Drug Information Journal - March 2009 - (Page 161) Knowledge Innovation and Clinical Operational Excellence MEDICAL INFORMATION 161 collected, critical care is associated with a high volume of data output compared with other clinical settings. For example, a diabetes trial would typically produce 450 data points per six weeks versus versus 1,250 data points in three hours for a critical care trial. Due to the large amounts of data involved and many serious adverse events, tracking of reports for the Council for International Organizations of Medical Sciences (CIOMS) became unmanageable. The number of data clarification forms (DCFs) in a diabete trial compared with an emergency trial has a workload impact of a factor 4 to 20 depending upon the trial. Furthermore, study monitoring requirements were vastly increased; a clinical research associate (CRA) might take several days to review data charts for one critical care patient, whereas it is usually possible to review data charts for a number of patients in one day in conventional clinical trials. The overwhelming amount of information produced over a minimal time period in an acute critical care trial like this places a considerable strain on resources, study tools, and the critical care trial team and creates a strong need for a flexible resource model. Overall, the standard operating procedures (SOPs) followed in conventional clinical trials did not comprehensively address the processes or provide sufficient working documents for the complex, global inpatient trials of NovoSeven. This new area of research prompted Novo Nordisk to reevaluate the standard methods of running clinical trials to provide results in a timely and more cost-efficient manner without jeopardizing quality. real-time data, and continuous adaptation is necessary to fully exploit the profusion of available information. In the knowledge economy, coping with and effectively acting upon increased information is vital for maintaining a competitive advantage. In order to maximize the usability of information and how this information is handled, new approaches to forming your decision base need to be established. The ultimate goal of knowledge innovation can be achieved by following an operational mission that divides processes into those involving data, information, knowledge, or action: • Information logistics to create the data foundations for making the right decisions. • Information supply chain management (ISCM) to create the function of information exchange. Combined with established theories, logistical supply chain management and microeconomics form the foundation for operations, but applied to data, information, and knowledge instead of a physical item. Hence, ISCM is ensuring the right information will be delivered to the right person at the right time. • Data intelligence to create the knowledge needed for decision-making processes so that problems can be identified and acted upon as quickly as possible. • Knowledge leadership to establish the optimal environment for exchange of actions: —Knowledge management to establish control of and measure the impact of knowledge; —Change preparedness to continue the process until actions prompt the desired outcome. • Knowledge innovation will then arise from information exchange between functions and people that was not previously taking place. I M P R O V I N G I N F O R M AT I O N MANAGEMENT BY TRANSFORMING CLINICAL TRIALS Conventional approaches to problem solving are not sufficient for today’s high-data-volume clinical trials, particularly those in new and pioneering areas with no regulatory or treatment guidelines such as critical care. Pharmaceutical companies need to recognize that frequent changes occur as a result of increased knowledge from the increased information flow and technology solutions that provide access to Maintaining continuous communication between information logistics, ISCM, and data intelligence and establishing actions that produce the desired outcome is essential for success and knowledge innovation in clinical trials, as each function has an impact on the others. The ultimate goal is to establish a self-sustainable environment of information, knowledge exchange, and implementation of flexible actions until the required outcome is attained. Implementing such changes in clinical trial Drug Information Journal
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