DIA 2022 Global Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-513-L04-P ; CME 1.00; RN 1.00

Adaptive designs are accepted by regulatory agencies so why aren't more sponsors using them? These trials enable sponsors to fail faster and focus effort on where they succeed. We will cover the process from protocol design to interim analysis and communication to key stakeholders for adaptations. There are too many reasons why adaptive designs should be used on more clinical trials. This session will explore those reasons and benefits.

Learning Objectives

Identify the types of adaptive trials; Describe best practices and recommendations for the protocol design phase as well as pre-study planning; Identify what communication is needed to conduct the interim analysis; Assess which stakeholders should be part of this process; Discuss how success should be defined.

Chair

Marc Kaufman

Speaker

Using Trial Simulations to Provide Tailored Adaptive Design in Early Stage Clinical Trials
Song Wang, PhD, MS

Impact of Adaptive Trials to Global Clinical Supply Plans
Haneen S Mazahreh, MS

Adaptive Designs: CRO Perspective
Russell Reeve

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-526-L04-P ; CME 1.00; RN 1.00

Master protocols enable innovative complex trials but can be highly detailed and challenging to review, which can impede their successful implementation. The TransCelerate Common Protocol Template can be a framework for developing master protocols.

Learning Objectives

Identify key considerations for preparing master protocols; Apply the Common Protocol Template to master protocols; Recognize opportunities to utilize the IMI EU-PEARL integrated research platform framework, including a master protocol template, to set up a platform trial.

Chair

Nancy Tam, MS

Speaker

Industry Update
Madhavi Gidh-Jain, PhD

Industry Update
Mary Lynn Mercado, PhD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-555-L04-P ; CME 1.00; RN 1.00

Join us for an interactive panel discussion with industry leaders who have simulated in-person, hybrid, and decentralized trial activities with target patients to optimize trial design and ensure a successful implementation.

Learning Objectives

Outline the steps to simulating the clinical trial experience with patients; Identify the benefits of conducting clinical trial simulations; Describe how industry leaders have optimized hybrid and decentralized trials through simulation activities.

Chair

Abbe Steel, MSc

Speaker

Panelist
Kimberley Kallsen, MPH

Panelist
Madeline Geday

Panelist
Sara Julian, MA, MLIS

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-562-L04-P ; CME 1.00; RN 1.00

This session discusses challenges and considerations in the design and implementation of real-world evidence studies including registry-based pragmatic trials and external control studies, based on real applications.

Learning Objectives

Demonstrate various designs of a real-world evidence study; Identify the challenges to plan and conduct a real-world evidence study; Discuss considerations for those challenges.

Chair

Yueqin Zhao, PhD

Speaker

Regulatory Considerations on Leveraging Real World Evidence
Di Zhang, PhD

DAPA-MI: World’s First Indication-Seeking Registry-Based Randomized Controlled Trial
Jingyu (Julia) Luan, PhD

The Use of a Real-World Data as a Hybrid Control in PAH
Brian Hennessy, MSc

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-599-L04-P ; CME 1.00; RN 1.00

The use of model-informed drug development (MIDD) has increasingly been incorporated into pediatric drug development programs. The ICH E11A guideline and the ICH MIDD discussion group will be used to open a discussion about different opportunities to use MIDD during drug development.

Learning Objectives

Describe current approaches to optimizing global drug development through quantitative methods such as model-informed drug development (MIDD) and pediatric extrapolation; Identify an update on the ICH E11A Pediatric Extrapolation guideline as well as an update from the ICH MIDD Discussion Group.

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Speaker

FDA Update
Lynne Yao, MD

EMA Update
Andrew Thomson, PhD, MA, MS

Industry Update
Nicolas Frey, PharmD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-618-L04-P ; CME 1.00; RN 1.00

This session will feature international regulators describing the options open for having a Complex Innovative Design agreed. The focus will be on the success of the recent FDA pilot programme, and the current options available through the EMA.

Learning Objectives

Describe the aspects of FDA Complex Innovative Design and be able to foresee how to apply them to their own products; Recognize global differences in the pathways available and the possibility to achieve global harmonisation on complex innovative designs.

Chair

Andrew Thomson, PhD, MA, MS

Speaker

Moderator
Benjamin Hofner, PhD

FDA Update
Dionne Price, PhD

Sponsor Perspective on Interacting with the FDA CID Program: A Case Study
Marius Thomas, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-631-L04-P ; CME 1.00; RN 1.00

Platform trials combine the advantages of multi-arm trials with the flexibility of classical drug development based on independent studies. We will highlight the main statistical issues and cover both the European regulatory and industry perspective.

Learning Objectives

Describe the main statistical challenges in platform trials; Discuss the role of clinical trial simulations when designing master protocols; Identify the key aspects when planning and analyzing platform trials.

Chair

Alex Sverdlov, PhD

Speaker

Master Protocols: Considerations from EU-PEARL and the European Regulatory Network
Benjamin Hofner, PhD

Challenges in the Execution of Platform Trials in the Pharmaceutical Industry and What we Have Learned from EU-PEARL and the COVID-19 Pandemic
Peter Mesenbrink, PhD

Academic Update
Martin Posch, PhD