Double Dippers: The Secret Lives of Serial Study Subjects

Clinical trials rely on valid results from study participants to ultimately advance a product to market but a quickly growing number of participants enrolled in a trial could potentially be enrolled in multiple trials at different research sites, and the problem is expected to get worse.

Recognizing that these “professional participants” or “duplicate participants” may present safety risks to themselves, skew results and impact study outcomes, drug development sponsors need to understand how to prevent professional participant enrollment and perform appropriate pre-screening as part of their comprehensive recruitment strategy.

In this webinar, the speakers will first discuss the many reasons that participants may attempt to enroll in multiple studies — whether they are motivated financially or seeking access to standard healthcare or a novel treatment — and the typical methods used for enrolling in a study.

Citing recent statistics, they will also share the types of large-scale studies that have been impacted by this ongoing issue, which can be compounded when multiple sites are in the same city. The perspectives of sites will also be discussed to provide insights into the standard due diligence required at the site level to weed out professional patients.

For example, sites continually face the challenge of relying on participant-supplied information, such as health conditions, current symptoms, current use of prescribed medication and/or recreational drugs and even valid identification. As the enrollment of professional patients in a trial can lead to biased or unreliable data, attendees will learn about their overall impact to study integrity and the burden sponsors often face in identifying and rectifying problematic data.

The webinar will conclude with a discussion of several measures that can help prevent multiple enrollments and enhance patient safety as part of a structured Quality by Design initiative. The experts will also share proactive operational strategies from site selection techniques to protocol design. Finally, attendees will learn how preventative technologies can help identify duplicate participants, confirm eligibility and ensure the selection of high-quality subjects.

Register for this webinar today to delve into the reasons behind multiple patient enrollments and the challenges faced by sites during participant screening and impact on large-scale clinical trials.

Speakers

Melissa Harris, Head of Global Patient Recruitment and Engagement, Fortrea

Melissa Harris has 23 years of industry experience dedicated to accelerating patient recruitment from all possible feeds, including site EHRs, AI and data-enabled recruitment channels, digital and online media and community engagement programs.

Melissa works to harness the benefits of applying innovative solutions toward successful patient recruitment and retention campaigns while driving health literacy, diversity and inclusion and patient access equity to reduce study burden and facilitate enrollment into everyday life.

Read more...

Melissa heads Fortrea’s Voice of Patient program to drive patient insights into every step of the drug development paradigm and is a Co-Lead of Fortrea’s Site Advisory Board.

Read Less...

Message Presenter

Dr. Patrick McLeroth, MD, Vice President and Therapeutic Area Head, Fortrea

Dr. Patrick McLeroth is the Vice President and Global Therapeutic Area Head for Infectious Diseases and Critical Care and is based in Pennsylvania, US. Dr. McLeroth has more than 23 years of clinical trial experience, including as a Principal Investigator and roles of increasing responsibility at Fortrea focused on planning and execution of infectious disease and critical care clinical development from first-in-human (FIH) to registration and post-marketing trials.

Dr. McLeroth has provided significant contributions to several approved antibiotics and has co-authored more than 20 papers in infectious disease. Since 2008, he has worked as the lead medical monitor on multiple protocols covering all aspects of infectious disease, including HIV, hepatitis B, hepatitis C, influenza, bacterial infections, fungal infections, tuberculosis and vaccines.

Read more...

Prior to joining Fortrea, he worked at Chase Brexton Health Services, Inc. in Baltimore, MD, as Director of HIV Medicine and Research, and was Principal Investigator on more than 30 protocols between 2002 and 2008.

Dr. McLeroth completed his MBBCh degree at the University of the Witwatersrand in South Africa and his internship at the Baragwanath-Chris Hani Memorial Hospital in Johannesburg. Dr. McLeroth completed his fellowship in infectious disease and his residency in internal medicine at St. Luke’s-Roosevelt Hospital in New York City. Dr. McLeroth has been with Fortrea, formerly Labcorp, since July 2008.

Read Less...

Message Presenter

Andrew Cwiertniewicz, MSN, RN, Senior Director, Global Project Delivery, Vaccines, Fortrea

Andrew Cwiertniewicz is an accomplished professional with extensive expertise in vaccine clinical development. Based in Pennsylvania, he serves as a Senior Delivery Director for Infectious Diseases and Critical Care. Throughout his career, Andrew has more than 20 years of experience working with pharmaceutical companies such as Pfizer and Sanofi, and within Contract Research Organizations (CROs).

Prior to these roles, Andrew also worked directly with patients in various healthcare and research institutes providing him direct site experiences in research studies.

Read more...

Andrew’s work has spanned the entire spectrum of vaccine clinical development, from infants to older adults. His efforts have contributed to vaccine licensing on a global scale as well as notable efforts in several pandemics. He possesses in-depth knowledge of all phases of vaccine development, including clinical research and clinical trial strategy.

Andrew earned his MS in Nursing from Drexel University, BS in Nursing from Cedar Crest College and a graduate nursing degree from St. Luke’s School of Nursing. Andrew served more than 15 years in the United States Army Reserve as a Lieutenant Colonel, Executive Officer for the 8th Medical Brigade (New York, NY). He is a veteran with more than 28 months on active duty for Operation Iraqi Freedom and Operation Enduring Freedom.

He is a graduate of various military officer programs, military medicine programs and schools including chemical, biologic, nuclear and explosive warfare. Andrew joined Fortrea in July 2023..

Read Less...

Message Presenter

Justin Goodarz, Chief Commercial Officer, Verified Clinical Trials

As Chief Commercial Officer at Verified Clinical Trials, Justin oversees Business Development & Strategic Partnerships with Pharma/Biotech sponsors, CROs, research sites (privately owned, networks and AMCs) and technology companies.

Prior to joining VCT, Justin has worked at various industry leading companies (Greenphire, WCG Trifecta, SiteRx) focused on enhancing patient recruitment, site & patient centricity, and caregiver centricity & support through the implementation of therapeutic area-specific and enterprise-wide eClinical technology.

Message Presenter