DIA 2024 Global Annual Meeting

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-535-L04-P; CME 1.00; RN 1.00

This forum discussion focuses on current state, challenges, and opportunities to enhancing the science of patient input. Panel of experts will discuss examples of approaches with partnering with patients, enanging regulators and measuring progress.

Learning Objectives

Discuss approaches and best practices for partnering and co-creating with patients; Identify strategies to systematically incorporate patient input into decision making; Describe opportunities to enhance interactions between industry and regulators; Discuss approaches to measure progress in engaging patients and its impact to medical product development.

Chair

Pujita Vaidya, MPH

Speaker

FDA Perspective
Michelle Campbell, PhD

Industry Perspective and Case Example
Elizabeth Rosenkrands-Lange, MPH, MS

Patient Researcher Perspective
Bellinda King-Kallimanis, PhD, MSc

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-548-L04-P; CME 1.00; RN 1.00

This “talk-show” style forum is driven by the patient voice to collaborate on clinical research through the eyes of patients, advocates, and caregivers. It illuminates barriers and burdens and provides solutions for industry to raise awareness, participation, and retention in clinical trials.

Learning Objectives

Describe how empowered patient decision making contributes to increased enrollment and engagement in clinical trials; Discuss value proposition for industry to involve patients early and give examples of metrics to quantify and measure: Idxentify unique challenges and wins in the clinical research space, including pediatric trials.

Chair

Aman Khera, MBA

Speaker

Panelist
Stacy Hurt, MBA, MHA

Panelist
Mario Estevez

Panelist
Andrew Schorr

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-577-L04-P; CME 1.00; RN 1.00

This forum will describe strategies for patient engagement to help design patient experience studies (PED). Case studies will illustrate the critical impact of patient engagement on the design of PED studies.

Learning Objectives

Examine the critical role that patient engagement can have on the success of patient experience studies; Implement strategies to overcome challenges associated with patient engagement in hard-to-reach populations.

Chair

Ellen Janssen, PhD

Speaker

Lessons Learned from Publicly Funded Patient Engagement Activities
Caroline Vass, PhD

Industry-Led Case Study
Bennett Levitan, MD, PhD

Industry Update
Brett Hauber, PhD, MA

FDA Update
Robyn Bent, MS, RN

Patient Advocacy Perspective
Bellinda King-Kallimanis, PhD, MSc

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-572-L04-P; CME 1.00; RN 1.00

Improving access and minimizing burdens are critical to ensuring diverse representation in clinical trials. Panelists will discuss efforts to improve patient access to oncology clinical trials through streamlined protocols and decentralized elements.

Learning Objectives

Describe the impact of incorporating decentralized elements (DE) into oncology clinical trials (CTs) on data integrity, patient safety and regulatory approvals; Explain how DE elements increase patient access and recognize opportunities to implement DE; Identify ongoing barriers to implementing DE into CT protocols and solutions to address operational challenges in expanding access to care.

Chair

Suanna S. Bruinooge, MPH

Speaker

How Sponsors, CROs, and Sites Can Work Together
Craig H Lipset, MPH

Meta-Analysis of Trials During COVID
Joseph Unger, PhD, MS

Implementing Trials in Large Healthcare System
Ramya Thota

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-584-L04-P; CME 1.00; RN 1.00

This forum will present metrics developed and tested to understand progress for improving trials by 2030. A panel will provide work in areas of metrics for assessing progress in improving trials and understanding the state of clinical trials in 2024.

Learning Objectives

Discuss current efforts to establish metrics for assessing progress on efforts to improve trials, including improvements to trial design quality and representativeness of trials; Identify areas of trial improvements that may be measured or assessed; Appraise metrics approaches for relevance to improving specific areas of trial operations.

Chair

Summer Starling, DrPH, MPH

Speaker

Panelist
Jennifer Miller, PhD

Panelist
Linda B Sullivan, MBA

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-596-L04-P; CME 1.00; RN 1.00

This forum will explore the U.S. FDA Center for Drug Evaluation and Research's portfolio of clinical trial innovation activities, including its newly established CDER Center for Clinical Trial Innovation (C3TI). C3TI serves as a central hub supporting innovative approaches to clinical trials aimed at improving the efficiency of drug development. Speakers from the FDA will elaborate on C3TI and its role in supporting innovative clinical trial designs. The FDA presenters will be joined by industry and patient speakers for a panel discussion on opportunities to enhance implementation and adoption of innovative approaches in clinical trials, aiming to ensure patient-centric trial design, improve the efficiency of clinical trials, increase the participation of diverse populations, and, in turn, accelerate the development of safe and effective new drugs.

Learning Objectives

Discuss key challenges or barriers to implementation and adoption of innovative approaches in clinical trial design, conduct, and execution; Discuss strategies to enhance implementation and adoption of innovative approaches in clinical trial design, conduct, and execution.

Chair

Meghana Chalasani, MHA

Speaker

Panelist
Kevin Bugin, PhD, MS, RAC

Panelist
Ella Balasa

Panelist
Michelle Rohrer, PhD

Panelist
Allison Cuff Shimooka, MBA

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-614-L04-P; CME 1.00; RN 1.00

Clinical research creates future clinical care. Let's lead in compassionate communication inviting more participation. Patient, site, and patient-focused drug development (PFDD) experts share and invite your participation in improving access through our words.

Learning Objectives

Identify the shame and blame negative words and phrases and their negative impact on patients; Recognize opportunities to improve the patient experience in clinical research as a care option through more compassionate word choice; Describe how to plan and justify optimization of protocol, informed consent, and participant communication language.

