Archives: Agenda

SMOs: The Hidden Engine of Japan’s Clinical Trials in Changing Times

Japan’s clinical research landscape offers a unique model, characterized by well-established processes such as the Site Management Organization (SMO) system, which plays a critical role in site selection and accelerating patient recruitment. Over the past five years, Japan has made significant strides in streamlining its regulatory pathways, with median new drug approval timelines now approaching parity with those of the U.S. FDA.

In this session, as Japan’s leading CRO and SMO, we will provide a quick overview of recent PMDA regulatory updates and deliver an in-depth view of how SMOs operate within Japan’s clinical trial ecosystem. Attendees will gain valuable insights into a proven model that enhances trial efficiency and support global development strategies.

Running a successful trial for rare cancers: best practice for recruitment and engagement

·       Using the DETERMINE national platform precision medicine trial for rare cancer as a case study to share lessons learned and key factors to consider when  it comes to patients in a rare cancer trial

·       Collaborating with patient advocacy groups to facilitate recruitment, retention and patient engagement

·       Patient identification: how to find patients who are eligible to participate in your rare disease trial

·       Working with the Experimental Cancer Medicine Centres network of sites to recruit and refer patients nationally

Patient involvement and engagement, how well are you doing this?

  • Discussing the collaboration that must exist between all parties (patients, coordinators, doctors) in order to have a successful trial
  • Importance of good communication to the patients and how this can streamline trial timelines
  • Exploring how patients could, and should, be influencing decisions and the R&D process before study start-up

Why are eCOA studies still so hard?

Despite decades of experience implementing electronic clinical outcome assessments (eCOAs) in clinical trials, we continue to grapple with the same operational challenges during set-up and implementation. They’re solvable – yet they persist. Why?

 

This presentation will discuss key barriers that continue to slow progress, including:

•            Licensing and copyright holder review processes

•            Perceived need for screenshots for IRB/EC submission

•            Fragmented stakeholder collaboration and lack of true partnership

•            Unbalanced expectations – electronic vs paper, BYOD vs provisioned

•            Misconceptions around regulatory expectations

 

By addressing these challenges head-on, and fostering genuine collaboration, we can solve them if we truly want to gain efficiencies and optimisations in clinical trial set-up.

AI-Powered Trials: Transforming Design and Execution

Designing and running clinical trials is becoming more complex, with increasingly challenging conditions, evolving regulations, and growing demands for speed and cost efficiency. With rich patient and site-level data from over 35,000 historical and ongoing studies, Medidata’s AI-driven solutions transform study design and execution—enabling teams to make better, faster decisions and proactively mitigate risks across the study lifecycle.