CommentaryClinical Trials

A Virtual National Laboratory for Reengineering Clinical Translational Science

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Science Translational Medicine  25 Jan 2012:
Vol. 4, Issue 118, pp. 118cm2
DOI: 10.1126/scitranslmed.3002951


  • Fig. 1

    High-level process flow map for opening a cancer clinical trial. There are four components in the process: initial preparation of the trial documents, approval processes for the trial, estimation of the costs of the trial, and final preparation of the approved and budgeted clinical trial protocol. For a more comprehensive view of the process flow map, see Symbols are as follows: box, process; diamond, decision; arrow, flow; circular arrows, loop or repeat steps. CRC, clinical research center; CTO, clinical trials office; FDA, Food and Drug Administration; N, no; PI, principal investigator; SRC, scientific review committee; Y, yes.



  • Table 1

    A sampling of CTSA site participation in Consortium process improvement strategies. This table lists challenges in clinical research management and the methods used by the CTSA Consortium (n = 60 sites) to address them.

    Identified challenges in clinical research managementStrategic intervention teamInterventionCTSA participation [No. of sites/total sites at time of intervention (%)]
    Lack of institutional commitment to efficiencyAppoint champions of changeImplement process improvement as guided by Consortium-wide studies, data, analysis, and recommendations51/55 (93%)
    Lengthy protocol processingProtocol Review CommitteeTwo Consortium-wide studies of protocol processing times50/55 (91%)
    Lengthy contract negotiationContract Review CommitteeTwo Consortium-wide studies of contract negotiation times42/46 (91%)
    Multisite IRB review of identical multisite clinical protocolsReliance IRB Agreements GroupsRegional agreements member CTSA site (number of institutions) that signed agreement: Harvard (10), University of Wisconsin, Medical College of Wisconsin (Milwaukee) (5), The University of Texas (15), The University of California (4), Case Western (4), University of Rochester (16), University of Colorado (5), other sites (2, 3)>20/60 (>33%)
    Delayed study start-up, inadequate enrollment of study participantsRecruitment GroupRecruitment model demonstrations: Rockefeller University, Washington University, Ohio State University, University of California–San Francisco, Virginia Commonwealth UniversityN/A
    Web-based recruitmentResearchMatch54/55 (98%)
    Delayed completion of studiesFeasibility GroupPending
    Research participant surveyA quality and research experience assessment13/38 (34%)

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