Drug Information Journal - March 2009 - (Page 160) 160 MEDICAL INFORMATION Hyveled, Karpur, Nakskov able to them. Furthermore, there is a misconception that the increasing number of technological devices available will help to offset the problems of information overload. Although technological developments are useful (eg, electronic data capture), they do not improve people’s capability to deal with the information. If too much data are generated without sufficient information management strategies, there is a substantial risk that some may be ignored, wasted, or lost. For Novo Nordisk A/S, a focused health care company founded on the treatment of diabetes and pioneering in the area of critical bleeding, the impact of increased information has become most apparent during the expansion of NovoSeven (recombinant activated factor VII) from the hemophilia indication to general hemostatic management. THE CHALLENGE OF CRITICAL CARE RESEARCH The complex, fast-paced, unpredictable, and highly demanding nature of the critical care environment makes it a difficult setting in which to conduct clinical trials. Treatment practices may vary from country to country and primarily depend on available resources, location of trauma centers and emergency units, and local standard guidelines. Critical care personnel need to make rapid decisions and respond quickly to each individual situation in order to focus on their main priority of patient survival, so collection of trial data is of secondary concern. In addition, each patient is unique in terms of medical profile, necessitating different approaches to individual patient management. However, improving the pharmacological management of critical care patients has the potential to save lives and reduce the high morbidity seen in this population (3). For example, traumatic injury accounted for approximately 10% of all recorded deaths worldwide in the year 2000, while survivors of traumatic injury often experience considerable and persistent morbidity resulting in a significant burden on the patients and health care resources (3). Similarly, ICH is associated with poor short- and long-term outcomes, with a one-month mortality rate of approximately 40–50% (4,5). It is therefore important to continue to find ways of improving critical care clinical trials to maximize the potential for introducing new and effective treatments for critical care patients. NovoSeven clinical trials in the critical care setting began in 2001, and Novo Nordisk was faced with a range of challenges. Most previous research had been conducted in chronic diseases such as diabetes and hemophilia in patient populations with similar profiles; critical care is a very different situation requiring considerable adaptation of processes. One of the main differences Novo Nordisk found was that the acute critical care setting generally involves multiple hospital departments, and the complexities of hospital flow needed to be fully understood. In terms of the amount of information NOVO NORDISK: EXPANDING HORIZONS Nordisk Insulin Laboratories was founded in 1922 by August Krogh, a professor of physiology, and Hans Christian Hagedorn, a specialist in the regulation of blood sugar. In March 1923, only two years after the discovery of insulin in Canada, patients who had diabetes began to be treated with Nordisk insulin extracted using innovative methods from bovine pancreas. In 1924, a second company, Novo Terapeutisk Laboratorium, was founded by two former employees of Nordisk, brothers Harald and Thorvald Pedersen. They also began successfully producing insulin, along with a special syringe with which patients could inject themselves with insulin. These two Danish companies developed into the world’s leading manufacturers of diabetes treatments, producing highly purified insulin products, human insulin, and elegant pen devices. In 2000, Novo Nordisk decided to broaden their research and development in the area of biopharmaceuticals. An initial step was taking NovoSeven into general hemostasis management, initially in elective surgery, acute critical care such as intracerebral hemorrhage (ICH), and trauma patients.
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