A Patients Perspective of Clinical Trial Benefits

Dorothy Leone-Glasser, RN, HHC, CEO Advocates for Responsible Care,

Chair Ga Bio Patient Advocacy Alliance

Clinical trials are essential for the development of new treatments for chronic illness patients. Every new medicine and treatment started with volunteers participating in clinical trials. Our current high standards of medical care and newly discovered therapies have improved the lives of so many patients with chronic, incurable illness. In addition to testing new drugs and devices, clinical trials provide a scientific basis for advising and treating patients.

Being diagnosed with an incurable disease at 19 years, I have always participated in clinical trials. Yes, the larger view of clinical trials research is designed to yield scientific knowledge for future patients that improves their health outcome. For me, the decision to take part in trials was a necessity to stay alive. Having serious complications to my Systemic Lupus, medicine was still in the dark as to effective treatment to stop the progression of the disease.  I was involved in clinical trials from Plasmapheresis, nutrition and lifestyle changes to drugs used for other diseases.  When I was an adult, needing to obtain my own medical insurance, prior to the ACA, I was unable to get insured because of my poor risk rating due to heart attack, stroke, kidney failure and seizures; all related to my disease. With my next diagnosis of cancer at age 30 then another cancer diagnosis five years later, I was once again looking for clinical trials. I was fortunate to know caring physician colleagues who assisted me in my quest. Physicians play a key role in referrals to clinical trials. Being well-prepared to answer common questions will help clinicians guide their patients and family members through the decision process.

I did my research to understand the risks and benefits of each trial, knowing that rules are in place to protect human research subjects and all studies involving humans are reviewed locally to ensure that subjects are treated safely, fairly, and confidentially. Nevertheless, each patient should consider for themselves whether participation in a trial is safe for them and consistent with their values. Every patient must be comfortable to ask the research team any questions they have and to voice their concerns throughout the trial period. Patients must understand that there are risks in clinical trials, such as possible side effects resulting from the treatment and they should be aware that the treatment may not be effective for the participant. Participating in a trial also takes a greater commitment of your time and attention than standard treatment.

The accepted view had been, patients should not misunderstand clinical trials as a substitute for medical care. However, without insurance, I saw the clinical trial as a way to obtain expert medical care at a leading health care institution. The rigorous oversight during the trials helped to empower me to be my best healthcare advocate, keep me on track with my self-care and opened the door to other resources that enabled me to continue my education and career goals even while wheelchair bound.

Clinical trials provide research that helps patients be full participants in their illness, regardless of the trial outcome. Well-designed and executed clinical trials provide an opportunity for participants to:

  • Play an active role in their own health care
  • Empower patients to be their best healthcare advocate
  • Gain access to new research treatments before they are widely available
  • Increase the options for treatment when standard therapy has failed
  • Obtain expert medical care at leading health care facilities during the trial
  • Expand research and methods of care to underserved and minority communities while balancing health equity
  • Help others by contributing to the advancement of medical knowledge

Participating in clinical trials throughout my illness journey has extended my life, empowering me to have a successful career as a Nurse Specialist, Chronic Illness Counselor and Health Advocacy organizer. They provided an opportunity to understand the complexities of my diseases, to have my voice heard as an involved patient, to ease the stress for my concerned caregivers and to play a role in helping other patients sharing the same illness struggles.

Clinical trials are essential for the development of new treatments. Whether or not to participate in a clinical trial is a personal decision. Each patient and each clinical trial is different. When considering a clinical trial, you must commit to being an active participant; gathering as much information as possible, coordinating with your physician and medical team and then doing what you feel is best for you. Those who decide to volunteer may be contributing directly to our understanding of diseases and how to treat them.

Panelists

Michelle Kimberly Clark headshot

Michelle Kimberly Clark

Breast Cancer Survivor, Clinical Trials Patient Participant

In May of 2013, while exercising Michelle felt a small mass on her left breast. In 2015, she met Andre (her husband), starting her life as a young, vibrant, African American woman. They moved to Atlanta and as Michelle states, she was “on her way to living every girl’s dream of love, marriage, and then the baby in the baby carriage!” While showering she noticed that after two years the lump was still in her breast. She scheduled her annual physical, and unfortunately was told by her doctor not to worry about the lump; “You’re too young,” the doctor exclaimed! 

