Posters

Explore innovative ideas, research findings, and best practices in clinical research through our engaging poster presentations, displayed in the Expo Hall during open hours. Educational posters are visual summaries designed to present key information in a clear, concise, and compelling way. They allow researchers and professionals to share their work, spark discussions, and inspire new approaches to clinical research challenges.

Authors will be available for in-person Q&A at 1:30 PM on Friday and Saturday. We encourage attendees to stop by, view the posters, and engage with the presenters to deepen their understanding of the projects and connect with peers.

A Human Rights Committee: Enhancing a Participant-Centered Approach to Research

Success in clinical trials is very dependent upon the participants. Engagement, even more than enrollment, facilitated by trust, communication, and education is essential and consistent with the research approach employed by high reliability organizations. This poster describes the development, implementation, and conclusions made by a Human Rights Committee. Their primary goal is to represent and advocate for participants around ethical considerations in research. A participant-centered perspective of the research experience is beneficial to understanding and the enactment of meaningful change when required. Utilizing a Plan-Do-Study-Act methodology the Human Rights Committee has been well received, demonstrates value, and facilitates continuous improvement. Activities conducted by the Committee, including but not limited to review of protocols and informed consent forms and the conduct of participant interviews, provide a voice to participants and a unique insight to study teams. The Human Rights Committee has enriched this research program and increased our focus on participants.

Author: Kathleen Howard, DNP, RN, Quality Assurance Nurse Specialist, VA Boston Cooperative Studies Program Coordinating Center

Biospecimen Collection: The Cornerstone of Clinical Trials

Biospecimen collection plays a role in helping us understand disease mechanisms, biomarker discovery, and efficacy assessment. When lab kits and directions are not followed correctly, it can result in degradation, contamination, loss of the biospecimen, and delays. It is important that clinical trial sites and staff take measures to ensure proper biospecimen collection. This can be accomplished by developing standard operating procedures, providing proper training for clinical staff and lab technicians, conducting regular audit checks, maintaining the proper equipment and staying ahead of low supplies, and ensuring accurate labeling and documentation. Lastly, it is important that site staff align collection and handling for central labs with the protocols provided. Biospecimen collection and analysis should be considered the cornerstone of clinical trials. By implementing these measures, clinical trial sites can ensure the proper collection, handling, and storage of biospecimens, thereby maintaining the integrity of the trial data.

Author: Kay Murphy, Clinical Research Coordinator, Innovo Research

Building Research Capacity and Advancing Equity in Community Oncology Clinical Trials: A Pilot Training Program

Expanding clinical trial access in community oncology settings is critical for improving diversity, equity, and inclusion (DEI) in cancer research. The Association of Cancer Care Centers (ACCC) initiated a program to identify and support cancer centers that were research naïve or less experienced in oncology clinical research with regionally, racially and ethnically diverse catchment areas. This initiative aimed to build research capacity, leveraging ACCC and ACRP resources to enhance clinical trial infrastructure while fostering racial and ethnic inclusion.

Authors: Kimberly Demirhan, MBA, BSN, RN, Assistant Director, Education Programs, Association of Cancer Care Centers (ACCC); Latha Shivakumar, PhD, Senior Director, Clinical Education and Research, Association of Cancer Care Centers (ACCC)

Ghosting? More than a Dating Trend

Clinical Research Coordinators, Clinical Research Associates, and working professionals across the globe have transitioned to remote work due to COVID-19 restrictions and industry demands over the past four years. This shift has required professionals to work from home, with hospitals and clinics granting remote access to accommodate restrictions on on-site visits. However, the lack of in-person oversight has led to challenges in maintaining transparency in work, managing employer-employee relationships, deliverables, and fulfilling contractual obligations. In a term borrowed from modern courtship behaviors, "Ghosting " and "Quiet or Slow Quitting " will be presented within the organizational framework of the clinical research setting. Three brief case studies regarding the identification of changes in remote employee behavior with audience interaction will be included. We aim to provide a decision tree framework for triaging early behavior manifestation before the evolution of a trend that becomes detrimental to the clinical study life cycle.

Authors: Leah Orozco, MS, CCRA, Clinical Trial Manager, Moderna; Estela Staggs, MSN, MCRA, Senior Clinical Research Associate, Icon

How to Be Your Own Internal Study Monitor

The overall focus and goal of the session is to prepare anyone, from a principal investigator to an interning research assist, to audit study materials. To be shared in the poster will first be how to properly document all necessary study components such as a regulatory binder. The poster will also review how to prepare and conduct an internal audit. The poster will elaborate on how to prepare an audit record, how to locate the materials that need to be audited, mitigation steps for insufficiencies found during an audit, and how to prepare an audit report. The poster will include who audit reports should be reported to, such as the PI, a regulatory binder, the sponsor, and in some cases, the IRB. Supporting topics will be the importance of regulatory document maintenance, financial compliance (such as documenting receipts and subject compensation tracking), and record keeping best practices.

Author: Ann-Marie Jacobson, Senior Research Affairs Specialist, Tufts University School of Dental Medicine

It’s Not You, It’s Me. Where Do We Go Now?

