During Clinical Trials Week, the MRCT Center premiered a weeklong “What’s Your Why?” video series, featuring eleven patients, caregivers, and health professionals who share the personal motivations that drive their commitment to research. From cancer survivors whose trial experiences became today’s standards of care to caregivers finding hope in each study visit, these firsthand stories exemplify why amplifying the voices and lived experiences of participants is vital: it ensures that trial design is ethical, practical, and truly centered on those it aims to serve.
Now it’s your turn: record a brief video telling us What’s Your Why? and send it to mrct@bwh.harvard.edu or tag us on LinkedIn with #WhatsYourWhy—because every voice counts in shaping safer, more effective treatments.
🎥 A Powerful Why
For Amanda Monteiro, it’s personal. After losing her 20-month-old daughter to leukemia, she champions clinical trials to help uncover new treatments and better outcomes for patients everywhere.
What’s Your Why? #ClinicalTrialsWeek #WhatsYourWhy #ClinicalResearchMatters #MRCTCenterVoices
🎥 A Caring Why
Normand Neault cares for his wife, Marilyn, after her Parkinson’s Disease diagnosis. “Clinical trials give us hope,” he says, highlighting the encouragement they find in being involved—working alongside experts, seeing her neurologist more often, and lifting each other up. For this caregiving duo, trial participation is a positive step forward, together.
What’s Your Why? #ClinicalTrialsWeek #WhatsYourWhy #ClinicalResearchMatters #MRCTCenterVoices
🎥 A Quality-of-Life Why
Living with chronic pain, Linda Hunter strives for the best possible care—and she trusts clinical trials to deliver it. She wants researchers actively working on diagnosis, treatment, and management that help her live fully, and she insists on having a voice in studies that matter to her.
What’s Your Why? #ClinicalTrialsWeek #WhatsYourWhy #ClinicalResearchMatters #MRCTCenterVoices
🎥 A Hope-Driving Why
Marta Botanch—a pediatric cancer survivor turned hematology nurse—experienced firsthand the impact of clinical research. Her trial treatment not only worked for her but has since been approved and is helping countless children. She champions research because it drives innovation, improves patient care, and ensures safe, effective therapies tailored to young patients—offering hope, dignity, and a future where every child has access to the best care.
What’s Your Why? #ClinicalTrialsWeek #WhatsYourWhy #ClinicalResearchMatters #MRCTCenterVoices
🎥 A Bridge-Building Why
After her cancer diagnosis, Roberta Albany recognized a disconnect between the medical community and marginalized populations, especially African American communities. “Clinical trials save lives—not just yours, but lives that come after,” she says, and calls on us to be part of the solution—unlocking breakthroughs that enhance quality of life for all.
What’s Your Why? #ClinicalTrialsWeek #WhatsYourWhy #ClinicalResearchMatters #MRCTCenterVoices
🎥 A Surthriver’s Why
Robert Weker, a 3-time cancer “surthriver,” credits his survival to the bravery of earlier trial participants: “I was able to stand on their shoulders—those treatments became today’s standard of care.” Guided by his belief that all patients deserve informed decisions, he champions clinical trials to fuel tomorrow’s breakthroughs.
What’s Your Why? #ClinicalTrialsWeek #WhatsYourWhy #ClinicalResearchMatters #MRCTCenterVoices
🎥 A Survivor’s Why
After battling stage IV melanoma, T.J. Sharpe credits clinical trials with saving his life—and giving hope to thousands walking in his shoes. His message: without research, patients lose access to their best possible options.
What’s Your Why? #ClinicalTrialsWeek #WhatsYourWhy #ClinicalResearchMatters #MRCTCenterVoices
🎥 An Advocate’s Why
Marilynne Quarcoo, a long-time participant and patient advocate, shares how letting go of anxiety around research revealed a powerful truth: each of us can contribute to better health care for countless others.
What’s Your Why? #ClinicalTrialsWeek #WhatsYourWhy #ClinicalResearchMatters #MRCTCenterVoices
🎥 A Determined Why
Diagnosed in her 20s with an unknown subtype of Muscular Dystrophy, Keisha Greaves lives every day without a cure and with only physical therapy as a standard option. “How do we know what will work unless we try it?” she asks—driven by the belief that volunteering for clinical research can unlock treatments not just for her, but for everyone in the disability community.
