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Envisioning a Transformed Clinical Trials Enterprise in the United States Establishing an Agenda for 2020: Workshop Summary (2012) / Chapter Skim
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Appendix G: Discussion Paper: Developing a Clinical Trials Infrastructure
Pages 193-202

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From page 193...
... Nonetheless, over time, clinical trials in the United States have become too expensive, difficult to enroll, inefficient to implement, and ineffective to support the development of new medical products using modern evidentiary standards. The nation's capacity for conducting clinical trials is also inadequate to provide the evidence needed for rational clinical practice.
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From page 194...
... Development of an explicit and transparent national clinical trials infrastructure may potentially increase access to clinical trials for multiple stakeholders. For example, training and recruitment of less-experienced investigators who practice in settings that are relevant to the clinical questions being addressed may improve the applicability of the results to the
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From page 195...
... Development of a clinical trials infrastructure can only be a component of the solution to the issues highlighted, but the potential of key initiatives to support or catalyze change in the clinical trials capacity and quality in the United States is worth considering and is the topic of this discussion paper. It is also worth considering that while electronic health records, standard nomenclature, and data standards clearly are critical to an efficient and scalable infrastructure, these efforts remain immature with respect to broad implementation in the U.S.
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From page 196...
... • C ommunication of results (publication) • R egistration of clinical trials and results on ClinicalTrials.gov POTENTIAL AREAS THAT A NATIONAL CLINICAL TRIALS INFRASTRUCTURE COULD ADDRESS Investigator Training • tandardized core content and the availability of Continuing Medical S Education (CME)
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From page 197...
... • evelopment of novel approaches to clinical trial development. For exam D ple, clinical questions or concepts could be placed in an online site where potential investigators or sponsors could propose potential trials.
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From page 198...
... A flexible infrastructure to provide clinical research coordination and administrative support for clinical trials should be considered along with many of the similar training and certification elements for investigators. Some of the areas in which support is needed for the various components of a clinical trial include the following: • tandardized contracts are key to accelerating the contracting and S subcontracting in clinical trials, as contracting typically causes the greatest delays in start-up.
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From page 199...
... • ntegration of electronic health records with clinical trial databases would I be another means of improving clinical trial recruitment and also developing realistic estimates of potential patients available for specific trials. Patients could be offered an opt-in approach to be
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From page 200...
... When pos sible, harmonized data standards for use in clinical research should be mapped to electronic health records to facilitate screening. • evelopment of a centralized electronic tool for notifying investigators, D regulators, and IRBs of AEs, "Dear Investigator" letters, and clinical trial amendments.
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From page 201...
... WHAT WOULD BE REQUIRED? One model for a clinical trials infrastructure involves organizing disease-specific networks that include medical practitioners in the com munity.
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From page 202...
... A "virtual coordinator" could remotely support several community practice sites in a clinical trial network. Another approach is a "hub and spoke" system in which a larger medical center would partner with community health care providers on designing and implementing clinical trials.
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Key Terms

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  • transformed clinical
  • clinical practice

  • trial opportunities
  • trial recruitment
  • health records
  • electronic health
  • practice guidelines

  • informed consent
  • patient access
  • quality improvement
  • conducting clinical
  • clinical questions

  • national clinical
  • trial agreements
  • trial information
  • trials conducted
  • discussion paper

  • investigator training
  • academic centers
  • electronic medical
  • worth considering
  • medical practitioners

  • data standards
  • efficient clinical
  • various clinical
  • review clinical
  • reduce clinical


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