Drug Information Journal - March 2009 - (Page 163) Knowledge Innovation and Clinical Operational Excellence MEDICAL INFORMATION 163 Vision for Achieving Clinical Operational Excellence and Knowledge Innovation • Knowledge distribution and accessibility creates the foundation for innovation. • Bringing people of various skill types together and sharing information and knowledge will diminish the silo mentality. • It is important to create a balance in clinical trial conduct between standards and creative chaos. • It is the ability to handle increasing amounts of information and identify the actions necessary to achieve the desired outcome that establishes the competitive advantage. • Information management can facilitate change preparedness. TABLE 1 knowledge, and actions previously defined, namely information logistics, ISCM, data intelligence, knowledge leadership, knowledge management, change preparedness, and finally knowledge innovation. Together, the vision and operational mission provided a foundation for the transformation needed, taking account of the human and cultural changes required for trial staff to adapt to and accept the inherent unpredictability of clinical research conducted using the New Way of Working. CLINICAL OPERATIONAL PLAN One of the major components of the New Way of Working is the clinical operational plan (COP). It is essential that a COP is prepared and committed to before the trial is started to ensure individual trial process description and alignment of expectations and delivery; that is, each COP, which remains a live and flexible document throughout the trial, is an idea catalog initiator providing prompts for different aspects of individual trials to be considered, rather than a rigid framework that is followed without adaptation. The COP should therefore not be thought of as a template, rather a modifiable framework for information logistics that in turn forms the basis for ISCM. In addition, the COP allows for the continual evaluation needed to address problems as they arise during the trial. As there is considerable variation in design from trial to trial, each COP is individually tailored and adapted as appropriate, with components including an internal resource or outsourcing plan, a communication plan, a recruitment strategy, a risk analysis plan, a data-handling plan, a data quali- ty review committee, and a training plan. A successful COP will prevent a buildup of problems at the study’s end through continual evaluation and corrective action. It is also important to note that the COP is designed to be a supportive function for the clinical trial team rather than a means of surveillance. Parallel processing, based upon information control and coordination, is an integral part of the New Way of Working (Figure 1). The aim of optimizing the clinical trial process in this way is to reduce the overall time from trial start to results. The trial validation plan is constantly reviewed and updated to reflect what is really happening in the study, such that self-evident correction is established. Feedback to appropriate trial personnel helps to avoid the repetition of problems as the trial continues. The frequency of data reporting will vary according to the needs of the individual clinical trial, and most likely according to the stage of the trial (eg, frequently at the study start to detect early problems, less often once the trial is up and running, and increasing again at the study’s end). Moreover, a myriad of data sources will be used (data intelligence) and transferred to clear and transparent overview formats to establish a decision foundation for the actions that need to be taken to generate the desired outcome. Throughout the trial, the ability to rapidly disseminate data and information to the relevant person or group helps to avoid the anxiety resulting from a lack of information. The essence is very simple: all stakeholders have influence upon others and as such the processes needs iterative updates. The coordination and control of information makes Drug Information Journal
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