What’s Your Why? #ClinicalTrialsWeek #WhatsYourWhy #ClinicalResearchMatters #MRCTCenterVoices
🎥 An Empowerment Why
Living with Parkinson’s, Marilyn Neault finds that clinical trials give her a crucial sense of control—helping her benchmark her health and learn more about her condition. “Clinical research is vitally important to me,” she says, driving progress for herself and others.
What’s Your Why? #ClinicalTrialsWeek #WhatsYourWhy #ClinicalResearchMatters #MRCTCenterVoices
🎥 A High School Student’s Why
Having to undergo medical procedures designed for adults catalyzed Anvita Ambardekar’s passion for clinical research and pursuit of a biomedical career. Young people like Anvita are the future of innovation and scientific advancements, and her clear-eyed plea for clinical research that focuses on improving healthcare for children and teenagers is a reminder to all of us who champion representation in clinical trials.
What’s Your Why? #ClinicalTrialsWeek #WhatsYourWhy #ClinicalResearchMatters #MRCTCenterVoices
Published on: November 18, 2024 and updated on May 30, 2025
Sexual orientation and gender identity (SOGI) may influence disease risk, incidence, severity, manifestation, and treatment response. In line with the clinical research guiding principles in the Belmont Report of respect for persons, beneficence, and justice, we have developed a toolkit to support equitable participation of people who are LGBTQIA+. The toolkit contains seven tools. Any audience can use the full toolkit, although it should be noted that first four tools are directed more toward sponsors and research teams, and the latter three are directed more toward participants. The first four tools were publicly released individually in the spring of 2024, and the latter were released in November 2004. We invite you to explore the full toolkit or to focus on the specific tools that you find most important to your individual or organizational journey in clinical research.
The authors press for follow‑up models that reduce patient and caregiver burden, improve retention, and leverage decentralized methods and real‑world evidence. Achieving this vision will require sustained collaboration across disciplines and meaningful engagement with patient communities.
Chapman et al., Patient-centered long-term follow-up for gene therapies aligns with ethics and science, Molecular Therapy (2025), https://doi.org/10.1016/j.ymthe.2025.04.040
Barbara Bierer and Willyanne DeCormier Plosky co-authored an article, led by David Gerber (UT Southwestern), in the Journal of Clinical Oncology titled, “Financial Toxicity in Cancer Clinical Trials: An Issue in Need of Clarity and Solutions.” This work was spearheaded by the Equitable Access to Clinical Trials (EACT) Project, hosted by Lungevity, of which the MRCT Center is one participating organization. The article illustrates some of the non-medical costs that cancer trial participants often pay out-of-pocket, such as an average of $600 US for travel, which are an additional stressor during a difficult time for participants and their families. The authors then detail financial support approaches to address these costs, and special considerations for sponsors, contract research organizations, and sites. Finally, the article highlights recently introduced federal legislation that could significantly ameliorate some of the barriers for sponsors trying to implement financial support approaches and for participants trying to access them.
Published in:The Journal of Empirical Research on Human Research Ethics
Barbara Bierer and Willyanne DeCormier Plosky co-authored an article, led by Emily Nguyen (University of Virginia) and David Resnik (NIEHS/NIH), in the Journal of Empirical Research on Human Research Ethics titled, “An Analysis of Institutional Review Board Policies for Enrollment of Adults with Impaired or Uncertain Decision-Making Capacity.” Some people (at some times) may have uncertain or impaired decision-making capacity, due to medication side-effects, cognitive or developmental disabilities, psychiatric disorders, dementia, physical or emotional trauma, or stress. Unless it is determined that they lack capacity and require a legally authorized representative, people with uncertain or impaired decision-making have the right to decide for themselves, with assistance such as supported decision-making (if desired), whether they would like to participate in clinical trials. However, they must first be offered an equal opportunity to participate. We explore in this paper how this equal opportunity, legally supported by Section 504 of the Rehabilitation Act, may be affected by Institutional Review Board (IRB) policies that are oriented towards exclusion rather than inclusion.