In 2019 Michelle sought a second opinion by a new doctor who scheduled her for a mammogram and ultrasound. The COVID-19 pandemic hit and stalled her appointment for what has already been a long and unsettling process. In August 31, 2021, after completing a mammogram and ultrasound., at just 36 years old, Michelle was diagnosed with breast cancer in her left breast with a suspicious area on her right breast.

Michelle made the difficult decision to have double mastectomy surgery. On November 2, 2021, she froze seven (7) embryos and on January 2022 she entered a clinical trial, completing four rounds of intense chemotherapy. A component of her trial included the research team tracking neuropathy in African American women under treatment using the drug Taxane (docetaxel).

Michelle admits she was hesitant to participate in the clinical trial at first, because of the uncertainty and having a bit of selfishness for her own health. However, after voicing her concerns to her doctor and an amazing research nurse, she felt comfortable with being a part of a clinical trial that would allow her to discuss the effects of the treatment.  Oftentimes, patients dealing with serious illness hear the words “clinical trial” and they feel reluctant to move forward. Michelle felt reassured this trial allowed her to feel confident in knowing that her experience would benefit more black women undergoing treatment for breast cancer in the future. From her participation in this trial, her research nurse, later became a part of her support group.  Michelle believes that clinical trials are important because they allow medications and treatments to be effectively targeted for African American women.

Dr. Del Smith headshot

Dr. Del Smith

CEO, Acclinate

Dr. Del Smith is passionate about using business principles to address health inequities that have long plagued communities of color. He is the co-founder and CEO of Acclinate, a growing digital health company on a mission to improve health equity through inclusive research. Del’s career spans healthcare, IT, government, and higher education. He earned his Ph.D. In Management from the University of Alabama and spent seven years as an HBCU business school dean prior to co-founding Acclinate.   

Jessica Williams headshot

Jessica Williams, MD, MPH

Assistant Professor of Medicine; Division of Rheumatology; Emory University School of Medicine; Director, Lupus Patient Navigator Program Grady Lupus Clinic

Jessica Williams, M.D, M.P.H is an Assistant Professor of Medicine in the Division of Rheumatology at Emory University School of Medicine. Dr. Williams is a graduate of Emory University School of Medicine (MD, 2015), Emory University Rollins School of Public Health (MPH in Epidemiology, 2015), Harvard/Brigham and Women’s Hospital Internal Medicine Residency (2018), and Harvard/Brigham and Women’s Hospital Rheumatology Fellowship (2021). She is passionate about clinical research to advance care for patients living with lupus, with a focus on diverse and underserved patient populations. Her research to date has resulted in twenty-four publications and two oral presentations at the American College of Rheumatology annual meetings. Her recent first-author publications have focused on increasing diversity in lupus clinical trials, racial disparities in contraception care among reproductive age-women with lupus, and use of an integrated care management program to uncover social determinants of health needs among patients with lupus. Dr. Williams is also a practicing rheumatologist at Grady Memorial Hospital in Atlanta, Georgia, where she supervises Emory rheumatology fellows in both the clinic and inpatient consult setting.

Dr. Williams was recently awarded a grant from the Bristol Myers Squibb Foundation Diversity in Clinical Trials Career Development Program to study clinical trial perceptions and barriers among a large, population-based, predominantly Black cohort of patients with lupus and to implement the Phase III REGENCY clinical trial for lupus nephritis in a predominantly Black, safety-net clinic setting. She has also received research awards from the Rheumatology Research Foundation and the American Society of Hematology, as well as a Health Equity Innovation Program research grant from the Brigham and Women’s Hospital Department of Medicine to implement a nurse-led pilot clinical trial to reduce acute care utilization and improve preventive care among high-risk patients with lupus. Her other current projects include implementation of a lupus patient navigator program in the Grady Lupus Clinic, development of a lupus cohort in rural Georgia, exploring risk factors for suicidality among patients with lupus, and exploring social determinant of health risk factors for recurrent acute care use among patients with lupus.

