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

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  • 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

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