Enrollment / Retention and Informed Consent

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2024 Agenda

Fri., Sept. 27 1:15 to 2:00 Track: Enrollment / Retention and Informed Consent

Racial and Ethnic Disparity in Clinical Trial Enrollment: How to Quantify the Problem and Implement Tangible Solutions to Solve It

Ms. Fitzpatrick will consider a study to explore disparities in clinical trial participation that examined both qualitative and quantitative data to better understand participant demographics, barriers to participating in CTs, and the recommendations for actionable solutions to improve enrollment diversity. 409

Presenter: Veronica Fitzpatrick, DrPH, MPH, BS, Research Scientist, Advocate Health

Fri., Sept. 27 2:05 to 2:50 Track: Enrollment / Retention and Informed Consent

Medical Misinformation in the Media and the Challenges It Causes in Patient Treatment and Clinical Trials

Dr. Horvath will review some of the significant historical cases where data fabrication caused misinformation which first mislead reviewers then following publication, the general public. 411

Presenter: Peter Horvath, PhD, CCRP, CRA, Trial Specialist, University of California, Irvine

Fri., Sept. 27 3:25 to 4:10 Track: Enrollment / Retention and Informed Consent

The Fundamentals of the Prescreening Process

Ms. Royse will discuss subject recruitment strategies and a step-by-step process that includes the creation and maintenance of a patient database, weekly prescreening logs, and preparing for the first subject screening. 413

Presenter: Martha Royse, BSN, MSN, RN, APRN, FNP, CCRP, Owner, Optimal Trial Screening, LLC

Fri., Sept. 27 4: 15 to 5:00 Track: Enrollment / Retention and Informed Consent

Rolling out the Red Carpet for Research Recruitment

In the ever-evolving world of technology, human interaction is centrally important to the informed consent process. From the study design level all the way to the conduct of patient engagement, adjustments and tactics learned managing investigator-initiated studies at an academic medical institution can yield increased engagement and create a lasting impact on the research participant experience. 415

Presenter: Samantha Eldersveld, BA, CCRP, Clinical Research Project Manager, Nationwide Children's Hospital

Sat., Sept 28 8:30 to 9:15 Track: Enrollment/Retention/Informed Consent

Customize The Subject Journey For Higher Enrollment & Better Retention

A combination of 'how to' and 'what to,' this presentation focuses on reframing the basics of understanding the subject journey proposition into a more useful in-depth tool which can drive engagement throughout the process. Data shared from proven tactics in everything from Phase I through Rare Disease combined with simple and efficient tools to customize the experience for individual sites. A synthesis of data collected for participants to browse/customize--inclduing where to start and how to ensure impact. 417

Presenter: Mark Metzner, BA, Senior Manager, Recruitment & Feasibility, CTI Clinical Trial Services, Inc.

Sat., Sept 28 9:20 to 10:05 Track: Enrollment / Retention and Informed Consent

Recruitment Lessons in Rare Disease Research

In rare disease studies, such as Huntington’s Disease, recruitment can be challenging, given the strict eligibility criteria, mistrust of the medical system after years of disease-related stigma, insurance coverage issues, and the limited population size. Ms. Kuprewicz will discuss strategies to quickly gain trust and build rapport in a patient population, how to tailor recruitment strategies to a specific site, and how to advocate for site-specific needs with study sponsors. 419

Presenter: Robin Kuprewicz, MA, Clinical Trials Director, Georgetown University

Sat., Sept 28 10:50 to 11:35 Track: Enrollment / Retention and Informed Consent

Considerations for Indigenous Participants in Clinical Genetics Testing

Indigenous people largely do not engage in clinical research and genetic testing, which can impact potential clinical utility and relevance for indigenous communities. We will discuss indigenous views of open data sharing, stewardship, data equity, and tribal research regulatory review procedures.421

Presenter: Krystal Tsosie, PhD, MPH, MA, Assistant Professor, Arizona State University

Sat., Sept 28 11:40 to 12:25 Track: Enrollment / Retention and Informed Consent

Trials and Tribulations of Conducting Research in Nursing Homes

Mr. Vishnepolskiy will highlight challenges faced in getting access to nursing homes, identifying which IRB would oversee a study, and the process of collaborating with multiple research sites. 423

Presenter: Igor Vishnepolskiy, MS, CCRP, Clinical Trials Research Coordinator, Lifespan

Sat., Sept 28 1:40 to 2:25 Track: Enrollment / Retention and Informed Consent

Leverage eSource tools to meet Diversity Goals

Regulators have embraced technology to streamline and improve the conduct of clinical trials. Leveraging eSource tools allows regulated entities to meet diversity goals.eSource and DCT technology allows for eligibility across a potential study population and enables a more diverse patient population by breaking down traditional barriers for patients (time, cost, convenience, access). 425

Presenter: Marc Wartenberger, Senior Director, Security, Corporate Quality Assurance & Compliance, CRIO

Sat., Sept 28 2:30 to 3:15 Track: Enrollment / Retention and Informed Consent

Looking Beyond Protocol Eligibility Criteria...the Multifaceted Research Patient

Ms. Yohn will review several case studies to demonstrate the importance of considering patient history, psychosocial factors, and economic stressors when recruiting research participants. Case study analysis will also detail how each facet impacts long-term study retention. 427

Presenter: Marianne Yohn, MMgt, CCRP, MLS(ASCP), Research Project Manager II, Geisinger