
When patients show interest and are interested in learning more, they are more likely to engage in research and consider participation.
We’re leaning into that trust. We’re not replacing the physician-patient relationship—we’re honoring it and building research around it.
Reaching Those Who’ve Been Left Out
Too often, we talk about “hard-to-reach populations” as if they’re unwilling. But they’re not hard to reach — they’re just rarely invited in ways that feel safe, convenient, or relevant.
Definitions of minority groups and outreach strategies may vary between countries, as each country’s societal context and internationally accepted standards influence how minority status is classified and addressed.
When designing inclusive research models, it is important to consider race and other eligibility criteria to ensure participant suitability, study integrity, and diversity. Ongoing review and assessment of outreach efforts are essential to evaluate progress and identify areas for improvement. Funding is crucial to support diversity and inclusion initiatives, ensuring that resources are available for staff, outreach, and program development.
That’s changing. With this new model, we’re:
- Going into rural communities
- Hiring and training multilingual staff
- Setting evening and weekend hours
- Using patient-first technology that supports them—not just sponsor dashboards
- Developing strategies tailored to different populations to address disparities and improve representation
This isn’t about checking boxes. This is about righting systemic wrongs and making sure our trials finally reflect the beautiful complexity of the communities we serve.
Empowering Physicians, Not Overloading Them
We’ve also heard from countless community doctors who’ve said, “I want to be part of research, but I don’t have the time or staff.” That’s where we come in.
Ongoing education and training for staff involved in clinical research is essential to maintain high standards and ensure quality outcomes. Our facilities play a crucial role in supporting both research and patient care, providing the environment and resources needed for success. We use well-defined criteria to select eligible participants for clinical trials, ensuring study integrity and diversity. Evidence-based practices are at the core of our approach, supporting physician participation and improving patient outcomes.
M3 Wake Research gives these physicians everything they need to succeed, including:
- Experienced research coordinators
- Regulatory support and sponsor connections
- Seamless systems that fit into their existing workflows and enhance the effectiveness and accessibility of research programs
We make it possible for them to offer cutting-edge options to their patients without disrupting the care they already provide.
Resources for Successful Partnerships
Building strong partnerships between researchers, community physicians, and patients is essential for the success of clinical trials. Fortunately, there are a wealth of resources available to support these collaborations and ensure that clinical research is conducted safely and effectively.
Online databases like clinicaltrials.gov are invaluable tools for both physicians and patients. These platforms allow users to search for clinical trials by disease, condition, or location, making it easier to find studies that are relevant to their needs. By using specific search terms, community physicians can quickly identify opportunities for their patients to participate in cutting-edge research.
Organizations, like M3 Wake Research, dedicated to clinical research play a crucial role. We offer guidance on trial design, participant recruitment, and data safety, helping to ensure that every clinical trial meets the highest standards of quality and regulatory compliance.
Public health initiatives further support these efforts by raising awareness about the importance of clinical trials and encouraging healthy volunteers from all backgrounds to participate. This not only increases diversity among trial participants but also helps ensure that new treatments are safe and effective for people of all ages, races, and communities.
By leveraging these resources, community physicians and researchers can work together to create clinical trials that are more accessible, more inclusive, and ultimately more successful in improving health outcomes for everyone.
This Is Personal. And It’s Just the Beginning.
For me — and for so many others at M3 Wake Research — this work is deeply personal.
It’s about:
- The grandmother who never had access to care but might now contribute to research that helps her grandkids be treated with new medicines and treatments developed through clinical research.
- The mom balancing three jobs who can finally join a study because her doctor’s office extended hours, opening new opportunities developed to improve care and access to treatment.
- The patient who didn’t speak English but got the information in their language and said yes, becoming part of the process of identifying new treatment options for patients facing illness.
Those stories remind us why we do this and highlight the impact of research on preventing and managing illness.
Final Words from Leadership
We’re not just reimagining clinical trials. We’re rebuilding the foundation — one that centers people, not processes.
Our ongoing focus is on inclusivity and accessibility in clinical research, ensuring that every trial reflects the diversity of the communities we serve. We are committed to enhance the effectiveness and reach of clinical trials, making them more accessible and impactful for all participants. We continually develop new strategies and models to advance research, including targeted therapies and innovative diversity plans. Regular review and assessment of our programs are essential to ensure continued progress and improvement.
Partnering with community physicians is more than strategy. It’s compassion in action. It’s our commitment to create trials that are truly inclusive, truly accessible, and deeply human.
If you’re a physician who wants to bring research into your practice or a sponsor seeking a more representative study model — we’re here.
