title: Activating clinical trials: a process improvement approach.
abstract: BACKGROUND
  The administrative process associated with clinical trial activation has been criticized as costly, complex, and time-consuming. Prior research has concentrated on identifying administrative barriers and proposing various solutions to reduce activation time, and consequently associated costs. Here, we expand on previous research by incorporating social network analysis and discrete-event simulation to support process improvement decision-making.
  
  
  METHODS
  We searched for all operational data associated with the administrative process of activating industry-sponsored clinical trials at the Office of Clinical Research of the University of South Florida in Tampa, Florida. We limited the search to those trials initiated and activated between July 2011 and June 2012. We described the process using value stream mapping, studied the interactions of the various process participants using social network analysis, and modeled potential process modifications using discrete-event simulation.
  
  
  RESULTS
  The administrative process comprised 5 sub-processes, 30 activities, 11 decision points, 5 loops, and 8 participants. The mean activation time was 76.6 days. Rate-limiting sub-processes were those of contract and budget development. Key participants during contract and budget development were the Office of Clinical Research, sponsors, and the principal investigator. Simulation results indicate that slight increments on the number of trials, arriving to the Office of Clinical Research, would increase activation time by 11 %. Also, incrementing the efficiency of contract and budget development would reduce the activation time by 28 %. Finally, better synchronization between contract and budget development would reduce time spent on batching documentation; however, no improvements would be attained in total activation time.
  
  
  CONCLUSIONS
  The presented process improvement analytic framework not only identifies administrative barriers, but also helps to devise and evaluate potential improvement scenarios. The strength of our framework lies in its system analysis approach that recognizes the stochastic duration of the activation process and the interdependence between process activities and entities.
authors.affiliation: Department of Emergency Medicine, Johns Hopkins University, 5801 Smith Avenue Baltimore, Baltimore, 21209, MD, USA. dmart101@jhmi.edu.
authors.forename: Diego A
authors.initials: DA
authors.lastname: Martinez
authors.affiliation: USF Health Program for Comparative Effectiveness Research, Department of Internal Medicine, University of South Florida, 12901 Bruce B. Downs Blvd., MDC 27, Tampa, FL, 33612, USA. atsalats@health.usf.edu.
authors.forename: Athanasios
authors.initials: A
authors.lastname: Tsalatsanis
authors.affiliation: Department of Industrial and Management Systems Engineering, University of South Florida, 4202 East Fowler Avenue, Tampa, 3360, FL, USA. ayalcin@usf.edu.
authors.forename: Ali
authors.initials: A
authors.lastname: Yalcin
authors.affiliation: Department of Industrial and Management Systems Engineering, University of South Florida, 4202 East Fowler Avenue, Tampa, 3360, FL, USA. josezaya@usf.edu.
authors.forename: José L
authors.initials: JL
authors.lastname: Zayas-Castro
authors.affiliation: USF Health Program for Comparative Effectiveness Research, Department of Internal Medicine, University of South Florida, 12901 Bruce B. Downs Blvd., MDC 27, Tampa, FL, 33612, USA. bdjulbeg@heatlh.usf.edu.|H. Lee Moffitt Cancer Center and Research Institute, 12902 USF Magnolia Drive, Tampa, 33612, FL, USA. bdjulbeg@heatlh.usf.edu.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Djulbegovic
mesh_terms: D002017:Budgets; D002986:Clinical Trials as Topic / Q000191:economics / Q000458:organization & administration* / Q000592:standards; D003198:Computer Simulation; D003657:Decision Making; D006801:Humans; D033183:Interdisciplinary Communication; D017146:Models, Organizational; D058996:Quality Improvement; D012107:Research Design / Q000592:standards; D012108:Research Personnel / Q000458:organization & administration* / Q000592:standards; D012109:Research Support as Topic / Q000458:organization & administration; D012931:Social Environment; D060756:Social Networking; D013269:Stochastic Processes; D013996:Time and Motion Studies; D057188:Workflow