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Transforming Clinical Research in the United States Challenges and Opportunities: Workshop Summary (2010) / Chapter Skim
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2 The State of Clinical Research in the United States: An Overview
Pages 5-13

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From page 5...
... Chapters 4, 5, 6, and 7, respectively, summarize workshop presentations and discussions regarding the strengths and weaknesses of various clinical trial models in the above four disease areas and the usefulness of clinical trial results for informing clinical practice in each area. Chapter 8 describes efforts currently under way to improve clinical trials, summarizes the breakout session discussions regarding strategies for advancing clinical research in the identified disease areas, and presents a vision for a sustainable clinical trials infrastructure in the United States.
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From page 7...
... Clinical trials, a type of clinical research, are one of the most robust sources of this knowledge. A number of workshop speakers from many backgrounds -- clinical investigators, research sponsors, practitioners, and patients -- expressed the view that the current clinical research enterprise1 in the United States is unable to produce the high-quality, timely, and actionable evidence needed to support a learning health care system.
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From page 8...
... . Research commissioned for the workshop from Ronald Krall, former Chief Medical Officer, GlaxoSmithKline, is then presented, addressing tools available for assessing clinical research in the United States; volume and type of clinical trials conducted; the clinical investigator workforce; and the overall capacity of the clinical research enterprise.
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From page 9...
... TOOLS FOR ASSESSING CLINICAL RESEARCH IN THE UNITED STATES2 Krall obtained information on the current state of clinical trials in the United States from various public and private sources. A key source was data on submissions to clinicaltrials.gov, a federally sponsored, publicly available registry of clinical trials.
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From page 10...
... of 2007 created a legal requirement for the registration of trials of drugs, biologics, and devices, generating a modest increase in the registration of 18,000 16,000 14,000 12,000 10,000 Trials 8,000 6,000 4,000 2,000 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 Efficacy trials for "serious and life-threatening" conditions and interventions regulated by FDA FDA Modernization Act of 1997 Registration required for publication Legal requirement for International Committee registration of trials of Medical Journal Editors FDA Amendments Act of 2007 FIGURE 2-1 Timeline reflecting the number of clinical trials registered on clinicaltrials.gov and regulatory changes affecting the database registration from 2001 to 2009. SOURCE: Krall, 2009.
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From page 11...
... Yet while clinicaltrials.gov is not without limitations, Krall suggested that its creation is undoubtedly a positive step toward developing a clearer picture of the state of clinical research in the United States. VOLUME AND TYPE OF CLINICAL TRIALS CONDUCTED In RCTs, investigators control which participants receive the study treatment by assigning them at random to a particular experimental study group.
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From page 12...
... An analysis of clinical research by phase of experimental clinical trials can indicate the degree to which innovative new therapies are being developed and tested. It takes 10−15 years for a typical drug to be developed successfully from discovery to registration with the FDA.
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From page 13...
... Reprinted with permission from Ronald Krall 2009. Figure 2-2 R01728 1 pie char ts are uneditable bitmapped (left and right separate)
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Key Terms

  • clinical trial
  • research networks
  • ongoing clinical
  • clinical practice
  • iii trials

  • learning health
  • phase iii
  • conducting clinical
  • current clinical
  • assessing clinical

  • clinical sites
  • research stakeholders
  • pharmaceutical companies
  • tufts center
  • trials conducted

  • individual pharmaceutical
  • drug development
  • investigator workforce
  • modernization act
  • discussions regarding

  • informing clinical
  • various clinical
  • clinical investigator
  • experimental clinical
  • supported clinical

  • interventional clinical
  • improve clinical
  • ducting clinical
  • include clinical
  • advancing clinical


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