Georgia's Political Landscape Has Changed. Our Mission Hasn't.

November 4, 2026
CEO Note: A New Political Landscape, A Continued Commitment to Georgia Life Sciences Georgia's 2026 election results mark a historic shift in the state's political landscape, setting the stage for a new administration, new statewide leadership, and a potentially changed balance of power in the General Assembly as we approach the 2027 legislative session. At the national level, Democrats won control of both chambers of Congress , creating a new dynamic for federal policymaking. With the presidency remaining under Republican leadership, the coming years will require bipartisan cooperation to advance legislation. Changes in congressional leadership and committee oversight could significantly affect healthcare, federal research funding, FDA policy, drug pricing, and patient access. The most significant changes for our industry, however, are happening here in Georgia. Keisha Lance Bottoms' victory in the gubernatorial race marks a historic transition in state leadership, ending more than two decades of Republican control of the Governor's Office. She will also become the first Black woman elected governor in U.S. history. Democrats also swept Georgia's statewide executive offices , including lieutenant governor, attorney general, secretary of state, and the commissioners responsible for agriculture, labor, and insurance. These leadership changes create new opportunities for engagement on the policies and investments that shape Georgia's economy. In the General Assembly, Democrats made substantial gains and appear positioned to take control of the Georgia House of Representatives , pending final results in several close races. Republicans retained a narrowed majority in the State Senate. This potentially divided legislative environment will require thoughtful engagement and collaboration across party lines. We can also expect considerable turnover in the General Assembly, with dozens of new legislators beginning their terms in January. Along with a new Governor and incoming administration, this creates an important opportunity to introduce policymakers to Georgia's life sciences industry, its economic contributions, and its potential for future growth. What Does This Mean for Georgia's Life Sciences Industry? Life sciences is an economic development priority that should transcend party lines. Our industry's growth depends on a combination of sound public policy, private investment, research, workforce development, infrastructure, and a business environment that encourages innovation and commercialization. As Georgia establishes its new leadership priorities, several areas will be particularly important: Economic Development and Manufacturing: Positioning Georgia to attract and retain biopharmaceutical, biotechnology, and MedTech companies while advancing the infrastructure and capabilities needed to support scale-up manufacturing. Research and Commercialization: Strengthening connections between Georgia's research institutions, emerging companies, investors, and industry partners to move discoveries from the laboratory into commercial applications. Workforce Development: Expanding investment in technical education, apprenticeships, and industry-aligned training to prepare Georgians for the growing range of life sciences careers. Capital and Investment: Improving access to capital and supporting programs that help Georgia-based companies grow, commercialize technologies, and remain competitive. Healthcare Innovation and Patient Access: Supporting an environment that encourages medical innovation, advances research, and improves patient access to new treatments and technologies. These priorities align directly with Pathways & Partnerships: A Roadmap for Georgia's Life Sciences Sector , our ten-year strategy to position Georgia as a leading scale-up manufacturing hub in the Southeast. Georgia enters this transition with both an opportunity and a clear need to strengthen its competitiveness in life sciences. The recently released BIO/TEConomy report highlights the industry's significant contributions, including more than 42,600 jobs across over 4,200 establishments, while reinforcing the opportunity for Georgia to accelerate growth relative to other states. Our Roadmap provides a foundation for working with policymakers to turn these opportunities into sustained investment, stronger industry partnerships, and high-quality jobs throughout Georgia. GLS's Role Moving Forward For Georgia Life Sciences, this transition reinforces the importance of our role as the industry's statewide voice and convener. We will be intentional about building relationships with the incoming administration, new legislative leadership, returning legislators, and state agencies. We must ensure that policymakers understand not only the healthcare implications of our industry, but also its broader economic impact: high-quality jobs, significant research investment, advanced manufacturing, innovation, and opportunities for communities across Georgia. At the federal level, we will continue working with our national partners and Georgia's congressional delegation to advocate for policies that sustain research and innovation, support a predictable regulatory environment, strengthen American biomanufacturing, and advance patient access. With a new administration and many new legislators, we have an opportunity to establish a stronger understanding of what it takes to build and sustain a competitive life sciences ecosystem. That means bringing industry leaders to the table, communicating our priorities, identifying areas of bipartisan alignment, and advocating for policies that support long-term growth. Our industry's success requires a long-term commitment that extends beyond any election cycle or administration. The political landscape may change, but our commitment to advancing Georgia's life sciences industry remains constant. We look forward to working with leaders on both sides of the aisle to ensure Georgia continues to be a place where life sciences companies can innovate, invest, manufacture, and grow.

