Journal of critical care
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Journal of critical care · Dec 2008
ReviewImportant issues in the design and reporting of clinical trials in severe sepsis and acute lung injury.
Severe sepsis and acute lung injury are challenging diagnoses as they relate to designing and reporting of clinical trials. The limited success in bringing forward new therapies in these areas is likely proof of that premise. The ability to use preclinical and phase I and II trial data to predict which patients and which dosing regimens are more likely to benefit is perhaps the greatest challenge. ⋯ Conflict of interest issues which rested dormantly for years are now at the forefront of discussion, and journal editorial board responsibility in this area is being recognized. Protocols may also help reduce heterogeneity of treatment across centers in clinical trials. This article reviews many of the problems encountered in clinical trial design and reporting and offers a perspective on dealing with them to the betterment of a clinical trial.
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The purpose of this review is to introduce differential equations as a simulation tool in the biological and clinical sciences. This modeling technique is very mature and has been a preferred tool of physiologists and bioengineers and of quantitative scientists in general to describe and predict the behavior of complex interacting systems. ⋯ We conclude that the usefulness of quantitative modeling, including equation-based models, is ultimately linked to the quality and abundance of observation obtained on the system being modeled. Equation-based modeling, although potentially an integrative approach, is complementary to and extends the potential of traditional statistically based approaches to inference.