We will discuss the financial and ethical impacts of "Ghosting " and "Quiet or Slow Quitting " phenomena on the life cycle of clinical research studies and offer interdisciplinary solutions for detecting and correcting these behaviors. We will compare domestic and global data and provide real-time estimates to illustrate the true cost of duplicated effort and lost time. Furthermore, we will delve into the current ethical standards and take a firm approach to understanding the evolving meaning of due diligence in the post-COVID-19 clinical research environment. Our efforts will focus on reducing these trends, and we will present three brief case studies to showcase real-world efforts combatting these occurrences. By drawing lessons from these case studies, we will offer practical strategies that may be implemented in various research settings. Ultimately, our goal is to promote a culture of transparency in clinical research practices that is reliable and ethically sound.

Authors: Leah Orozco, MS, CCRA, Clinical Trial Manager, Moderna; Estela Staggs, MSN, MCRA, Senior Clinical Research Associate, Icon

Patient-Centered Consent: Bridging Trust in Clinical Research

The clinical trial consenting process ensures ethical participation and is crucial for patient safety, but it is also an important opportunity to build trust. One approach to consenting is the top-down learning method: begin with the purpose of the study and essentials such as why you were chosen before diving into the complexities of the trial. By starting with the primary purpose and potential benefits of the trial, patients can quickly grasp the overall significance and relevance to their health, which helps in establishing trust and a positive initial impression. This approach ensures that patients are not overwhelmed by technical details from the onset, allowing them to form a solid foundational understanding before being introduced to more intricate aspects such as procedures, risks, and logistical considerations. Consequently, patients are more likely to feel informed, less anxious, and more engaged in the decision-making process, leading to truly informed consent.

Authors: Halley Losekamp; Brinda Nagaraj, Senior Clinical Research Coordinator, Innovo Research

Pediatric Site Response to Rapid Implementation of Decentralized Clinical Trials (DCTs)

The COVID-19 pandemic drastically altered the way clinical research is conducted through a widespread adoption of telemedicine practices to continue clinical trial procedures during peak periods of global COVID-19 spread. Using telehealth/telemedicine services allows researchers to conduct "decentralized clinical trials", or DCTs, for all or portions of study protocol procedures while maintaining safety measures implemented for pandemic control. However, research sites are hesitant to adopt DCT policies due to concerns around digital health technology, data safety and quality, and limited information in the literature specifically assessing telemedicine use for pediatric clinical research via DCTs or how equipped pediatric research sites are for the transition away from the site. A cross-sectional, observational case study surveying clinical research professionals (CRPs) at a local pediatric institution in Kansas City, MO, was conducted to better understand pediatric site facilitators and barriers to implementation and utilization of DCTs from a site perspective.

Author: Abigail Kietzman, MSB, ACRP-CP, Sr. Clinical Research Coordinator, Children's Mercy Kansas City

Site-Enabled Decentralized Clinical Trial Model for Rare Diseases

Traditional decentralized clinical trial (DCT) models heavily rely on external home health agencies to provide trained staff for conducting study visits in subjects' homes. Rare disease and pediatric trials pose unique challenges due to patient fragility and complex protocol designs. Site-enabled research home health solutions revolutionize clinical trials by providing staff trained at clinical sites, enhancing participant participation, comfort, and compliance. Home research professionals conduct visits, administer treatments, and monitor participants, ensuring adherence to rigorous study protocols while maintaining high standards of safety and efficacy. This innovative approach minimizes travel burdens, particularly benefiting individuals with mobility limitations or those residing far from study centers. Patients receive personalized care by specialized staff fostering a supportive environment conducive to accurate data collection and retention. Real-time data collection via digital platforms further streamlines communication among patients, caregivers, and research teams, optimizing trial efficiency and data integrity.

Authors: Amy Chestnut, Director of Human Resources, Rare Disease Research, Gooseberry Research, Davesa Health and Phan Institute of Clinical Research; Alpha Khushalani, Head of Customer Success & Delivery, Gooseberry Research

Understanding the Role of CROs and Sponsors During the Feasibility Process to Increase Enrollment for Racial and Ethnic Minorities in Clinical Trials

Clinical trials are fundamental to medical advancements, yet racial and ethnic minorities remain underrepresented, raising ethical and medical concerns. This research addresses this disparity by exploring the roles of Contract Research Organizations (CROs), sponsors, and regulatory bodies in the feasibility process. By examining historical contexts, ethical considerations, and barriers, this study aims to provide insights into improving minority enrollment. Drawing on existing research, including studies by Fain et al., 2021; Turner et al., 2022; and Florez et al., 2022; the proposal underscores the importance of diversity in trial representation and offers recommendations for more equitable participation. Through meticulous methodology involving data analysis from ClinicalTrials.gov and disease-specific categorization based on race/ethnicity, this research aims to inform strategies that foster inclusive clinical research landscapes, ultimately ensuring medical interventions benefit all demographics.

Author: Jalen Denson, Public Health Student, Juniata College