Clinical Trials Innovation Regulation and Costs - Working Session - World Health Summit 2009 WS-435

     Related Videos
Clinical Trials part 3
Clinical Trials part 4
Clinical Trials part 1
Protocol in Clinical Trials 10 of 13
Who Participates in Clinical Trials? 2 of 8

     More from this user

     Related Groups


     More on Sciencestage.com


 
  • Video url:                           Embed code: 

  • WHS2009-Oct-17  status
    (0) (0 Votes)
    Views: (1266)   Date: (06-05-10)   Time: (00:00:39)
  • Description:

    Working Session

    Clinical Trials: Innovation, Regulation and Costs




    Co-Host: German Research Foundation

    Chairs: Jürgen Schölmerich | Vice President | German Research Foundation (Deutsche Forschungsgemeinschaft)

    Liselotte Højgaard | Professor & Director & Chair of the European Medical Research Council | Copenhagen

    University Hospital




    Outline: R&D productivity in the pharmaceutical industry as measured by bringing innovative therapeutics to market is at a low level. Clinical trials, the bedrock of pharmaceuticals R&D, have become the major time-consuming driver of costs and complexity.

    The clinical paradigm is suffering from its regulatory burden, especially from complexity of varying national standards. It is not

    prepared well to deal effectively with non-pharmacological therapeutics and advances such as personalized medicine and

    regenerative medicine. Risk aversiveness is limiting the potential for new designs and statistical methods. The full potential of

    patient stratification and use of biomarkers remains to be captured as well.

    Furthermore, incentivation of industry on diseases with large patient populations and investigator-/academia-driven clinical

    research under severe strain leaves many innovation opportunities untapped and, hence, public health needs unaddressed.

    Especially investigator-driven clinical research is suffering from limited funding, lack of capabilities and huge complexity to deal

    with (e.g., data sharing, intellectual property issues, regulatory burden).

    In summary, we see untapped opportunities for innovation and a worsening trend of more complex regulations and more

    complex protocols facing implementation challenges with too large patient populations. Academia, funding agencies, regulatory

    agencies, and industry can resolve this multi-factorial issue only jointly.

    This interactive working session will provide an insider’s view on the problem from the perspectives of investigators, funding

    agencies, industry, and regulatory agencies. The aspiration is to conclude with a strong call for action on how to improve clinical

    medical research in Europe and globally: how to limit the regulatory burden for national and multinational trials, how to optimize

    targets and patient selection for clinical trials and how to assure trials of optimal statistical power, how to increase funding to

    investigator-driven clinical trials, and how to capture benefits of scientific advances through encouraging new designs. This task

    calls for collaboration of all relevant stakeholders.




    11.00 Problem Statement

    Jürgen Schölmerich | Vice President | German Research Foundation (Deutsche Forschungsgemeinschaft)




    11.05 The Investigator’s Perspective

    Brian Feagan | Director of Robarts Clinical Trials | Robarts Research Institute

    Multiple issues should be considered in selecting patients for clinical trials. True experiments in humans must be conducted under optimal ethical and scientific conditions with patient safety being the ultimate consideration. Frequently tension exists between

    selecting patients that are most likely to respond to an intervention (efficacy) and assessment of the intervention’s benefit in the

    “real world” (effectiveness). Designers of clinical trials must make wise decisions regarding patient selection if meaningful results

    are to be obtained. Examples from recent clinical trials will be used to explore these issues.