A common misconception is that plain language is only needed in select situations. In reality, applying health literacy best practices—such as using clear, thoughtfully designed language—benefits everyone, including professionals working in highly technical fields like data science.
In this on-demand webinar, originally presented on May 8, 2025, leaders from the Society for Clinical Data Management (SCDM), the Clinical Data Interchange Standards Consortium (CDISC), and the MRCT Center explore the essential role of plain language tools, such as the Clinical Research Glossary, in advancing understanding and engagement. They share how their organizations are fostering a culture of health literacy that supports both industry professionals and the broader research community, including patients, participants, and caregivers.
Innovative approaches to long-term follow-up (LTFU) in gene therapy (GT), including Registries and Platform Trials. While GTs may offer transformative health benefits, long-term safety monitoring is often essential and can span years or decades. Our panelists will explore scientific and logistical challenges, along with emerging solutions.
Join us on June 24 from 12 – 1 PM ET to learn about the MRCT Center’s Clinical Research Glossary, a collaboratively developed plain language resource designed to enhance understanding of clinical research terminology. Discover how you can participate in the annual Public Review—an essential step toward making these terms a CDISC global standard. Your involvement ensures the glossary remains accurate, inclusive, and effective for informed decision-making in clinical research.
Key Topics:
Why your voice matters in Public Review
How to easily participate and submit feedback
The role of Public Review in shaping global clinical research standards
The terms and definitions going through Public Review
More about the Advancing Pediatric Platform Trials: Streamlining Development, Maximizing Impact conference:
The MRCT Center hosted a 2-day hybrid meeting in Washington DC in October 2024 to examine the potential benefits, challenges, and opportunities of platform trials for pediatric populations. In addition to consideration of overarching issues, three diseases – pediatric oncology, major depressive disorder (MDD), and multidrug-resistant tuberculosis (MDR-TB) – were chosen to represent different conditions, epidemiology, settings, therapeutic challenges, and patient populations, and to illuminate different potential approaches and solutions.
With ~80 pediatric and platform trial experts from Europe, the UK, Asia, Australia and the US in attendance, the discussants were successfully identified knowledge gaps and practical challenges that impact pediatric platform trial planning and execution. Each of the three subgroups recommended actionable approaches to address identified issues, and the respective groups continued to meet and take concrete steps, furthering the momentum created at the workshop, with the MRCT Center remaining actively involvedwith each disease-specific subgroup to facilitate the next steps.
Please join us on Thursday, June 26, from 1:00-2:00 pm ET, for a webinar in which we will discuss patient-centered approaches in the specific context of Gene Therapy (GT) Long-Term Follow-Up (LTFU) studies.
GTs have the potential for long-lasting and transformative health benefits, but there are also possible long-term health risks. Therefore, the FDA recommends long-term safety monitoring of recipients of certain types of GTs to minimize and better understand any health risks. Although important, these LTFU studies can last years and may pose significant burdens on patients, so it is critical to consider patient needs and preferences in the design and conduct of LTFU for GTs.
Three panelists will offer different perspectives on how we can put patients at the center of LTFU for GTs:
George Eastwood serves as Executive Director for the Emily Whitehead Foundation (EWF). The EWF funds groundbreaking research for pediatric cancer patients while simultaneously advocating for increased access to innovative therapies and supporting patients on their treatment journey. Mr. Eastwood will provide an overview of the Foundation’s work on addressing concerns about patient loss to follow-up in GT LTFU studies.
Dr. Jessica Scott is CEO of Legacy Health Strategies. As a patient engagement leader, she works to drive the culture change of increasing patient perspectives in the health care industry, which in turn will propel mutually beneficial outcomes for organizations and the patients they serve. She will share perspectives on how patient-centric approaches can be applied to GT LTFU.
Tesha Samuels has journeyed from a Sickle Cell patient to a beacon of hope, advocacy, and activism. Her story is a testament to the power of patient voices in shaping better, more compassionate healthcare systems. Her nonprofit, Journey to ExSCellence, is dedicated to empowering individuals affected by Sickle Cell Disease. Ms. Samuels will share perspectives on GT LTFU as both a patient herself and an advocate for others.
