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Therapeutic Innovation & Regulatory Science

Therapeutic Innovation & Regulatory Science

The scope of Therapeutic Innovation & Regulatory Science reaches beyond pharmaceutical research and development to include innovations in drugs, devices, and diagnostics, as well as global regulatory issues.

Virtual Journal Club

Clinical Trials: Rethinking How We Ensure Quality

TIRSDIA’s Virtual Journal Club (VJC) is an opportunity for live discussion on important topics that have appeared in DIA’s peer-reviewed journal. VJCs are held throughout the year on various journal articles and are free to attend for both DIA members and non-members alike.

Register for an upcoming VJC and receive free access to the applicable journal article for the month in which it is scheduled.  Join the scheduled live discussion via teleconference to hear a brief presentation of the article and have an opportunity to ask questions about the article and participate in discussion with other industry colleagues and experts world-wide.



Upcoming VJCs:

TITLE: Clinical Trials: Rethinking How We Ensure Quality

DATE: July 22nd 10:00 – 11:30 AM ET

Concern is widespread that clinical trials are becoming increasingly costly and burdensome to conduct. The challenge is to find efficient and practical means of ensuring that trials provide conclusive answers while safeguarding the well-being of the patients who take part in them. Monitoring—often via site visits, post hoc data checks, and site auditing—is used to assess compliance with the protocol to ensure the safety of patients and the reliability of results. For trials that enroll large numbers of patients in multiple sites and multiple countries, the logistical and financial implications of frequent monitoring visits are daunting and are prohibitive for trials based in community or other routine health care settings. Furthermore, auditing a trial after patients are enrolled and data have been collected may not be the most efficient or effective means to ensure optimal human subject protection and trial quality. Accordingly, many in the clinical trial enterprise have expressed concerns about whether the current model for monitoring trials is effective and should be sustained.

  • Martin J. Landray, PhD, FRCP
    Reader in Epidemiology, Clinical Trial Service Unit
    University of Oxford, UK
  • Background to CTTI
    Judith M. Kramer, MD, MS
    Professor of Medicine
    Duke University Medical Center
  • Key Principles
    Martin J. Landray, PhD, FRCP
    Reader in Epidemiology, Clinical Trial Service Unit
    University of Oxford, UK
  • Industry Perspective
    Briggs W. Morrison, MD
    Head, Global Medicines Department
  • Regulatory Perspective
    Anne Meeker-O’Connell, MS
    Acting Associate Director, Risk Science, Intelligence and Prioritization,
    Office of Scientific Investigators, Office of Compliance
Registration opens July 1st