    &nb

     Related Documents

     Related Wikipedia Results

     Related Pubmed Results

     Related Nature.com Results

     Related on Youtube Results
  • What Does A Clinical Informationist Get Paid?
    What Does A Clinical Informationist Get Paid? From: Yui Ilp Views: 0 0 ratings Time: 01:29 More in Howto & Style
  • New Clinical Veterinary Refractometer
    New Clinical Veterinary Refractometer New Clinical Veterinary Refractometer click - http://bitIIy.com/1m16j5t This New Clinical Veterinary Refractometer is totally cheered all around. I would exceedingly propose it to anybody... From: Theresa Watson Views: 0 0 ratings Time: 01:32 More in Education
  • Improving Data Collection in Clinical Trials with TeleDiary™ for Smartphones & Tablets
    Improving Data Collection in Clinical Trials with TeleDiary™ for Smartphones & Tablets IVR Clinical Concepts Inc. introduces IWRS TeleDiary™ which now improves access and data entry not only by touch-tone telephone (IVRS), but also on most internet-connected smartphones and... From: IVR Clinical Concepts Views: 0 0 ratings Time: 02:07 More in Science & Technology
  • Berkshire West Clinical Commissioning Groups (CCGs) Connected Care
    Berkshire West Clinical Commissioning Groups (CCGs) Connected Care Connected Care is an initiative where local medical professionals can (with the patient's permission) read an accurate and up-to-date view of patient data directly from the from the original... From: BerkshireWestCCGs Views: 0 0 ratings Time: 02:34 More in Nonprofits & Activism
  • Dr. Marilyn Innes: Does high sensitivity troponin improve clinical outcomes in ACS?
    Dr. Marilyn Innes: Does high sensitivity troponin improve clinical outcomes in ACS? In this Journal Club, Dr. Marilyn Innes takes a critical look at a JAMA paper on high sensitivity troponins and their impact on clinical outcomes. This study takes on the question: Does lowering... From: EmergencyLondon Views: 1 0 ratings Time: 19:02 More in Education
  • BEH2012 - Scenario for Clinical Portfolio
    BEH2012 - Scenario for Clinical Portfolio From: Andrew Orellana Views: 0 0 ratings Time: 13:23 More in Music
  • ArmeoSpring Clinical Video Manual Training KK 0810 Original 5370
    ArmeoSpring Clinical Video Manual Training KK 0810 Original 5370 From: Katalin Timea Views: 0 0 ratings Time: 00:38 More in People & Blogs
  • **v3** SLAM Clinical #2AC24
    **v3** SLAM Clinical #2AC24 From: BarfordProductions Views: 0 0 ratings Time: 06:32 More in Science & Technology
  • Tribal girls exploited by Pharma companies, die in clinical trials - Tv9
    Tribal girls exploited by Pharma companies, die in clinical trials - Tv9 Tribal girls exploited by Pharma companies, die in clinical trials - Tv9 ▻ Download Tv9 Android App: http://goo.gl/T1ZHNJ ▻ Subscribe to Tv9 Telugu: http://goo.gl/x4OEU8 ▻ Like us on... From: Tv9 Telugu Views: 53 0 ratings Time: 07:40 More in News & Politics
  • Clinical Practice Guideline Recommendations: Autism Spectrum Disorder
    Clinical Practice Guideline Recommendations: Autism Spectrum Disorder La Trobe University, final year speech pathology student Speaker 3, critique of New Zealand Clinical Practice Guideline. From: Jenan Kantar Views: 7 0 ratings Time: 05:56 More in People & Blogs
  • clinical sas programming online demo
    clinical sas programming online demo sas clinical,sas sdtm,sas adam,sas macros,sas functi online training contact me on mangasubbu@gmail.com +918686264989. From: Subbu Naidu Views: 4 0 ratings Time: 13:02 More in People & Blogs
  • Mesothelioma clinical What is the mesotheliom 2014a clinical
    Mesothelioma clinical What is the mesotheliom 2014a clinical From: judy ballad Views: 0 0 ratings Time: 02:28 More in Science & Technology
  • Clinical Practice Guideline Recommendations: Autism Spectrum Disorder
    Clinical Practice Guideline Recommendations: Autism Spectrum Disorder Speaker 4 La Trobe University, Final Year Speech Pathology. From: Emily Green Views: 4 0 ratings Time: 04:20 More in People & Blogs
  • Clinical Evaluation of Patients for Hyperbaric Oxygen
    Clinical Evaluation of Patients for Hyperbaric Oxygen The ability to appropriately select and evaluate patients for hyperbaric oxygen therapy is a cornerstone of this field of medicine. Performed purposefully and effectively it assures a good... From: Frans J Cronje Views: 1 0 ratings Time: 34:25 More in Education
  • Clinical Evaluation of Language Fundamentals- Preschool 2
    Clinical Evaluation of Language Fundamentals- Preschool 2 From: Janki Boghara Views: 1 0 ratings Time: 07:34 More in People & Blogs
  • Clinical IV
    Clinical IV From: Morgan Carr Views: 1 0 ratings Time: 06:05 More in People & Blogs
  • Clinical Decision Support Systems
    Clinical Decision Support Systems I DO NOT OWN ANY OF THE PICTURES. From: Emily Bullard Views: 2 0 ratings Time: 03:31 More in People & Blogs
  • Working eLab Clinical Labs Software Crack No Survey
    Working eLab Clinical Labs Software Crack No Survey Download Now: http://bit.ly/1vD22pT [Free] Working 100%, New update 2014 , Free Download Now Working eLab Clinical Labs Software Crack No Survey No survey, No password *Ignore Tags*... From: Tim Hernandez Views: 0 0 ratings Time: 00:44 More in Gaming
  • The MAN Who MISTOOK His WIFE for a HAT and Other Clinical TALES By Oliver Sacks AUDIOBOOK
    The MAN Who MISTOOK His WIFE for a HAT and Other Clinical TALES By Oliver Sacks AUDIOBOOK From: donald's new aUdiobooks Views: 0 0 ratings Time: 09:19:15 More in People & Blogs
  • Changes in Testing and Clinical Methods
    Changes in Testing and Clinical Methods John Saltzman, MD, Director of Endoscopy, Brigham and Women's Hospital, shares his experiences and thoughts on the variety of fascinating topics discussed at the 2014 ACG Annual Meeting in... From: HCPLiveTV Views: 0 0 ratings Time: 06:57 More in Science & Technology
  • Women’s Guild Simulation Center for Advanced Clinical Skills
    Women’s Guild Simulation Center for Advanced Clinical Skills The Women's Guild Simulation Center for Advanced Clinical Skills is the ultimate training environment — one where surgeons, physicians, nurses, and allied healthcare professionals can master... From: SupportCedarsSinai Views: 3 0 ratings Time: 04:57 More in Nonprofits & Activism
  • Clinical Experience Video- Yliana Ruiz
    Clinical Experience Video- Yliana Ruiz From: Yliana Ruiz Views: 2 0 ratings Time: 15:03 More in People & Blogs
  • Herston Imaging Research Faciltiy welcomes 3 new clinical scanners
    Herston Imaging Research Faciltiy welcomes 3 new clinical scanners Herston Imaging Research Faciltiy welcomes the installation of 3 new clinical scanners. From: Faculty of Medicine + Biomedical Sciences Views: 0 0 ratings Time: 00:31 More in People & Blogs
  • Clinical Kinesiology I
    Clinical Kinesiology I From: McKenzie Karelus Views: 3 0 ratings Time: 01:30:04 More in People & Blogs
  • Clinical Kinesiology II
    Clinical Kinesiology II Neuro Rehab Lab SCI video. From: McKenzie Karelus Views: 2 0 ratings Time: 52:44 More in People & Blogs

  •      Related Answers Results



























       

      Powered free by PHPmotion