Table 2.

EVOLVE collaborative network and responsibilitiesa

EntityResponsibilities
Amgen Inc. (study sponsor)Develop operational strategy, oversee global study execution, and promote alignment among all regions; monitoring and site management in European Union and Australia
Executive CommitteeOversee the design, execution, and analysis of the study in conjunction with Amgen; report and communicate the study results in conjunction with Amgen
Clinical Endpoint Committee (Duke Clinical Research Institute)Adjudicate study end points in an unbiased and consistent manner according to prespecified end point criteria
Data Monitoring CommitteeMonitor accumulating efficacy and safety data; make recommendations to the Executive Committee and Amgen regarding study conduct
Independent Biostatistics Group (Frontier Science and Technology Research Foundation)Support the study's Data Monitoring Committee through independent analyses of safety and efficacy study data
Clinical Research Organization (Quintiles Inc.)Monitoring and site management in United States, Canada, Latin America, and Russia; data management and end point packages processing
Investigative sitesRecruitment of participants and ethical conduct of the study in accordance with the protocol and all applicable guidelines
Central laboratory (Covance Central Laboratory)Specimen management; analysis and storage of laboratory samples
Interactive Voice Response System (ICOPhone)Patient randomization, drug dispensation, and assignment of investigational product dosing and drug supply management
Dialysis Service OrganizationsFacilitate site identification, contract approvals, and patient enrollment
  • a EVOLVE, Evaluation of Cinacalcet Therapy to Lower Cardiovascular Events.