Applied Clinical Trials Digital Edition - December 2015/January 2016

In this Q&A, James Cheong, senior vice president of Asia Pacific at Precision for Medicine, discusses why outdated perceptions of APAC sites persist among smaller biotechs, how China’s regulatory reforms have reshaped Phase III startup timelines, and what first-time sponsors need to get right in the region.

In today’s ACT Brief, we examine three priorities for first-time APAC sponsors, how continuous glucose monitoring should be used in diabetes trials, and why FDA is requiring a new eye-related warning across GLP-1 medications.

In this video interview, James Cheong, senior vice president of Asia Pacific at Precision for Medicine, shares three priorities for first-time APAC sponsors: aligning with marketing authorization plans, selecting the right sites, and choosing a CRO with regional experience and KOL networks.

FDA and EMA expectations shape how sponsors use CGM in diabetes trials, from blinding and study-provisioned devices to data integrity and ePRO integration.

In today’s ACT Brief, we examine why APAC is attractive for global Phase III programs, how clinical research professionals can turn a failed pivotal trial into a redesigned success, and how FDA approved Sunharbo to reduce recurrent stroke risk.

A pivotal trial that missed its primary endpoint became the basis for a successful redesign after the team used the data to define the high-risk patients most likely to benefit, showing that setbacks can strengthen development when organizations interrogate the evidence rather than abandon it.

In this video interview, James Cheong, senior vice president of Asia Pacific at Precision for Medicine, outlines why faster recruitment, local data requirements for registration, and lower costs make APAC attractive for global Phase III programs.

In today’s ACT Brief, we examine how China’s trial startup timelines compare with those in the US and Europe, whether AI-drafted clinical study reports speed drug development, and how Bimzelx compared with Skyrizi in psoriatic arthritis.