Free Live Webinars - Seminars  

IDDI Bay Area Complimentary Seminar 

SMARTER CLINICAL TRIALS - GAINING TIME WITHOUT INCREASING RISK

March 8, 2012, from 7:00 am to 1:30 pm  Menlo Park, CA

REGISTER HERE

 

At the current pace of new drug development, there is a definite need for speeding up clinical trials, as well as making them more efficient and better targeted at the right patient populations. The purpose of this Seminar is to outline recent developments in trial design and statistical methodology that will enable participants to address these challenges effectively. The four sessions will mix of statistical theory and application to actual trials, including a discussion of success and failure stories.

  • FORMAT

A half-day seminar with 4x45 minute talks and 2x30 minute Q&A sessions. The speakers will remain available for further discussions in the afternoon.

  • OUTLINE
  1. Session 1 : Risk-free data monitoring: group sequential designs and interim analyses
  2. Session 2 : Adapting trials: hype vs. substance in adaptive trial designs
  3. Session 3 : Independent Monitoring Committees: key players in the conduct of trials
  4. Session 4 : Towards personalized medicine: the need for better endpoints and biomarkers
  • SCHEDULE

  • 7:00 - 8:00 am : Buffet breakfast
  • 8:00 - 8:45 am : Session 1 - Jay Herson
  • 8:45 - 9:30 am : Session 2 - Marc Buyse
  • 9:30 - 10:00 am : Q&A
  • 10:00 - 10:30 am : Coffee break
  • 10:30 - 11:15 am : Session 3 - Jay Herson
  • 11:15 - 12:00 pm : Session 4 - Marc Buyse
  • 12:00 - 12:30 pm : Q&A
  • 12:30 - 1:30 pm : Buffet lunch and main meeting adjournment
  • 1:30 - 3:30 pm :  Speakers available for individual consultations

  • SPEAKERS

  • Marc Buyse, ScD, IDDI (Houston, TX) and Hasselt University (Belgium)
  • Jay Herson, PhD, Johns Hopkins Bloomberg School of Public Health (Baltimore, MD)

  • VENUE

    Menlo Room, Stanford Park Hotel, 100 El Camino Real, Menlo Park, CA 94025, www.stanfordparkhotel.com

  • GUESTROOM INFORMATION AND RESERVATION

    Complete hotel information available here. 

  • CONTACT INFORMATION

    Paul Milne, paul.milne@iddi.com Tel: +1 281 820 7850


PAST WEBINARS:

TOPICS:

  • On Thursday January 19, 2012, IDDI organized a webinar on Designs of Non-Inferiority and Biosimilar Clinical Trials with more than 65 registrants.

    - Contents of the 60 min recording of the webinar:

    This webinar presented key concepts and current examples regarding the Designs of Non-Inferiority and Biosimilar Clinical Trials.
    The objectives of this webinar were:
    - To understand the challenges of biosimilar clinical development
    - To be familiar with the regulatory environment for biosimilars in Europe and the USA.
    - To be able to discuss trial designs for equivalence and non-inferiority

  • On Tuesday November 15, 2011, IDDI organized a webinar on Achieving Efficiency in Clinical Data Collection with more than 45 registrants.

    - Contents of the recording of the webinar (1st please right click sound icon on 'Open Link', then click on Slide show):
    The speaker described  the options to consider in clinical data collection systems and will reveal hints and tips while praising the adoption of standards.
    This webinar was intended to cover the key aspects of clinical data collection that contribute to operational efficiency. Examples illustrated the concepts described.

  • On August 18, 2011, IDDI organized a joint Seminar/webinar at Cell Therapeutics Inc. Seattle, US on Design and Analysis of Phase II trials in Oncology with more than 80 registrants.

    - Contents:
    This webinar  presented key concepts and current examples regarding the design and analysis of phase II trials in oncology. Aims, methods and limitations of phase II trials in oncology, including the important issues of study design, choice of endpoints, the need for randomization, and correct interpretation and decisions in the overall drug-development process.
  • On May, 26, 2011, IDDI organized itd 5th free live webinar on Operational Aspects of Data Monitoring Committees with more than 120 registrants

    - Contents of the 60 min recording of the webinar :

    The webinar explored best practices that have emerged during this time. The emphasis was on the safety monitoring responsibilities of data monitoring committees in the pharma industry. The webinar showed how practices and issues vary over these three strata. Organizational issues, meetings, clinical issues, useful statistical methods, biases and pitfalls, DMC decisions and emerging issues including adaptive designs and cost control wre covered. The issues were illustrated by actual behind-the-scenes scenarios providing rare look at DMC practices.

  • On March, 31, 2011 IDDI organized its fourth free live webinar on Design and Analysis of Phase II trials in Oncology with more than 160 registrants

    - Contents of the 60 min recording of the webinar :

    This webinar presented key concepts and current examples regarding the design and analysis of phase II trials in oncology. Aims, methods and limitations of phase II trials in oncology, including the important issues of study design, choice of endpoints, the need for randomization, and correct interpretation and decisions in the overall drug-development process.
  • On December 9, 2010 IDDI organized its third free live webinar on Biomarker-based Clinical Trials Designs with more than 150 registrants

    -Contents of the 60 min recording of the webinar :

    The Webinar focused on the biomarker-based designs of clinical trials.
    - Review of the recently proposed-designs, including adaptive designs, and discuss the main issues related to their application. Their ability to validate the biomarker and/or to establish the effect of an experimental therapy in patient populations defined by the presence or absence of the biomarker is analyzed.
    - Focus on biomarkers that modify the prognosis of individual patients ("prognostic" biomarkers) and biomarkers that predict how individual patients will respond to specific treatments ("predictive" biomarkers, also called "effect modifiers").
    All discussed methods and concepts were  illustrated by using real-life examples from oncology. 
     
  • On September 3, 2010 IDDI organized its second free live webinar on Development and Validation of Clinically Useful Gene Signatures  with more than 120 registrants.

    - Contents of the 60 min recording of the webinar:

    This webinar reviewed statistical issues in the development and validation of gene signatures for breast cancer. 
    Using three recently developed signatures (MammaPrint®, Oncotype DX® and MapQuant DxTM), the speakers discussed the role of gene selection, classification methods and cluster analysis in signature development, as well as the need for internal and external validation of the signatures.
    - The speakers were Dr Marc Buyse, Chairman IDDI and Dr. Stefan Michiels, Breast Cancer Translational Unit, Institut Jules Bordet and Senior Biostatistical Consultant IDDI. 
     
  • On June 22, 2010 IDDI organized its first free live webinar on Statistical Validation of Biomarkers with more than 250 registrants.

       - Contents of the 60 min recording of the webinar: 

       This webinar reviewed :
       - The use of biomarkers and surrogate endpoints in drug development. 
       - The concepts of prognostic/predictive biomarkers and surrogate endpoints. 
       - The Statistical techniques, criteria and study designs appropriate for  the clinical  validation of  these various types of biomarkers.
       - The speakers were Dr Marc Buyse, Chairman IDDI and Prof Tomasz Burzykowski, VP Research IDDI.