DIA 2025 Global Annual Meeting

Component Type: Forum
Level: Intermediate

This session will share healthcare professionals' (HCP) perceptions about participating in clinical research as non-investigators. We will address the challenges and opportunities for HCP participation, aligned to the FDA guidance on DCTs as well as Point of Care Trials.

Learning Objectives

Analyze healthcare professionals' (HCPs) perceptions, both positive and negative, about participating in clinical research; Evaluate which routine care trial assessments HCPs might conduct as part of trials and assess study fit; Identify key strategies to engage HCPs in trial participation without requiring them to become investigators; Share resources to assist teams in navigating regulatory documentation.

Chair

Jane Myles, MSc

Component Type: Session
Level: Intermediate

Partnerships are crucial to overcoming the challenges clinical trials face in Africa. We will present the current landscape, provide key pointers on navigating it, and share case studies demonstrating the key importance of involving Africa in trials.

Learning Objectives

Recognize the importance of including Africa in clinical trials; Identify challenges of conducting clinical trials in Africa; Apply knowledge to successfully conduct global clinical trials in Africa.

Chair

Lynda Mante

Component Type: Forum
Level: Intermediate

This highlights the challenges of using real-world data (RWD) for patient referral in clinical trials, focusing on issues like data variability, lack of investigator training, and insufficient incentives. It proposes strategic solutions to overcome these barriers.

Learning Objectives

Identify innovative strategies for patient recruitment using RWD referrals that challenge existing practices; Propose new methods for integrating naïve sites into the clinical trial process to expand participation; Evaluate the potential impact of broader patient inclusion on clinical trial outcomes.

Chair

Sanghita Bhattacharya, PhD

Speaker

Patient Referral: Is It Hope or Hype?
Barbara Isquith Arone, MS

Patient Referral: Is It Hope or Hype?
Karen Correa, PhD

Patient Referral: Is It Hope or Hype?
Irfan A. Khan, MD

Component Type: Forum
Level: Advanced

The session will describe informed consent in research participants with cognitive decline, discussing behavioral cues and consent/assent requirements for ethical practices when participants lose the ability to provide informed consent during a study

Learning Objectives

Understand the ethical and operational challenges of engaging participants with cognitive impairment; Describe ethical options for retaining participants with cognitive impairment in clinical trials; Review best practices for informed consent/ caregiver consent/participant assent when the ability to give consent is lost during the course of a trial

Chair

Karla Childers, MS

Component Type: Session
Level: Intermediate

Japan's regulatory authorities have enacted various measures to strengthen drug R&D and accelerate clinical development, particularly for regenerative medicine, pediatric, and orphan drugs, offering great prospects for biopharma/ biotech companies.

Learning Objectives

Examine PMDA's efforts to address Japan's drug lag and promote an accelerated clinical development environment; Evaluate the trial landscape and analyze the challenges in developing Regenerative Medicine, Orphan, and Pediatric drugs in Japan; Develop strategies for Japan to engage in multi-regional trials, considering the unique aspects of conducting clinical studies in the country.

Chair

Edward C. Ian, MBA

Component Type: Session
Level: Intermediate

This session will be based on a recent Tufts Center for the Study of Drug Development (CSDD) study that examined lung cancer studies to examine how and whether exclusion criteria could hinder the participation of racial minority patients. The panel will feature experts from the Tufts CSDD tea

Learning Objectives

Identify areas within a study protocol where bias can manifest to adversely exclude marginalized patient populations; Discuss approaches, strategies, and lessons-learned to help de-bias protocol design.

Chair

Jennifer Kim, PhD

Speaker

Overcoming Re-Design Efforts of Study Protocols
Kim Ribeiro, MS