Research For Clinical Trials

Many practicing clinical surgeons engage in clinical research, either for a new medication, a new surgical procedure, or other innovation. The simple reporting of a series of cases to the literature has yielded to the randomized, double-blind clinical trial, adding a new level of scientific rigor to the research and reporting of new therapies. This requirement for "evidence-based medicine" is significantly increasing the quality of research and improving overall patient care; however, the time and cost involved in conducting such rigorous trials are enormous and have delayed many new therapeutic options. In addition, it is not possible to know the final outcomes in many instances, such as cancer, where it takes 20 years or longer until the long-term results (including possible complications) are known. However, other industries have been using modeling and simulation to predict outcomes into the future. Theoretically, the day will come when a virtual clinical trial will use predictive simulation of a therapy on a million patients over 50 years—on one week of supercomputer time. The accuracy of such predictions will be determined by how accurate the models of humans can become, from the genetic and cellular all the way to the organ and whole body level. Today drug companies are using "rational drug design" by computer programs and then doing virtual testing and evaluation of the products based upon the pharmacologic properties. This is the first step toward doing "predictive simulation" for clinical trials. The advantage for surgeons is that it will be possible to provide much more accurate information on the efficacy of drugs or surgical procedures that is available today as well as to customize the therapy for each patient.

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