The Tennessee Department of Health workshops on use of secondary data for community health assessment, 2012.

Community health assessment is a core function of public health departments, a standard for accreditation of public health departments, and a core competency for public health professionals. The Tennessee Department of Health developed a statewide initiative to improve the processes for engaging county health departments in assessing their community's health status through the collection and analysis of secondary data. One aim of the Tennessee Department of Health was to position county public health departments as trusted leaders in providing population data and engaging community stakeholders in assessments. The Tennessee Department of Health's Division of Policy, Planning, and Assessment conducted regional 2-day training workshops to explain and guide completion of computer spreadsheets on 12 health topics. Participants from 93 counties extracted data from multiple and diverse sources to quantify county demographics, health status, and resources and wrote problem statements based on the data examined. The workshops included additional staff development through integration of short lessons on data analysis, epidemiology, and social-behavior theory. Participants reported in post-workshop surveys higher degrees of comfort in interpreting data and writing about their findings on county health issues, and they shared their findings with health, hospital, school, and government leaders (including county health council members) in their counties. Completion of the assessments enabled counties and the Tennessee Department of Health to address performance-improvement goals and assist counties in preparing to meet public health accreditation prerequisites. The methods developed for using secondary data for community health assessment are Tennessee's first-phase response to counties' request for a statewide structure for conducting such assessments.

Steps and time to process clinical trials at the Cancer Therapy Evaluation Program.

PURPOSE: To examine the processes and document the calendar time required for the National Cancer Institute's Cancer Therapy Evaluation Program (CTEP) and Central Institutional Review Board (CIRB) to evaluate and approve phase III clinical trials. METHODS: Process steps were documented by (1) interviewing CTEP and CIRB staff regarding the steps required to activate a trial from initial concept submission to trial activation by a cooperative group, (2) reviewing standard operating procedures, and (3) inspecting trial records and documents for selected trials to identify any additional steps. Calendar time was collected from initial concept submission to activation using retrospective data from the CTEP Protocol and Information Office. RESULTS: At least 296 distinct processes are required for phase III trial activation: at least 239 working steps, 52 major decision points, 20 processing loops, and 11 stopping points. Of the 195 trials activated during the January 1, 2000, to December 31, 2007, study period, a sample of 167 (85.6%) was used for gathering timing data. Median calendar days from initial formal concept submission to CTEP to trial activation by a cooperative group was 602 days (interquartile range, 454 to 861 days). This time has not significantly changed over the past 8 years. There is a high variation in the time required to activate a clinical trial. CONCLUSION: Because of their complexity, the overall development time for phase III clinical trials is lengthy, process laden, and highly variable. To streamline the process, a solution must be sought that includes all parties involved in developing trials.

Development of clinical trials in a cooperative group setting: the eastern cooperative oncology group.

PURPOSE: We examine the processes and document the calendar time required to activate phase II and III clinical trials by an oncology group: the Eastern Cooperative Oncology Group (ECOG). METHODS: Setup steps were documented by (a) interviewing ECOG headquarters and statistical center staff, and committee chairs, (b) reviewing standard operating procedure manuals, and (c) inspecting study records, documents, and e-mails to identify additional steps. Calendar time was collected for each major process for each study in this set. RESULTS: Twenty-eight phase III studies were activated by ECOG during the January 2000 to July 2006 study period. We examined a sample from 16 of those studies in detail. More than 481 distinct processes were required for study activation: 420 working steps, 61 major decision points, 26 processing loops, and 13 stopping points. Median calendar days to activate a trial in the phase III subset was 783 days (range, 285-1,542 days) from executive approval and 808 days (range, 435-1,604 days) from initial conception of the study. Data were collected for all phase II and phase III trials activated and completed during this time period (n = 52) for which development time represented 43.9% and 54.1% of the total trial time, respectively. CONCLUSION: The steps required to develop and activate a clinical trial may require as much or more time than the actual completion of a trial. The data shows that to improve the activation process, research should to be directed toward streamlining both internal and external groups and processes.