<< Previous Section | < Previous Page | Next Page > | Next Section >> Ethics Design In clinical research, ethical science requires quality science. Although this may be morally obvious, it's also important practically because of the huge investments in money, effort, and personal risk and discomfort that the sponsor, investigators and the participants make. But poorly designed and executed studies are frequently reported and can even influence practice and policy development. Among elements that make for poor and therefore unethical science are excessive risks compared to benefits, inadequate power, inappropriate allocation of dosages in comparison trials, poor selection and misallocation of participants, midstream changes of protocol, and failure to either monitor or record significant adverse events. An important part of research integrity is the analysis of data. It's critical to recognize the importance of appropriate statistical analysis. Statistical approaches should be developed as part of the study design. If possible, hypotheses should be well defined in advance. Current statistical packages permit the mining of entire databases to identify statistically significant results that were not anticipated. The role of such findings continues to be subject to debate. Post-hoc reasoning should be employed only to generate new hypotheses and experiments, not to resurrect a failed investigation. In therapeutic studies, both efficacy of the interventions and their safety are generally studied simultaneously but the design may focus on one or the other. << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 3 Quick Links Ethics and Study Design Introductory Ethics Design Appropriate Risk to Benefit Ratio Selection of Subject Populations Cases Bibliography Chapter 3 Download (PDF)