Chair

Lani Hashimoto

Speaker

Panelist
Jamie Troil Goldfarb

Panelist
Eddilisa Martin

Panelist
James Duhig, PhD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-611-L04-P; CME 1.00; RN 1.00

In this forum, speakers from regulatory, industry, and research organizations will discuss methodological considerations and evaluate various innovative use cases in different settings that integrate real-world data (RWD) in clinical designs.

Learning Objectives

Discuss global regulatory guidance, frameworks, and best practices for real-world data (RWD) in innovative hybrid study designs for regulatory purposes; Describe innovative approaches and statistical methods for integrating RWD and clinical trial data for clinical decision-making; Appraise use cases where RWD have been used in hybrid study designs to support clinical and regulatory development.

Chair

Rachele Hendricks-Sturrup, DrSc, MA, MSc

Speaker

Panelist
Mehmet Burcu, PhD, MS

Panelist
Christina Mack, PhD, MPH

Panelist
Catherine C. Lerro, PhD, MPH

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-627-L04-P; CME 1.00; RN 1.00

Questionnaires, standardized tasks, and DHTs can measure similar outcomes which complicates endpoint selection. This forum discusses a framework to align ontologies for actively-collected and passively-monitored COAs to streamline endpoint strategy

Learning Objectives

Identify biomarkers from actively collected and passively-monitored COAs building upon regulatory definitions; Determine a framework to align ontologies for these measure types enabling rapid, evidence-based, and fit-for-purpose measure selection using case study examples.

Chair

Caprice Sassano, MPH

Speaker

Panelist
Roya Sherafat-Kazemzadeh, MD, PhD

Panelist
Megan Parisi, MS

Panelist
Thomas Switzer, MEd

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-636-L04-P; CME 1.00; RN 1.00

This forum will address industry challenges in the recruitment and retention of underserved populations in clinical research, and explores how regulators, physicians, sponsors and others can work together to develop solutions to tackle health equity.

Learning Objectives

Identify a proposal for addressing underrepresentation of underserved populations in Europe; Describe regulatory and industry perspectives in addressing recruitment and retention challenges for multi-regional clinical trials; Discuss best practices that can help shape inclusivity of clinical trials across borders.

Chair

Ambily Banerjee, PhD

Speaker

The EU Perspective and the Role of ACT EU
Ana Zanoletty Perez

Evolving FDA Perspective Based on Learningd from DAP Submissions on What Diversity Looks Like
M. Khair ElZarrad, PhD, MPH

Industry Perspective of Community Engagement in Europe: A Case Study
Monique Adams, PhD, MS

CT Network One-Pager v2
Nicholas Brooke, MBA

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-679-L04-P; CME 1.00; RN 1.00

This session will explore, from three complementary perspectives, how to improve diversity in clinical research by actively addressing accessibility, equity, and inclusion throughout the design and implementation of digital health technologies.

Learning Objectives

Summarize the current state and define industry goals related to diversity, equity, and inclusion (DEI) in clinical research; Outline the role of digital solutions in achieving these diversity, equity, and inclusion goals in clinical research; Apply core principles for digital design and implementation with case studies.

Chair

Lindsay Hughes, PhD, MS

Speaker

Panelist
Silas Buchanan

Speaker
Stephanie Ueng

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-681-L04-P; CME 1.00; RN 1.00

This interactive forum will explore the key themes and industry feedback from the decentralized trials alliance members’ response to the FDA draft guidance on decentralized clinical trials.

Learning Objectives

Examine how the FDA draft guidance reflects a commitment to patient-centric decentralized clinical trials; Identify key themes and industry feedback provided in the alliance's response to the draft guidance; Discuss the next steps needed to enable adoption of decentralized trials under the draft framework.

Chair

Rasika Kalamegham, PhD

Speaker

Collaboration Perspective
Jane Elizabeth Myles, MSc

FDA Perspective
M. Khair ElZarrad, PhD, MPH

Industry Perspective
Dylan Bechtle, MS

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-682-L04-P; CME 1.00; RN 1.00

Person-generated data offers nuanced effectiveness measures for clinical and regulatory decision-making for new medical products, like the wearable-derived digital clinical outcome assessment for Duchenne muscular dystrophy. What's next?

Learning Objectives

Describe practical applications of person-generated health data, and key business and regulatory perspectives on opportunities and challenges; Explain the value of this type of information to patients, clinicians, and colleagues to help inform decision-making.

Chair

Nancy A Dreyer, PhD, MPH, FISPE

Speaker

Panelist
Christina Mack, PhD, MPH

Panelist
Paul Strijbos, PhD

Panelist
Jeffrey Nahum Siegel, DrMed, MD

Panelist
Martha Azer, PharmD, RPh

Component Type: Forum
Level: Intermediate

Curious about who shapes the decisions behind medicines approval and inspection? Wondering about the diversity in backgrounds and perspectives within regulatory agencies? Join us for an insightful session delving into the critical role of diversity in medicines development and regulatory decision-making. Ever pondered if your skills could transition you from being regulated to a regulator, or vice versa? Explore how transferable skills can bridge the gap between industry and regulatory roles, fostering diverse thinking essential for patient-centric outcomes. Discover career pathways in both sectors and learn how breadth of experience in seemingly unrelated roles can enrich regulatory processes, including patient advocacy. Don't miss this opportunity to uncover the less trodden path between regulators, the regulated, and patient advocacy. Join us to pave the way for a more inclusive and impactful medicines development landscape.

Learning Objectives

Recognize transferable skills from industry to regulatory roles, fostering diversity crucial for innovation; Assess the panelists' career trajectories transitioning between sectors, gaining strategies for professional growth; Identify the patient advocacy's role, understand how similar transferable skills are utilized to support patient-centric approaches.

Chair

Paula Walker, MA

Speaker

Panelist
Sophie Radicke, MSc

Panelist
Patroula Smpokou, MD