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Tuesday, June 17
 

10:30am EDT

#221: Participant Compensation in Clinical Trials: Exploring Today’s Landscape and Unlocking Opportunities
Tuesday June 17, 2025 10:30am - 11:30am EDT
201
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-568-L04-P; CME 1.00; RN 1.00

In a rapidly evolving clinical trial landscape, breaking down financial barriers is essential to foster participant enrollment, improve retention, and ensure the success of trials.

Learning Objectives

Identify key findings from DIA’s Participant Compensation Landscape Analysis and discuss their implications to promote diversity and support clinical trial outcomes; Recognize participant-centric strategies to address financial barriers in clinical research, enhancing diversity in trial participation; Discuss collaborative approaches to further understand participant compensation practices.

Chair

Carie Pierce, MS

Speaker

Moderator
Donna Libretti Cooke, JD

Panelist
James Lovett, JD

Contributor-Industry
Karen Correa, PhD

Contributor-Academia
Kenneth Getz, MBA


Speakers
avatar for Donna Libretti Cooke

Donna Libretti Cooke

Chief Impact Officer & Owner, ImpactSphere Clinical, LLC, United States
DONNA LIBRETTI COOKE, JD Chief Impact Officer & Owner ImpactSphere Clinical, LLC A compassionate pioneer driving clinical trial solutions for a healthier world. Donna is a strategic & collaborative Life Sciences professional with a ‘dive-in’ mindset and an extensive track record... Read More →
avatar for Karen Correa

Karen Correa

Vice President, Clinical Development Operations, Boehringer Ingelheim, United States
Dr. Karen Correa is the Vice President, Head of Global Development Operations at Boehringer Ingelheim; where she is responsible for the advancement of the portfolio and execution of global clinical trials in the US. Her 30 years of clinical research experience cover a large range... Read More →
avatar for Kenneth Getz

Kenneth Getz

Tufts Center for the Study of Drug Development, Tufts University School of Medicine, United States
Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical... Read More →
avatar for James Lovett

James Lovett

CEO, Myonex, United States
James Lovett is Chief Executive Officer and Board Member of Myonex Inc., a leading clinical trial supply company with operations in US, France, Germany and UK and distribution to 80 countries. Myonex partners with pharma and biotech companies, CROs, and other pharma service providers... Read More →
avatar for Carie Pierce

Carie Pierce

Global Head of Growth & Business Development, DIA, United States
Carie serves as Global Head of Growth for DIA. She comes to DIA with over 25 years in the Medical Device, Diagnostic, and Pharmaceutical industry. She has spent much of her career with Terumo Blood and Cell Technologies in various commercial leadership roles, including responsibility... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
201 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Forum |   02: ClinTrials-Ops, Forum
  • Level Intermediate
  • Keyword Bioethics
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Feature Topics Bioethics
  • Tags Forum

1:45pm EDT

#241: Updating Ethics: What’s New (and why it Matters!) in the 2024 Declaration of Helsinki Revision
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
204ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-579-L04-P; CME 1.00; RN 1.00

This session will review the 2024 revision of the Declaration of Helsinki, one of the foundational codes of clinical research ethics, and the rationale and practical implications of the changes made in the current version.

Learning Objectives

Discuss the history of the Declaration of Helsinki and its relevance and importance for the healthcare industry; Recognize the changes made in the 2024 version and how they will impact the conduct of biopharma clinical trials; Discuss multi-stakeholder efforts that are working towards operationalizing ethical principles in the DOH and where more collaboration and alignment is needed.

Chair

Melissa Heidelberg, MS

Speaker

Speaker
Karla Childers, MS

Speaker
Ann Meeker-O'Connell, MS


Speakers
avatar for Karla Childers

Karla Childers

Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson, United States
Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility... Read More →
avatar for Melissa Heidelberg

Melissa Heidelberg

Director, Global Bioethics and Technology Ethics Lead, Takeda, United States
I am a Bioethicist by training with more than 20 years’ experience in industry across various global roles in Research and Development and Pre-competitive Industry Collaborations. I have a passion for evolving and implementing ethical frameworks to address emerging tensions at the... Read More →
avatar for Ann Meeker-O'Connell

Ann Meeker-O'Connell

Director, Office of Clinical Policy, FDA, United States
Ann Meeker-O’Connell is the Director of FDA’s Office of Clinical Policy in the Office of the Commissioner. In this role, she leads an organization that develops and implements cross-cutting policy related to clinical development and research ethics. Ms. Meeker-O’Connell has... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

4:00pm EDT

#263: Using Generative AI to Explore our Track Record on Paying Participants: What Can We Learn to Support More Diverse Representation
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
209ABC
Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-595-L04-P; CME 1.00; RN 1.00

We present trends and insights from an analysis of participant payment language of more than 7,500 consent forms reviewed by a large, independent IRB and discuss the ethical implications of insufficient compensation for trial participants.

Learning Objectives

Explain trends and insights in clinical trial participant payments based on 7500 clinical trial ICFs collected and analyzed between 2019 and 2024; Examine the language used to describe payments and how that impacts participants; Discuss ethical issues and assumptions about IRB approval of participant compensation for research.

Chair

Kelly Fitzgerald, PhD

Speaker

Panelist
Kelly Fitzgerald, PhD

Panelist
Donna Libretti Cooke, JD


Speakers
avatar for Donna Libretti Cooke

Donna Libretti Cooke

Chief Impact Officer & Owner, ImpactSphere Clinical, LLC, United States
DONNA LIBRETTI COOKE, JD Chief Impact Officer & Owner ImpactSphere Clinical, LLC A compassionate pioneer driving clinical trial solutions for a healthier world. Donna is a strategic & collaborative Life Sciences professional with a ‘dive-in’ mindset and an extensive track record... Read More →
avatar for Kelly Fitzgerald

Kelly Fitzgerald

Executive IRB Chair and Vice President of IBC Affairs, WCG , United States
Kelly FitzGerald is the IRB Executive Chair and Vice President of IBC Affairs at WCG IRB where she oversees the operation of both the IRB and several hundred institutional IBCs. Kelly is a certified IRB professional and holds a B.S. in Chemical Engineering from the University of New... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum
 
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    Advanced Analytics
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143ABC
144ABC
145AB
146ABC
146BC
147AB
150AB
151A
151B
152AB
201
202A
204ABC
206
207A
207B
209ABC
Ballroom
Ballroom Foyer 3rd Floor
EH
Exhibit Hall / Zone A
Exhibit Hall / Zone B
Exhibit Hall / Zone C
Exhibit Hall Lunch
Innovation Theater 1
Innovation Theater 2
Innovation Theater 3
L Street Bridge
Nationals Park
Planet Word
Room 145-147 Lobby
Salon B
Salon C
TBD
Virtual
West Salon
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD-Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: ProfDevelopment
  • 13: Spotlight
  • 14: DIAmond
  • 15: Content-Hubs
  • 16: Community-Rounds
  • 17: Posters
  • 18: InnovationTheaters
  • 19: Networking Opportunities
  • 20: Short-Courses
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Keyword
  • Advanced Analytics
  • Artificial Intelligence (AI)
  • Bioethics
  • Biomarkers
  • Cell and Gene Therapy
  • Clinical Trial Design
  • Diagnostics
  • Digital Technology
  • Global Perspectives
  • Non-CE
  • Patient Experience
  • Payers
  • Pediatrics
  • Rare Disease
  • Real-World Data (RWD) / Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
  • Regulatory Convergence and Harmonization
  • Regulatory Reliance
  • Student Programming