Why PDUFA Reauthorization Matters for Georgia’s Patients and Economy

October 30, 2026
For Georgians living with serious and rare diseases, how quickly and predictably a new treatment moves through U.S. Food and Drug Administration (FDA) review can make a real difference. That predictability also matters to the researchers and businesses that make up Georgia’s growing life sciences sector. Both depend in large part on the Prescription Drug User Fee Act (PDUFA), a longstanding bipartisan program that Congress needs to reauthorize by 2027. How PDUFA Works Since 1992, PDUFA has allowed the FDA to collect user fees from biopharmaceutical companies to supplement the agency’s resources for reviewing new medicines. In exchange, the FDA commits to clear, predictable review timelines. The agency’s standards for safety and efficacy remain unchanged. By providing additional resources and establishing clear performance goals, PDUFA helps ensure patients can access new treatments in a more timely and predictable manner. The result of PDUFA have been significant. Before PDUFA, FDA reviews often took more than two years. Today, the median review time is 10 months for standard applications and 8 months for priority applications. In 2025, nearly 70% of new medicines were approved in the U.S. before any other country. What’s at Stake in 2027 Congress reauthorizes PDUFA every five years. The current agreement, PDUFA VII, expires September 30, 2027. Timely reauthorization is critical to maintaining the FDA’s review capacity, preserving regulatory predictability, and ensuring patients continue to benefit from medical innovation. Georgia stakeholders recently came together to talk through what that means here at home. On October 28, Georgia Life Sciences, the MTS Sickle Cell Foundation, and Georgia First hosted “PDUFA: How Medicines Reach People,” a lunch-and-learn at Brookhaven City Centre. Patient advocates, congressional staff, and business and academic leaders heard from Nick Magallanes of Todd Strategy Group, Natalie Crawford of Georgia First, Maria Thacker-Goethe of Georgia Life Sciences, and Mapillar Dahn of the MTS Sickle Cell Foundation. What We Heard At the event, speakers came at PDUFA from different angles, but the common thread was how the program affects Georgians. Mapillar Dahn of the MTS Sickle Cell Foundation stressed that patients need to remain at the center of conversations. As a mother of three daughters with Sickle Cell Disease, Mapillar stressed that she wants the FDA to have what it needs to carry out a thorough review without unnecessary delays. The confidence families place in a treatment depends in part on confidence in that process. Natalie Crawford with Georgia First and Mended Hearts spoke about the need for a fully resourced FDA so that Georgia patients have access to innovative treatments and also for a healthy Georgia economy. Additionally, Maria Thacker-Goethe spoke to what PDUFA reauthorization means for Georgia’s booming life sciences sector. She warned that without PDUFA reauthorization, research across the board will be stifled – ranging from devastating impacts to small startups to significant delays in investments and research. Part of a National Conversation As Congress prepares for the 2027 reauthorization, conversations like these help bring together patients, advocates, and community leaders to highlight the real-world importance of the program. Decisions made in this reauthorization cycle will shape FDA resources and review timelines nationwide. By reauthorizing PDUFA on time, Congress can make sure the FDA can keep reviewing new medicines efficiently and patients in Georgia and across the country can get the treatments they need. 

