Symposium 10: Hot Topics: Decentralized Clinical Trials & Clinical Pharmacology, A Joint ACCP & KSCPT Symposium

Monday, September 9, 2024

3:30 PM – 5:00 PM ET

Location:Grand Ballroom D

CE: 1.5

Co-Chair & Faculty(s)

Myong-Jin Kim, PharmD (she/her/hers)

Slides
Kyung-Sang Yu, MD, PhD

Professor
Seoul National Univ College of Medicine & Hosp

Faculty(s)

Seol Ju Moon, MD, PhD (she/her/hers)

Assistant Professor
Dept of Pharmacology
Jeonbuk National Univ Hosp
Leonard Sacks, MD (he/him/his)

Associate Director, Office of Medical Policy
Ctr for Drug Evaluation & Research
US Food & Drug Administration

Target Audience:

The target audience for this Symposium is MDs, PharmDs and PhDs interested in clinical trials and clinical pharmacology studies.

Description:

Decentralized clinical trials (DCTs) can play an important role in addressing global health needs. Regulatory agencies worldwide are adapting to this evolving landscape of clinical trials. For example, the US Food & Drug Administration has taken additional steps to support the use of DCTs by releasing a guidance that provides recommendations regarding the implementation of DCTs to advance medical product development and research. Rapid growth in the Asia-Pacific clinical research market has created strong opportunities for utilizing DCAs in the region. Korea is at the forefront of integrating DCTs by incorporating global DCT technologies and practices. In this joint ACCP-KSCPT Symposium, we will explore the opportunities and complexities of DCTs from a global perspective by sharing the key considerations when conducting DCTs.

Goals & Objectives:

Following the completion of this activity, the learner will be able to:

Describe the role of DCTs, an evolving landscape of clinical trials, in addressing global health needs;
Discuss the utility of DCT elements in clinical research and integrate DCT technologies and practices to make clinical trials more inclusive;
Explore the opportunities and complexities of DCTs from a global perspective by sharing the key considerations when conducting DCTs.

Presentations:

Global Health & Decentralized Clinical Trials
Co-Chair & Faculty: Myong-Jin Kim, PharmD (she/her/hers)
Decentralized Clinical Trials: Bringing Trial-related Activities to the Patient
Faculty: Leonard V. Sacks, MD (he/him/his) – US Food & Drug Administration
Investigator's Perspective on Decentralized Clinical Trials
Co-Chair & Faculty: Kyung-Sang Yu, MD, PhD – Seoul National Univ College of Medicine & Hosp
Management of Medication & Laboratory Specimens in Decentralized Clinical Trials: Mobile Application & Contactless Regional Shipping
Faculty: Seol Ju Moon, MD, PhD (she/her/hers) – Jeonbuk National Univ Hosp
Discussion, Questions & Answers, Learner Feedback & Evaluations