Drug Information Journal - March 2009 - (Page 166) 166 MEDICAL INFORMATION Hyveled, Karpur, Nakskov FIGURE 4 Data quality review committee and data flow. VCC CRA DM PATIENT PROFILE DQRC DQRC REPORT Training Academy DMC ITM/CRO CRA NN IMO/CRO CRA = clinical research associate; VCC = Vanderbilt Coordination Center; DQRC = data quality review committee; DMC = data monitoring committee; ITM = international trial manager; CRO = clinical research organization; IMO = international medical officer best practices between the sites. The effect is described in the following section. S U C C E S S F U L A P P L I C AT I O N O F T H E N E W A P P R O A C H I N H E M O S TA S I S CLINICAL TRIALS Over the last four years, the first steps in the process of clinical innovation have been developed and implemented in NovoSeven hemosta18.00 sis clinical trials. The success of the New Way of Working can be illustrated using data from the recent ICH trial. First, the rate of data collection has improved, and continual monitoring of data flow indicated if there was a breakdown in processes enabling country- or center-specific problems to be identified and then rectified wherever possible (Figure 6). For example, the time from patient admission to CT scan in a particular country was identified as excessive. On investigation, it was found that CT scans for suspected ICH were not prioritized over scheduled scans; following adjustments to procedures, the time from admission to CT scan was reduced for subsequent patients. It was also found that monitoring guidelines needed to be updated more frequently to reflect queries received throughout the trial (Figure 7). Overall, as an example of how actions taken in response to continual data evaluation affect clinical trial operation, the time from symptoms to dosing with NovoSeven was reduced by 15% from start to end of the trial; this parameter is believed to be a key factor in improving outcomes in patients with ICH (Figure 8). New study tools were also developed to track FIGURE 5 16.00 Discrepancies per site compared to number of patients. Number of PT per site 14.00 12.00 10.00 8.00 6.00 4.00 2.00 0.00 Number of Discrepancies per CRF Page 1 5 10 15 20 25 30 35 Count 40 45 50 55 60 65 70
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