Drug Information Journal - March 2009 - (Page 162) 162 MEDICAL INFORMATION Hyveled, Karpur, Nakskov operations will require clear leadership, considerable adaptation, and flexibility from the personnel involved, in the tools available to them and, perhaps most important, the general way of thinking about processes. Transforming clinical trials will require a significant change in mindset, particularly in an era when there is certain reluctance to deviate from SOPs. Strict adherence to SOPs, historically required by the International Conference on Harmonization Good Clinical Practice (GCP) guidelines and regulatory bodies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMEA), has resulted in a loss of individuality. This may be because SOPs often have been written in a way that reduces flexibility, increases workload, and is more stringent than required for regulatory purposes. As an example, the standard case report form SOP assumes all patients are relevant for an unscheduled visit form or a pregnancy test form; however, if the trial is an acute critical care trial that involves collecting data over a short time period which includes only one dose during patient hospitalization or a pregnancy-safe drug in the dosage used, these pages may be irrelevant, but an SOP deviation must be written as it is mandatory in company SOPs. Moreover, clinical trials are conventionally conducted in silos, with individual people or groups responsible only for their particular section with little understanding of the common goal; operational reciprocity needs to be reintroduced. Instead of progressing through the conventional linear process of a trial, personnel will need to adapt to the unpredictability inherent in clinical research and embrace the requirement for continual evaluation, addressing problems as they occur. Taking ownership for the end-to-end process and receiving adequate support and training will help clinical trial staff to become fully prepared for change. Indeed, participation in the process will in itself illustrate the benefits of maintaining information flow and knowledge exchange. The culture of hierarchical organization characteristic of the pharmaceutical industry and many other business areas is no longer benefi- cial for growth and may actually be a limitation. Horizontal structures, such as networks of autonomous teams, are more relevant in the knowledge-based economy (6). It has been proposed that the integrative team approach may enhance the efficiency of productivity in pharmaceutical research and development, which is increasingly becoming an environment of heightened performance pressure and greater resource limitations, ultimately conferring a competitive advantage for the company. Upper management support is a key for the adoption of new processes in the clinical trial setting, with success dependent on the provision of agile, robust tools to provide intelligent, practical solutions in an efficient and cost-effective way. Tools should be responsive to internal dynamics, capable of anticipating and adapting to changing conditions, and suitable for parallel processing. Overall, implementation of the operational changes outlined above aims to reduce the total time from trial start to database release while improving the quality of data. Optimizing the clinical trial process in this way establishes a basis for clinical operational excellence and continuous knowledge innovation. MAXIMIZING THE OPPORTUNITY F O R K N O W L E D G E I N N O VAT I O N : A N E W W AY O F W O R K I N G Novo Nordisk NovoSeven Key Projects has developed and implemented a new model for clinical trial operations, termed the New Way of Working. This was originally developed in response to the problems encountered during early investigations into the effects of NovoSeven treatment in critical care patients. However, this approach is intended for use in all clinical trials to optimize processes and establish clinical operational excellence. As part of the overall strategy devised by Novo Nordisk, one of the first steps taken was to create a vision for clinical operational excellence to ensure the process was developed in a controlled and focused manner, particularly during the early phase (Table 1). The operational mission was based on the steps for optimal handling of data, information,
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