Georgia’s MedTech Momentum: Building on Growth and Strengthening Our Innovation Ecosystem

October 29, 2026
New Hypepotamus feature explores Georgia’s growing MedTech sector and opportunities to strengthen startup development, commercialization, and long-term industry growth Georgia’s life sciences industry is experiencing significant growth, fueled by major investments, expanding research capabilities, and an increasingly connected innovation ecosystem. From biotechnology and medical devices to diagnostics and digital health, the state continues to demonstrate its potential as a destination for life sciences innovation. As Georgia builds on that momentum, an important opportunity is emerging: ensuring that the startups and technologies developed here have the resources and support to grow, scale, and remain in the state. A new Hypepotamus feature, “Atlanta’s MedTech Momentum Faces a Test: Can Startups Stay and Scale?” , by Maija Ehlinger, explores this next phase of ecosystem development. Featuring perspectives from entrepreneurs, investors, and industry leaders, including Georgia Life Sciences President & CEO Maria Thacker Goethe, the article examines how Georgia can build on its existing strengths while addressing challenges facing emerging companies. A Strong Foundation for Continued Growth Georgia has made substantial progress in establishing itself as a competitive life sciences hub. Recent major investment announcements, including UCB’s planned $2 billion biologics manufacturing facility in Gwinnett County and Shriners Children’s planned investment of more than $153 million in a research institute at Science Square, reflect continued confidence in the state's capabilities and potential. The state also benefits from a strong network of research universities, healthcare systems, entrepreneurial support organizations, and innovative companies developing technologies that have the potential to improve patient care and advance medical discovery. Programs and facilities such as Georgia Tech's ATDC, BioSpark Labs, and other regional innovation resources provide important support for emerging companies, helping entrepreneurs move promising ideas toward commercial application. These assets represent a strong foundation for future growth. Addressing the Needs of a Maturing Ecosystem While Georgia's industry continues to advance, emerging MedTech and biotechnology companies face challenges that extend well beyond the state. A changing investment environment, increasingly complex commercialization pathways, and demand for specialized infrastructure are reshaping how early-stage companies develop and grow. The Hypepotamus article highlights some of these pressures, including the recent closure of Portal Innovations' Atlanta location and the challenges startups encounter in securing affordable laboratory space, early-stage capital, and industry connections. These developments underscore the importance of strengthening the support systems that enable innovation. They also reflect a broader opportunity for Georgia to build on its progress and ensure that companies at every stage of development can access the resources they need. “Our biggest opportunity is to become as good at growing and retaining life sciences companies as we are at attracting major investments,” said Thacker Goethe in the article. A Roadmap for Georgia’s Next Chapter This focus on growing and retaining innovative companies is central to Georgia Life Sciences' 10-year strategic roadmap , which outlines priorities to strengthen the state's life sciences ecosystem and long-term competitiveness. The roadmap recognizes that continued industry growth requires a coordinated approach to commercialization, access to capital, specialized infrastructure, workforce development, and partnerships across academia, industry, healthcare, and government. For early-stage companies, those connections are especially important. Access to research facilities, clinical partners, experienced mentors, investors, and manufacturing resources can make the difference between a promising discovery and a successful commercial enterprise. Through its industry councils, strategic partnerships, and ecosystem initiatives, Georgia Life Sciences is working to help strengthen these connections and support the development of an environment where companies can succeed at every stage of growth. Turning Momentum into Long-Term Opportunity Georgia's life sciences story is one of substantial progress and considerable opportunity. The next chapter will require building on that success with the same intentionality that has helped attract major industry investments and expand the state's research and innovation capabilities. That means continuing to support companies choosing Georgia for major investments while also strengthening the pathways that allow homegrown businesses to develop, commercialize, and scale here. The goal is not simply to attract life sciences innovation to Georgia, but to ensure Georgia is a place where innovation can take root, grow, and thrive. The Hypepotamus feature offers a timely perspective on the opportunities ahead and the importance of continued collaboration across Georgia's life sciences community.  Read the Full Hypepotamus Article
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